Cutaneous T-Cell Lymphoma, Mature T-cell Malignancies, Peripheral T-Cell Lymphoma, Relapsed/ Refractory T-cell Malignancies
Conditions
Keywords
Immunomodulatory Drugs (IMiDs), TCM, ALCL, Histone Deacetylase Inhibitors (HDACi)
Brief summary
Background: Mature T-cell malignancies (TCMs) are a rare group of cancers that usually do not have effective treatments or cures. Because of this, participants with TCMs often relapse and have a poor overall prognosis. This trial is testing if combining several drugs against TCMs can be a more effective. Primary Objective: To test if the combination of romidepsin, CC-486 (5-azacitidine), dexamethasone, and lenalidomide (RAdR) can be given safely to participants with relapsed or treatment refractory TCM. Other (Secondary) Objective: Measure the activity of this combination treatment. Eligibility: People age 18 and older who have a failed or relapsed after standard treatments for mature TCMs. Design: Participants will be screened for eligibility by performing the following tests or procedures: Physical exam Medical history Medicine review Blood and urine tests Symptom review Bone marrow examination Total Body imaging scans or x-rays Tumor biopsy Participants will have blood tests during treatment to make sure their blood cell counts are okay. Romidepsin is infused through an intravenous (IV) placed in one of the veins usually in the arm. Lenalidomide, dexamethasone, and CC-486 (5-azacitidine) are pills or capsules taken by mouth. Participants are asked to keep a diary of when they take their pills to make sure they are taking these medicines properly. Participants will have tumor imaging scans after every 2nd cycle (or 6 weeks) to check if the treatment is working. If the doctors are concerned the cancer has spread to the brain and/or spine, they will have scans of the area(s) and a sampling of the fluid around the brain/spine which is obtained through a small needle inserted into the lower part of the back for a short time to collect the fluid. This procedure is called a spinal tap or lumbar puncture. Participants who have tumor in their skin will have repeat exams of their skin and sometimes photographs taken of these areas to see if the treatment is working. Participants will also be asked to give blood, saliva, and sometimes have optional biopsies of their tumor where these tests are done for research purposes. After they have completed the protocol treatment (6 cycles), they will be asked to return to clinic 30 days after treatment has ended, then every other month (or 60 days) for the first 6 months, then every 3 months (90 days) for 2 years, and then every 6 months for years 2 to 4 after completing treatment. After 4.5 years, they will be seen once a year.
Detailed description
Background: * Mature T-cell malignancies (TCM) are rare and heterogeneous group of leukemias and lymphomas accounting for 5 to 10% of all lymphomas in the US * Patients with systemic TCM are most commonly treated with a CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone)-like regimens, that produce long-term progression-free survival in about 30% of these cases * Patients with relapsed/refractory (R/R) TCM have very poor prognosis with median overall survival of less than 1 year. Treatment options for R/R TCM are very few and of limited efficacy, thus novel treatment strategies are urgently needed. * Mutations in epigenetic regulators are common in aggressive TCMs and standard treatment with histone deacetylase inhibitors (HDACi) such as romidepsin show modest clinical activity with single agent the overall response (ORR) around 25% * Combination of romidepsin and 5-azacitidine (hypomethylating agents) was synergistic in preclinical models, and has demonstrated high clinical activity with an ORR of 79% * Many TCMs rely on The Ikaros-dependent nuclear factor κB (NF-κB)/interferon regulatory factor 4 (IRF4) signaling pathway to maintain proliferation, which is why lenalidomide, which induces degradation of Ikaros and downregulates IRF4, has single agent activity in R/R TCM with overall response rate (ORR) of 26% to 42%, depending on the subtype. * Lenalidomide synergizes with romidepsin and enhances tumor cell death in TCM cell lines, predicting that the addition of lenalidomide to the established romidepsin/ CC-486 (5-azacitidine) combination will further improve efficacy. Objectives: -To determine the safety and toxicity profile and the maximum tolerated dose (MTD) of the four-drug combination of CC-486 (5-azacitidine), romidepsin, lenalidomide and dexamethasone in patients with TCM Eligibility: * Refractory/relapsed TCM (excluding in Cutaneous T-Cell Lymphoma) defined as follows: * Patients with systemic disease * Have received at least one line of prior therapy * Must have received brentuximab vedotin if the disease is anaplastic large cell lymphoma or cluster of differentiation 30 (CD30)-positive cutaneous T-cell lymphoma * Age \>= 18 years of age * Eastern Cooperative Oncology Group performance status of \<= 2 (or \<= 3 if decrease is due to the disease) * Histologically or cytologically confirmed relapsed and/or refractory mature TCM * Adequate organ and marrow function Design: * Open-label, single-center, uncontrolled Phase 1 study * 3 + 3 design will be used to determine the maximum tolerated dose (MTD) of dose-escalated lenalidomide with fixed dose of romidepsin and CC-486 (5-azacitidine) * An expansion cohort of 9 patients will be evaluated at the MTD * Maximum 6 cycles (28-day cycle) of combination therapy * To explore all dose levels, including further evaluation in a dose expansion cohort, the accrual ceiling will be set at 30 patients
Interventions
Romidepsin (12mg/ m\^2) will be administered on days 1 and 10 of each cycle through a peripheral or central intravenous catheter for 6 cycles.
Lenalidomide will be administered by oral intake in a dose-escalation with a starting dose of 5mg daily, a second dose level of 10mg daily, a third dose level at 15mg daily, and a fourth dose level at 20mg daily on days -7 to day 10 of first cycle. After the second cycle, lenalidomide will be given from day 1 to day 10 in each cycle for up to 6 cycles.
CC-486 (5-azacitidine) with a dose of 300mg oral intake daily will be given on day 1 to day 10 for 6 cycles.
Dexamethasone, 40mg, by mouth (PO), will be given on days 1 and 10 of each cycle.
Screening
Baseline, end of treatment and disease progression, and Day 30 (+7).
Baseline, every 2 cycles, end of treatment and disease progression, and follow-up.
Baseline, every 2 cycles, end of treatment and disease progression, and follow-up.
Screening
Sponsors
Study design
Eligibility
Inclusion criteria
* INCLUSION CRITERIA: * Patients must have relapsed after or progressed during at least one line of prior systemic therapy (which may include allogeneic stem cell transplantation) for mature T or NK/T neoplasm, i.e. have relapsed and/or refractory mature T and natural killer (NK) neoplasm per 2016 World Health Organization (WHO) classification excluding chronic lymphoproliferative disorder of NK cells, aggressive NK-cell leukemia, and Cutaneous T-Cell Lymphoma. * T or NK/T neoplasm from initial diagnosis or recurrence must be histologically or cytologically proven and diagnosis be confirmed by the Laboratory of Pathology, National Cancer Institute (NCI), * Patients with anaplastic large cell lymphoma (ALCL) or cluster of differentiation (CD30) positive mycosis fungoides (MF) or Sézary syndrome (SS) must have relapsed after or become intolerant to prior anti-CD30 targeting therapy treatment with brentuximab vedotin * For patients without circulating leukemia/lymphoma cells detectable by flow cytometry, a formalin fixed tissue block or 15 slides of tumor sample (archival or fresh) must be available at enrollment for performance of correlative studies. NOTE: Patients without circulating malignant cells must be willing to have a tumor biopsy if prior tissue or adequate archival tissue is not available (i.e., post-enrollment and prior to treatment). * Disease must be measurable with at least one measurable lesion by response evaluation criteria in lymphoma (RECIL) 2017 or Modified Severity-Weighted Assessment Tool (mSWAT) criteria, or have an abnormal clonal T-cell population detectable by peripheral blood flow cytometry * Age \>18 years * Eastern Cooperative Oncology Group (ECOG) performance status \<=2, or \<= 3 if the decreased performance status is deemed to be due to disease and not residual toxicity from prior therapy or other causes. * Adequate organ and marrow function as defined below: * Absolute neutrophil count \>= 1,000/mcL * Platelets \>= 75,000/mcL * Total bilirubin \<= 1.5 X institutional upper limit of normal (ULN) * Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT)/alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) \<= 2.5 X institutional upper limit of normal (ULN) * Serum Creatinine \<= 1.5 mg/dL OR * Creatinine Clearance \>= 60 mL/min/1.73 m\^2 as calculated by direct measurement of 24-hour urine for creatinine clearance * Negative serum or urine pregnancy test at screening for women of childbearing potential (WOCBP) NOTE: WOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal. WOCBP must have a negative pregnancy test (hemoglobin (HCG) blood or urine) during screening. * All study participants must be registered into the mandatory Revlimid REMS(R) program and be willing and able to comply with the requirements of the Risk Evaluation and Mitigation Strategy (REMS(R) program. * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for at least 6 months after completion of treatment for women, and for at least 3 months after completion of treatment for men. Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS(R) program. * Ability of subject to understand and the willingness to sign a written informed consent document.
Exclusion criteria
* Patients who are receiving any other investigational agents. * Anti-cancer treatment within 2 weeks prior to enrollment. (4 weeks for monoclonal antibodies and 6 weeks for nitrosoureas or mitomycin C). * Patients who have received two of the following drugs at any point: lenalidomide, romidepsin, and 5-azacitidine. Patients who have received only one of the three drugs remain eligible. * Patients with a diagnosis of cutaneous T-cell lymphoma (CTCL) are excluded from participation in the expansion cohort. * Other malignancy that requires ongoing systemic hormonal therapy, chemotherapy, or immunotherapy. * History of allergic reactions or known or suspected hypersensitivity attributed to compounds of similar chemical or biologic composition to lenalidomide, romidepsin and 5-azacitidine * Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring systemic therapy, or psychiatric illness/social situations that would limit compliance with study requirements. * Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial. * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. * History of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), celiac disease (i.e., sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the study drug and/or predispose the subject to an increased risk of gastrointestinal toxicity. * Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\< 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment), unstable angina, congestive heart failure (\>= New York Heart Association Classification Class II), congenital long QT syndrome, or other serious cardiac arrhythmia including 2nd degree atrio ventricular (AV) block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min). * Hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other causes. * Uncontrolled hypertension, i.e., blood pressure (BP) of \>=160/95; patients who have a history of hypertension controlled by medication must be on a stable dose (for at least one month) and meet all other inclusion criteria. * Triplicate average baseline QT corrected for heart rate by Fridericia's (QTcF) interval \>= 480 ms * Patients taking drugs leading to significant QT prolongation Note: A 5 half-life washout period must have elapsed following the use of these drugs prior to administration of romidepsin. * Concomitant use of rifampin and other strong cytochrome P450 3A4 (CYP3A4) inhibitors and inducers within 2 weeks prior to starting protocol therapy. * Other severe acute or chronic medical conditions including psychiatric conditions such as recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study. * Pregnant or lactating women. Pregnant women are excluded from this study because lenalidomide is a Class X agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with lenalidomide, breastfeeding should be discontinued if the mother is treated with lenalidomide. These potential risks may also apply to other agents used in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | 6 cycles (each cycle is 28 days) | Treatment emergent grades 3, 4, and/or 5 adverse events possibly related grouped by relationship to the study drug (e.g., lenalidomide, romidepsin, CC-486 (5-azacitidine) in any combinations) assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life threatening. Grade 5 is death related to adverse event. |
| Maximum Tolerated Dose (MTD) | 21 days | The MTD is the dose level at which no more than 1 of up to 6 participants experience dose-limiting toxicity (DLT) during the DLT evaluation window(s), or the dose below that at which at least 2 (of ≤6) participants have DLT. A DLT is defined as any treatment-emergent and related severe (grade ≥3) toxicity related to lenalidomide, romidepsin and/or CC-486 (5-azacitidine) and occurring during the maximum tolerated dose (MTD) observation time, defined as day -7 until end of cycle 1 (normally day 22). |
| Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | 6 cycles (each cycle is 28 days) | Rate and severity of AEs will be summarized by grade and type of toxicity. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event. |
| Number of Treatment Emergent Grades 3, 4 and/or 5 Adverse Events Possibly Related to Drug Grouped by Severity | 6 cycles (each cycle is 28 days) | Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event. |
| Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | 6 cycles (each cycle is 28 days) | Treatment emergent grades 3, 4, and/or 5 adverse events possibly related grouped by relationship to the study drug (e.g., lenalidomide, romidepsin, CC-486 (5-azacitidine) in any combinations) assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life threatening. Grade 5 is death related to adverse event. |
| Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | 6 cycles (each cycle is 28 days) | Treatment emergent grades 3, 4, and/or 5 adverse events possibly related grouped by relationship to the study drug (e.g., lenalidomide, romidepsin, CC-486 (5-azacitidine) in any combinations) assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life threatening. Grade 5 is death related to adverse event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DOR) in Months Reported Along With a 95% Confidence Interval | up to a median of 11.7 months | DOR will be determined and reported along with a 95% confidence interval. DOR is measured from the time measurement criteria are met for complete response (CR) or partial response (PR (whichever is recorded first) until the first date that recurrent or progressive disease is objectively documented. Response was measured by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria. Complete response (CR) is disappearance of all target lesions and all nodes with long axis \<10mm. Partial response (PR) is a ≥30% decrease in the sum of longest diameters of target lesions but not a CR. Progressive disease is \>20% increase in the sum of longest diameters of target lesions. |
| Overall Response Rate (Complete Response + Partial Response) | 6 cycles (each cycle is 28 days) | The response rate will be estimated using the Kaplan-Meier curve and reported along with a 95% confidence interval. Response was measured by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria. Complete response (CR) is disappearance of all target lesions and all nodes with long axis \<10mm. Partial response (PR) is a ≥30% decrease in the sum of longest diameters of target lesions but not a CR. |
| Progression-free Survival (PFS) in Months Reported Along With a 95% Confidence Interval | up to a median of 13.1 months | PFS will be estimated using the Kaplan-Meier curve and reported along with a 95% confidence interval. PFS is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, or death, whichever occurs first measured by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria. Progressive disease is \>20% increase in the sum of longest diameters of target lesions. Disease relapse is defined as new areas of disease or \>50% increase in growth of target lesion. |
| Complete Response Rate (CRR) | 6 cycles (each cycle is 28 days) | CRR will be estimated using the Kaplan-Meier curve and reported along with a 95% confidence interval. Response was measured by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria. Complete response (CR) is disappearance of all target lesions and all nodes with long axis \<10mm. |
| Overall Survival (OS) | up to a median of 8.7 months | OS will be estimated using the Kaplan-Meier curve and reported along with a 95% confidence interval. OS is defined as the time from the date of study enrollment until time of death from any cause. |
Countries
United States
Contacts
National Cancer Institute (NCI)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide T-cell Malignancies, Dose Escalation, Arm 1, Dose Level -1 Arm 1, Dose Level-1: Lenalidomide 2.5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 200 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD). | 2 |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 1 Arm 1, Dose Level 1: Lenalidomide 5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD). | 6 |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 2 Arm 1, Dose Level 2: Lenalidomide 10 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD). | 6 |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 3 Arm 1, Dose Level 3: Lenalidomide 15 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD). | 3 |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 4 Arm 1, Dose Level 4: Lenalidomide 20 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD). | 3 |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 2 Arm 2, Dose Level 2: Lenalidomide by oral intake at maximum tolerated dose (MTD) on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined. | 2 |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 4 Arm 2, Dose Level 4: Lenalidomide by oral intake at maximum tolerated dose (MTD) Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined. | 1 |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide T-cell Malignancies, Dose Expansion, Arm 3, Dose Level 4 Arm 3, Dose Level 4: Lenalidomide 20 mg maximum tolerated dose (MTD) by oral intake at on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined. | 3 |
| Total | 26 |
Baseline characteristics
| Characteristic | Total | Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide | Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide | Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide | Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide | Arm 1, Cohort 1, Dose Level 3 Dose Escalation | Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide | Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide | Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 1 Participants | 1 Participants | 1 Participants | 3 Participants | 3 Participants | 5 Participants | 4 Participants | 1 Participants |
| Age, Continuous | 58 years STANDARD_DEVIATION 13.46 | 62.67 years STANDARD_DEVIATION 21.73 | 65 years STANDARD_DEVIATION 0 | 66.5 years STANDARD_DEVIATION 9.19 | 46.67 years STANDARD_DEVIATION 16.29 | 46.33 years STANDARD_DEVIATION 14.19 | 55.67 years STANDARD_DEVIATION 8.07 | 63.17 years STANDARD_DEVIATION 11.46 | 65 years STANDARD_DEVIATION 15.56 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 10 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 3 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Ethnicity Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized More Than One Race | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 23 Participants | 2 Participants | 1 Participants | 2 Participants | 2 Participants | 3 Participants | 6 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Unknown or Not Reported | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 8 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 2 Participants | 0 Participants |
| Region of Enrollment United States | 26 participants | 3 participants | 1 participants | 2 participants | 3 participants | 3 participants | 6 participants | 6 participants | 2 participants |
| Sex: Female, Male Female | 7 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Male | 19 Participants | 3 Participants | 1 Participants | 1 Participants | 3 Participants | 2 Participants | 4 Participants | 4 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 2 | 3 / 6 | 3 / 6 | 1 / 3 | 0 / 3 | 1 / 2 | 1 / 1 | 0 / 3 |
| other Total, other adverse events | 2 / 2 | 6 / 6 | 6 / 6 | 3 / 3 | 3 / 3 | 2 / 2 | 1 / 1 | 3 / 3 |
| serious Total, serious adverse events | 0 / 2 | 2 / 6 | 1 / 6 | 2 / 3 | 0 / 3 | 0 / 2 | 0 / 1 | 0 / 3 |
Outcome results
Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Treatment emergent grades 3, 4, and/or 5 adverse events possibly related grouped by relationship to the study drug (e.g., lenalidomide, romidepsin, CC-486 (5-azacitidine) in any combinations) assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life threatening. Grade 5 is death related to adverse event.
Time frame: 6 cycles (each cycle is 28 days)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Lymphocyte count decreased | 1 adverse events |
| All Participants | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Atrial fibrillation | 0 adverse events |
| All Participants | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 or 5 Any Serious Adverse Event | 0 adverse events |
| All Participants | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anemia | 2 adverse events |
| All Participants | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Anorexia | 0 adverse events |
| All Participants | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Platelet count decreased | 1 adverse events |
| All Participants | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Ejection fraction decreased | 0 adverse events |
| All Participants | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Hypokalemia | 0 adverse events |
| All Participants | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Neutrophil count decreased | 0 adverse events |
| All Participants | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-Serious Platelet count decreased | 0 adverse events |
| All Participants | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious White blood cell decreased | 0 adverse events |
| All Participants | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Fatigue | 0 adverse events |
| All Participants | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Weight loss | 0 adverse events |
| All Participants | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Non-serious Platelet count decreased | 1 adverse events |
| All Participants | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Non-serious Neutrophil count decreased | 0 adverse events |
| All Participants | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 White blood cell decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 White blood cell decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Lymphocyte count decreased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Anorexia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Non-serious Neutrophil count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Non-serious Platelet count decreased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 or 5 Any Serious Adverse Event | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Weight loss | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Fatigue | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious White blood cell decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-Serious Platelet count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anemia | 2 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Atrial fibrillation | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Neutrophil count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Hypokalemia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Ejection fraction decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Platelet count decreased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious White blood cell decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Platelet count decreased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Lymphocyte count decreased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Anorexia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-Serious Platelet count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Non-serious Neutrophil count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Hypokalemia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Non-serious Platelet count decreased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Neutrophil count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 White blood cell decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 or 5 Any Serious Adverse Event | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Atrial fibrillation | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Weight loss | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anemia | 2 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Fatigue | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Ejection fraction decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Atrial fibrillation | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 or 5 Any Serious Adverse Event | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anemia | 2 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Lymphocyte count decreased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Platelet count decreased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Ejection fraction decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 White blood cell decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Hypokalemia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Neutrophil count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-Serious Platelet count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious White blood cell decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Fatigue | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Weight loss | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Non-serious Platelet count decreased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Non-serious Neutrophil count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Anorexia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 White blood cell decreased | 2 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anemia | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-Serious Platelet count decreased | 3 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Neutrophil count decreased | 4 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Atrial fibrillation | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Non-serious Neutrophil count decreased | 2 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Ejection fraction decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Non-serious Platelet count decreased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Platelet count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Weight loss | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 or 5 Any Serious Adverse Event | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Anorexia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Hypokalemia | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Lymphocyte count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Fatigue | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious White blood cell decreased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-Serious Platelet count decreased | 3 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Weight loss | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Hypokalemia | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 White blood cell decreased | 2 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious White blood cell decreased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Neutrophil count decreased | 4 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Fatigue | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Non-serious Neutrophil count decreased | 2 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Lymphocyte count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Atrial fibrillation | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Non-serious Platelet count decreased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Anorexia | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anemia | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Ejection fraction decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Platelet count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 or 5 Any Serious Adverse Event | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Atrial fibrillation | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Platelet count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Ejection fraction decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Anorexia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anemia | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Hypokalemia | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Neutrophil count decreased | 4 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-Serious Platelet count decreased | 3 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 White blood cell decreased | 2 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious White blood cell decreased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 or 5 Any Serious Adverse Event | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Fatigue | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Weight loss | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Non-serious Platelet count decreased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Non-serious Neutrophil count decreased | 2 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Lymphocyte count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-Serious Platelet count decreased | 3 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Hypokalemia | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 or 5 Any Serious Adverse Event | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 White blood cell decreased | 2 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Neutrophil count decreased | 4 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Platelet count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Atrial fibrillation | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Non-serious Neutrophil count decreased | 2 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Lymphocyte count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Non-serious Platelet count decreased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anemia | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Ejection fraction decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Weight loss | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Anorexia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Fatigue | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious White blood cell decreased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 or 5 Any Serious Adverse Event | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-Serious Platelet count decreased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Lymphocyte count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious White blood cell decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Hypokalemia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Fatigue | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 White blood cell decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Weight loss | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Ejection fraction decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Non-serious Platelet count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anemia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Non-serious Neutrophil count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Atrial fibrillation | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Platelet count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Neutrophil count decreased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Anorexia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Lymphocyte count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Anorexia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anemia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 or 5 Any Serious Adverse Event | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Neutrophil count decreased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Non-serious Platelet count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Fatigue | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Atrial fibrillation | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious White blood cell decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Weight loss | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Non-serious Neutrophil count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Platelet count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 White blood cell decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Hypokalemia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-Serious Platelet count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Ejection fraction decreased | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Platelet count decreased | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Ejection fraction decreased | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Hypokalemia | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Weight loss | 1 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Non-serious Neutrophil count decreased | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 or 5 Any Serious Adverse Event | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Anorexia | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Non-serious Platelet count decreased | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 White blood cell decreased | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Atrial fibrillation | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Neutrophil count decreased | 1 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anemia | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-Serious Platelet count decreased | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious White blood cell decreased | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Lymphocyte count decreased | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Fatigue | 1 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Neutrophil count decreased | 1 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Non-serious Neutrophil count decreased | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 or 5 Any Serious Adverse Event | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Atrial fibrillation | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious White blood cell decreased | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Ejection fraction decreased | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Fatigue | 1 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Anorexia | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Weight loss | 1 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Hypokalemia | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Non-serious Platelet count decreased | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Lymphocyte count decreased | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anemia | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Platelet count decreased | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 White blood cell decreased | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-Serious Platelet count decreased | 1 adverse events |
Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Treatment emergent grades 3, 4, and/or 5 adverse events possibly related grouped by relationship to the study drug (e.g., lenalidomide, romidepsin, CC-486 (5-azacitidine) in any combinations) assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life threatening. Grade 5 is death related to adverse event.
Time frame: 6 cycles (each cycle is 28 days)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Aspartate aminotransferase increased | 1 adverse events |
| All Participants | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anemia | 1 adverse events |
| All Participants | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Alanine aminotransferase increased | 0 adverse events |
| All Participants | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 CPK increased | 0 adverse events |
| All Participants | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Hepatobiliary disorders - Other specify, Drug-Induced liver injury | 1 adverse events |
| All Participants | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 White blood cell decreased | 3 adverse events |
| All Participants | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Platelet count decreased | 1 adverse events |
| All Participants | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Neutrophil count decreased | 3 adverse events |
| All Participants | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Rhabdomyolysis | 2 adverse events |
| All Participants | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Blood bilirubin increased | 1 adverse events |
| All Participants | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Lymphocyte count decreased | 4 adverse events |
| All Participants | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Hypotension | 1 adverse events |
| All Participants | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Any Grade 4 and/or 5 Serious Adverse Event | 0 adverse events |
| All Participants | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Fatigue | 1 adverse events |
| All Participants | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious CPK increased | 0 adverse events |
| All Participants | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Blood bilirubin increased | 1 adverse events |
| All Participants | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Acute kidney injury | 1 adverse events |
| All Participants | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Lymphocyte count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Acute kidney injury | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anemia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Lymphocyte count decreased | 4 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Alanine aminotransferase increased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious CPK increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 CPK increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Hypotension | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 White blood cell decreased | 3 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Aspartate aminotransferase increased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Hepatobiliary disorders - Other specify, Drug-Induced liver injury | 1 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Blood bilirubin increased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Fatigue | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Platelet count decreased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Blood bilirubin increased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Neutrophil count decreased | 3 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Any Grade 4 and/or 5 Serious Adverse Event | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Lymphocyte count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Rhabdomyolysis | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Rhabdomyolysis | 2 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Blood bilirubin increased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Hepatobiliary disorders - Other specify, Drug-Induced liver injury | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Any Grade 4 and/or 5 Serious Adverse Event | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Acute kidney injury | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Alanine aminotransferase increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anemia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Aspartate aminotransferase increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Blood bilirubin increased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious CPK increased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Fatigue | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Hypotension | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Lymphocyte count decreased | 4 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Neutrophil count decreased | 3 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Platelet count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 White blood cell decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 CPK increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Lymphocyte count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 CPK increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 White blood cell decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Platelet count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Acute kidney injury | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Hepatobiliary disorders - Other specify, Drug-Induced liver injury | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Blood bilirubin increased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious CPK increased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Aspartate aminotransferase increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Any Grade 4 and/or 5 Serious Adverse Event | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Fatigue | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Alanine aminotransferase increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Blood bilirubin increased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Hypotension | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Rhabdomyolysis | 2 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Lymphocyte count decreased | 4 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anemia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Lymphocyte count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Neutrophil count decreased | 3 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Alanine aminotransferase increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Blood bilirubin increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Acute kidney injury | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anemia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 White blood cell decreased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Hepatobiliary disorders - Other specify, Drug-Induced liver injury | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Lymphocyte count decreased | 2 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Hypotension | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Platelet count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Fatigue | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Rhabdomyolysis | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Aspartate aminotransferase increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Lymphocyte count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Neutrophil count decreased | 2 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Blood bilirubin increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious CPK increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Any Grade 4 and/or 5 Serious Adverse Event | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 CPK increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Lymphocyte count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Acute kidney injury | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious CPK increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 White blood cell decreased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Alanine aminotransferase increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Blood bilirubin increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Fatigue | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Aspartate aminotransferase increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Rhabdomyolysis | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Any Grade 4 and/or 5 Serious Adverse Event | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Neutrophil count decreased | 2 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Hepatobiliary disorders - Other specify, Drug-Induced liver injury | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Platelet count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Hypotension | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Lymphocyte count decreased | 2 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anemia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Blood bilirubin increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 CPK increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Neutrophil count decreased | 2 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Aspartate aminotransferase increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Any Grade 4 and/or 5 Serious Adverse Event | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 CPK increased | 2 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Blood bilirubin increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious CPK increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Fatigue | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Rhabdomyolysis | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Hypotension | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Lymphocyte count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Hepatobiliary disorders - Other specify, Drug-Induced liver injury | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anemia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Platelet count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 White blood cell decreased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Blood bilirubin increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Lymphocyte count decreased | 2 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Alanine aminotransferase increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Acute kidney injury | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 CPK increased | 2 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 White blood cell decreased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Blood bilirubin increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Lymphocyte count decreased | 2 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Any Grade 4 and/or 5 Serious Adverse Event | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Acute kidney injury | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Hypotension | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Fatigue | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Rhabdomyolysis | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious CPK increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Aspartate aminotransferase increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Alanine aminotransferase increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anemia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Blood bilirubin increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Platelet count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Neutrophil count decreased | 2 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Serious Hepatobiliary disorders - Other specify, Drug-Induced liver injury | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Lymphocyte count decreased | 0 adverse events |
Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Treatment emergent grades 3, 4, and/or 5 adverse events possibly related grouped by relationship to the study drug (e.g., lenalidomide, romidepsin, CC-486 (5-azacitidine) in any combinations) assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life threatening. Grade 5 is death related to adverse event.
Time frame: 6 cycles (each cycle is 28 days)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Neutrophil count decreased | 0 adverse events |
| All Participants | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Platelet count decreased | 0 adverse events |
| All Participants | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anorexia | 0 adverse events |
| All Participants | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Any Grade 3, 4, and/or 5 Serious Adverse Event | 0 adverse events |
| All Participants | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Hypokalemia | 0 adverse events |
| All Participants | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anemia | 1 adverse events |
| All Participants | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Platelet count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anemia | 1 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Hypokalemia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Any Grade 3, 4, and/or 5 Serious Adverse Event | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Neutrophil count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anorexia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Platelet count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Platelet count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Platelet count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Platelet count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anemia | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Any Grade 3, 4, and/or 5 Serious Adverse Event | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Neutrophil count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anorexia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Hypokalemia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Hypokalemia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Platelet count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Any Grade 3, 4, and/or 5 Serious Adverse Event | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anemia | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Platelet count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Neutrophil count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anorexia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Neutrophil count decreased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Hypokalemia | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anorexia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Platelet count decreased | 3 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Platelet count decreased | 4 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Any Grade 3, 4, and/or 5 Serious Adverse Event | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anemia | 7 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anorexia | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Any Grade 3, 4, and/or 5 Serious Adverse Event | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Neutrophil count decreased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anemia | 7 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Platelet count decreased | 3 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Platelet count decreased | 4 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Hypokalemia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Hypokalemia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Any Grade 3, 4, and/or 5 Serious Adverse Event | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anemia | 7 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anorexia | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Platelet count decreased | 4 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Neutrophil count decreased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Platelet count decreased | 3 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Neutrophil count decreased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Hypokalemia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Platelet count decreased | 3 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Any Grade 3, 4, and/or 5 Serious Adverse Event | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Platelet count decreased | 4 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anorexia | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anemia | 7 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Any Grade 3, 4, and/or 5 Serious Adverse Event | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anemia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Neutrophil count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Hypokalemia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Platelet count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Platelet count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anorexia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Hypokalemia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anorexia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Platelet count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Platelet count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anemia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Neutrophil count decreased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Any Grade 3, 4, and/or 5 Serious Adverse Event | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anemia | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Any Grade 3, 4, and/or 5 Serious Adverse Event | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Platelet count decreased | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anorexia | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Hypokalemia | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Platelet count decreased | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Neutrophil count decreased | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Hypokalemia | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Neutrophil count decreased | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Any Grade 3, 4, and/or 5 Serious Adverse Event | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anorexia | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Non-serious Anemia | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 3 Platelet count decreased | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination | Grade 4 Platelet count decreased | 0 adverse events |
Maximum Tolerated Dose (MTD)
The MTD is the dose level at which no more than 1 of up to 6 participants experience dose-limiting toxicity (DLT) during the DLT evaluation window(s), or the dose below that at which at least 2 (of ≤6) participants have DLT. A DLT is defined as any treatment-emergent and related severe (grade ≥3) toxicity related to lenalidomide, romidepsin and/or CC-486 (5-azacitidine) and occurring during the maximum tolerated dose (MTD) observation time, defined as day -7 until end of cycle 1 (normally day 22).
Time frame: 21 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Maximum Tolerated Dose (MTD) | 20 mg/day |
Number of Treatment Emergent Grades 3, 4 and/or 5 Adverse Events Possibly Related to Drug Grouped by Severity
Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.
Time frame: 6 cycles (each cycle is 28 days)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Number of Treatment Emergent Grades 3, 4 and/or 5 Adverse Events Possibly Related to Drug Grouped by Severity | Grade 4 | 4 adverse events |
| All Participants | Number of Treatment Emergent Grades 3, 4 and/or 5 Adverse Events Possibly Related to Drug Grouped by Severity | Grade 3 | 13 adverse events |
| All Participants | Number of Treatment Emergent Grades 3, 4 and/or 5 Adverse Events Possibly Related to Drug Grouped by Severity | Grade 5 | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Number of Treatment Emergent Grades 3, 4 and/or 5 Adverse Events Possibly Related to Drug Grouped by Severity | Grade 5 | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Number of Treatment Emergent Grades 3, 4 and/or 5 Adverse Events Possibly Related to Drug Grouped by Severity | Grade 4 | 2 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Number of Treatment Emergent Grades 3, 4 and/or 5 Adverse Events Possibly Related to Drug Grouped by Severity | Grade 3 | 9 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Number of Treatment Emergent Grades 3, 4 and/or 5 Adverse Events Possibly Related to Drug Grouped by Severity | Grade 3 | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Number of Treatment Emergent Grades 3, 4 and/or 5 Adverse Events Possibly Related to Drug Grouped by Severity | Grade 5 | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Number of Treatment Emergent Grades 3, 4 and/or 5 Adverse Events Possibly Related to Drug Grouped by Severity | Grade 4 | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Number of Treatment Emergent Grades 3, 4 and/or 5 Adverse Events Possibly Related to Drug Grouped by Severity | Grade 4 | 4 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Number of Treatment Emergent Grades 3, 4 and/or 5 Adverse Events Possibly Related to Drug Grouped by Severity | Grade 3 | 4 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Number of Treatment Emergent Grades 3, 4 and/or 5 Adverse Events Possibly Related to Drug Grouped by Severity | Grade 5 | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Number of Treatment Emergent Grades 3, 4 and/or 5 Adverse Events Possibly Related to Drug Grouped by Severity | Grade 3 | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Number of Treatment Emergent Grades 3, 4 and/or 5 Adverse Events Possibly Related to Drug Grouped by Severity | Grade 5 | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Number of Treatment Emergent Grades 3, 4 and/or 5 Adverse Events Possibly Related to Drug Grouped by Severity | Grade 4 | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Number of Treatment Emergent Grades 3, 4 and/or 5 Adverse Events Possibly Related to Drug Grouped by Severity | Grade 4 | 4 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Number of Treatment Emergent Grades 3, 4 and/or 5 Adverse Events Possibly Related to Drug Grouped by Severity | Grade 5 | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Number of Treatment Emergent Grades 3, 4 and/or 5 Adverse Events Possibly Related to Drug Grouped by Severity | Grade 3 | 4 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Number of Treatment Emergent Grades 3, 4 and/or 5 Adverse Events Possibly Related to Drug Grouped by Severity | Grade 3 | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Number of Treatment Emergent Grades 3, 4 and/or 5 Adverse Events Possibly Related to Drug Grouped by Severity | Grade 4 | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Number of Treatment Emergent Grades 3, 4 and/or 5 Adverse Events Possibly Related to Drug Grouped by Severity | Grade 5 | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Number of Treatment Emergent Grades 3, 4 and/or 5 Adverse Events Possibly Related to Drug Grouped by Severity | Grade 4 | 3 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Number of Treatment Emergent Grades 3, 4 and/or 5 Adverse Events Possibly Related to Drug Grouped by Severity | Grade 3 | 4 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Number of Treatment Emergent Grades 3, 4 and/or 5 Adverse Events Possibly Related to Drug Grouped by Severity | Grade 5 | 0 adverse events |
Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity
Rate and severity of AEs will be summarized by grade and type of toxicity. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.
Time frame: 6 cycles (each cycle is 28 days)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Adrenal insufficiency | 0 adverse events |
| All Participants | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Hepatobiliary disorders - Other specify, Drug-Induced liver injury | 0 adverse events |
| All Participants | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Fatigue | 0 adverse events |
| All Participants | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Rhabdomyolysis | 0 adverse events |
| All Participants | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 1 Heart failure | 0 adverse events |
| All Participants | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Anemia | 0 adverse events |
| All Participants | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Atrial fibrillation | 0 adverse events |
| All Participants | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Blood bilirubin increased | 0 adverse events |
| All Participants | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 1 Hypotension | 0 adverse events |
| All Participants | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Anorexia | 0 adverse events |
| All Participants | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Neoplasms benign, malignant&unspecified(incl cysts&polyps)Other specify tumor flare reaction | 0 adverse events |
| All Participants | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Vomiting | 0 adverse events |
| All Participants | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Nausea | 0 adverse events |
| All Participants | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 4 Adrenal insufficiency | 0 adverse events |
| All Participants | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Pain in extremity | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Blood bilirubin increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Neoplasms benign, malignant&unspecified(incl cysts&polyps)Other specify tumor flare reaction | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 4 Adrenal insufficiency | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Nausea | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Fatigue | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Anemia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 1 Hypotension | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Rhabdomyolysis | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Adrenal insufficiency | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Vomiting | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 1 Heart failure | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Anorexia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Atrial fibrillation | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Hepatobiliary disorders - Other specify, Drug-Induced liver injury | 0 adverse events |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Pain in extremity | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Vomiting | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Blood bilirubin increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Anemia | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 4 Adrenal insufficiency | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 1 Hypotension | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Atrial fibrillation | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Pain in extremity | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Rhabdomyolysis | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Fatigue | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Adrenal insufficiency | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 1 Heart failure | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Neoplasms benign, malignant&unspecified(incl cysts&polyps)Other specify tumor flare reaction | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Anorexia | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Nausea | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Hepatobiliary disorders - Other specify, Drug-Induced liver injury | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Vomiting | 3 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Rhabdomyolysis | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 1 Heart failure | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Hepatobiliary disorders - Other specify, Drug-Induced liver injury | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Pain in extremity | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Atrial fibrillation | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Blood bilirubin increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Nausea | 2 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Anemia | 4 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 1 Hypotension | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Adrenal insufficiency | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 4 Adrenal insufficiency | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Anorexia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Fatigue | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Neoplasms benign, malignant&unspecified(incl cysts&polyps)Other specify tumor flare reaction | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Rhabdomyolysis | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Anorexia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 4 Adrenal insufficiency | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 1 Hypotension | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Fatigue | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Hepatobiliary disorders - Other specify, Drug-Induced liver injury | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Nausea | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Blood bilirubin increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Vomiting | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 1 Heart failure | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Neoplasms benign, malignant&unspecified(incl cysts&polyps)Other specify tumor flare reaction | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Adrenal insufficiency | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Pain in extremity | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Atrial fibrillation | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Anemia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 1 Hypotension | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Atrial fibrillation | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Hepatobiliary disorders - Other specify, Drug-Induced liver injury | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Fatigue | 3 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Pain in extremity | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Anemia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Rhabdomyolysis | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Vomiting | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Blood bilirubin increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Anorexia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Neoplasms benign, malignant&unspecified(incl cysts&polyps)Other specify tumor flare reaction | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Nausea | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 4 Adrenal insufficiency | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 1 Heart failure | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Adrenal insufficiency | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Blood bilirubin increased | 2 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Nausea | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Adrenal insufficiency | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Hepatobiliary disorders - Other specify, Drug-Induced liver injury | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Anorexia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Neoplasms benign, malignant&unspecified(incl cysts&polyps)Other specify tumor flare reaction | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Fatigue | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Rhabdomyolysis | 2 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Pain in extremity | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 1 Heart failure | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Atrial fibrillation | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Anemia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 1 Hypotension | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 4 Adrenal insufficiency | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Vomiting | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Adrenal insufficiency | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Fatigue | 4 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Blood bilirubin increased | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Vomiting | 5 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Anemia | 7 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Neoplasms benign, malignant&unspecified(incl cysts&polyps)Other specify tumor flare reaction | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Nausea | 6 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 4 Adrenal insufficiency | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Rhabdomyolysis | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 1 Hypotension | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Atrial fibrillation | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Anorexia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Hepatobiliary disorders - Other specify, Drug-Induced liver injury | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Pain in extremity | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 1 Heart failure | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Anemia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 1 Heart failure | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 1 Hypotension | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Fatigue | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Nausea | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Vomiting | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Neoplasms benign, malignant&unspecified(incl cysts&polyps)Other specify tumor flare reaction | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Pain in extremity | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Anorexia | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Atrial fibrillation | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Adrenal insufficiency | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Blood bilirubin increased | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Hepatobiliary disorders - Other specify, Drug-Induced liver injury | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Rhabdomyolysis | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 4 Adrenal insufficiency | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Pain in extremity | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 1 Heart failure | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Anemia | 6 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Atrial fibrillation | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Fatigue | 5 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Neoplasms benign, malignant&unspecified(incl cysts&polyps)Other specify tumor flare reaction | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Hepatobiliary disorders - Other specify, Drug-Induced liver injury | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Nausea | 3 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Rhabdomyolysis | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Vomiting | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 4 Adrenal insufficiency | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Anorexia | 1 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Adrenal insufficiency | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 1 Hypotension | 0 adverse events |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Blood bilirubin increased | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Rhabdomyolysis | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Fatigue | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Hepatobiliary disorders - Other specify, Drug-Induced liver injury | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Pain in extremity | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 4 Adrenal insufficiency | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Atrial fibrillation | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Anorexia | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 1 Heart failure | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Neoplasms benign, malignant&unspecified(incl cysts&polyps)Other specify tumor flare reaction | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Adrenal insufficiency | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Vomiting | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Blood bilirubin increased | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Anemia | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 1 Hypotension | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Nausea | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Pain in extremity | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Hepatobiliary disorders - Other specify, Drug-Induced liver injury | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Fatigue | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Nausea | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Rhabdomyolysis | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Adrenal insufficiency | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Vomiting | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 1 Hypotension | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Blood bilirubin increased | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 1 Heart failure | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Anemia | 3 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Anorexia | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 4 Adrenal insufficiency | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Neoplasms benign, malignant&unspecified(incl cysts&polyps)Other specify tumor flare reaction | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Atrial fibrillation | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Blood bilirubin increased | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Anorexia | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Pain in extremity | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Adrenal insufficiency | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Anemia | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Rhabdomyolysis | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Vomiting | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Hepatobiliary disorders - Other specify, Drug-Induced liver injury | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 1 Hypotension | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Nausea | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 4 Adrenal insufficiency | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Fatigue | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Atrial fibrillation | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 1 Heart failure | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Neoplasms benign, malignant&unspecified(incl cysts&polyps)Other specify tumor flare reaction | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 4 Adrenal insufficiency | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Anorexia | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Pain in extremity | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Atrial fibrillation | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Neoplasms benign, malignant&unspecified(incl cysts&polyps)Other specify tumor flare reaction | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Vomiting | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Adrenal insufficiency | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Nausea | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Blood bilirubin increased | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Fatigue | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Hepatobiliary disorders - Other specify, Drug-Induced liver injury | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 1 Hypotension | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Rhabdomyolysis | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 1 Heart failure | 0 adverse events |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Anemia | 0 adverse events |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Nausea | 0 adverse events |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 1 Heart failure | 0 adverse events |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 1 Hypotension | 0 adverse events |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Neoplasms benign, malignant&unspecified(incl cysts&polyps)Other specify tumor flare reaction | 0 adverse events |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Pain in extremity | 0 adverse events |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Atrial fibrillation | 0 adverse events |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Adrenal insufficiency | 0 adverse events |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Blood bilirubin increased | 0 adverse events |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Rhabdomyolysis | 0 adverse events |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Anemia | 0 adverse events |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Anorexia | 0 adverse events |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Hepatobiliary disorders - Other specify, Drug-Induced liver injury | 0 adverse events |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 4 Adrenal insufficiency | 0 adverse events |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Vomiting | 0 adverse events |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Fatigue | 0 adverse events |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 1 Heart failure | 0 adverse events |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Fatigue | 0 adverse events |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Blood bilirubin increased | 0 adverse events |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Nausea | 0 adverse events |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Adrenal insufficiency | 0 adverse events |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Pain in extremity | 0 adverse events |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Rhabdomyolysis | 0 adverse events |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 1 Hypotension | 0 adverse events |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Anorexia | 0 adverse events |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Atrial fibrillation | 0 adverse events |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Neoplasms benign, malignant&unspecified(incl cysts&polyps)Other specify tumor flare reaction | 0 adverse events |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 4 Adrenal insufficiency | 0 adverse events |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Anemia | 0 adverse events |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 3 Hepatobiliary disorders - Other specify, Drug-Induced liver injury | 0 adverse events |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's | Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity | Grade 2 Vomiting | 0 adverse events |
Complete Response Rate (CRR)
CRR will be estimated using the Kaplan-Meier curve and reported along with a 95% confidence interval. Response was measured by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria. Complete response (CR) is disappearance of all target lesions and all nodes with long axis \<10mm.
Time frame: 6 cycles (each cycle is 28 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Complete Response Rate (CRR) | 0 percentage of participants |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Complete Response Rate (CRR) | 16.6 percentage of participants |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Complete Response Rate (CRR) | 0 percentage of participants |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Complete Response Rate (CRR) | 0 percentage of participants |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Complete Response Rate (CRR) | 0 percentage of participants |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Complete Response Rate (CRR) | 0 percentage of participants |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Complete Response Rate (CRR) | 100 percentage of participants |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Complete Response Rate (CRR) | 50 percentage of participants |
Duration of Response (DOR) in Months Reported Along With a 95% Confidence Interval
DOR will be determined and reported along with a 95% confidence interval. DOR is measured from the time measurement criteria are met for complete response (CR) or partial response (PR (whichever is recorded first) until the first date that recurrent or progressive disease is objectively documented. Response was measured by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria. Complete response (CR) is disappearance of all target lesions and all nodes with long axis \<10mm. Partial response (PR) is a ≥30% decrease in the sum of longest diameters of target lesions but not a CR. Progressive disease is \>20% increase in the sum of longest diameters of target lesions.
Time frame: up to a median of 11.7 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Participants | Duration of Response (DOR) in Months Reported Along With a 95% Confidence Interval | 5.8 Months |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Duration of Response (DOR) in Months Reported Along With a 95% Confidence Interval | NA Months |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Duration of Response (DOR) in Months Reported Along With a 95% Confidence Interval | NA Months |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Duration of Response (DOR) in Months Reported Along With a 95% Confidence Interval | 2.1 Months |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Duration of Response (DOR) in Months Reported Along With a 95% Confidence Interval | 6.0 Months |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Duration of Response (DOR) in Months Reported Along With a 95% Confidence Interval | 3.4 Months |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Duration of Response (DOR) in Months Reported Along With a 95% Confidence Interval | 11.7 Months |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Duration of Response (DOR) in Months Reported Along With a 95% Confidence Interval | 1.5 Months |
Overall Response Rate (Complete Response + Partial Response)
The response rate will be estimated using the Kaplan-Meier curve and reported along with a 95% confidence interval. Response was measured by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria. Complete response (CR) is disappearance of all target lesions and all nodes with long axis \<10mm. Partial response (PR) is a ≥30% decrease in the sum of longest diameters of target lesions but not a CR.
Time frame: 6 cycles (each cycle is 28 days)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Overall Response Rate (Complete Response + Partial Response) | Partial Response | 50 percentage of participants |
| All Participants | Overall Response Rate (Complete Response + Partial Response) | Complete Response | 50 percentage of participants |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Overall Response Rate (Complete Response + Partial Response) | Complete Response | 16.6 percentage of participants |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Overall Response Rate (Complete Response + Partial Response) | Partial Response | 0 percentage of participants |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Overall Response Rate (Complete Response + Partial Response) | Complete Response | 33.3 percentage of participants |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Overall Response Rate (Complete Response + Partial Response) | Partial Response | 33.3 percentage of participants |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Overall Response Rate (Complete Response + Partial Response) | Complete Response | 66 percentage of participants |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Overall Response Rate (Complete Response + Partial Response) | Partial Response | 66 percentage of participants |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Overall Response Rate (Complete Response + Partial Response) | Partial Response | 100 percentage of participants |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Overall Response Rate (Complete Response + Partial Response) | Complete Response | 100 percentage of participants |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Overall Response Rate (Complete Response + Partial Response) | Complete Response | 50 percentage of participants |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Overall Response Rate (Complete Response + Partial Response) | Partial Response | 50 percentage of participants |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Overall Response Rate (Complete Response + Partial Response) | Complete Response | 100 percentage of participants |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Overall Response Rate (Complete Response + Partial Response) | Partial Response | 0 percentage of participants |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Overall Response Rate (Complete Response + Partial Response) | Partial Response | 50 percentage of participants |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Overall Response Rate (Complete Response + Partial Response) | Complete Response | 100 percentage of participants |
Overall Survival (OS)
OS will be estimated using the Kaplan-Meier curve and reported along with a 95% confidence interval. OS is defined as the time from the date of study enrollment until time of death from any cause.
Time frame: up to a median of 8.7 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Participants | Overall Survival (OS) | 8.7 Months |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Overall Survival (OS) | 4.6 Months |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Overall Survival (OS) | NA Months |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Overall Survival (OS) | NA Months |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Overall Survival (OS) | NA Months |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Overall Survival (OS) | 4.5 Months |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Overall Survival (OS) | NA Months |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Overall Survival (OS) | NA Months |
Progression-free Survival (PFS) in Months Reported Along With a 95% Confidence Interval
PFS will be estimated using the Kaplan-Meier curve and reported along with a 95% confidence interval. PFS is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, or death, whichever occurs first measured by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria. Progressive disease is \>20% increase in the sum of longest diameters of target lesions. Disease relapse is defined as new areas of disease or \>50% increase in growth of target lesion.
Time frame: up to a median of 13.1 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Participants | Progression-free Survival (PFS) in Months Reported Along With a 95% Confidence Interval | 5.3 Months |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Progression-free Survival (PFS) in Months Reported Along With a 95% Confidence Interval | 1.7 Months |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Progression-free Survival (PFS) in Months Reported Along With a 95% Confidence Interval | NA Months |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Progression-free Survival (PFS) in Months Reported Along With a 95% Confidence Interval | 3.7 Months |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Progression-free Survival (PFS) in Months Reported Along With a 95% Confidence Interval | 9.2 Months |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Progression-free Survival (PFS) in Months Reported Along With a 95% Confidence Interval | 3.6 Months |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Progression-free Survival (PFS) in Months Reported Along With a 95% Confidence Interval | 13.1 Months |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Progression-free Survival (PFS) in Months Reported Along With a 95% Confidence Interval | 3.4 Months |
Number of Participants With a Dose-limiting Toxicity (DLT)
A DLT is defined as any treatment-emergent and related severe (grade ≥3) toxicity related to lenalidomide, romidepsin and/or CC-486 (5-azacitidine) and occurring during the maximum tolerated dose (MTD) observation time, defined as day -7 until end of cycle 1 (normally day 22). Grade 4 is life threatening, and Grade 5 is death related to adverse event. Serious toxicity was assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).
Time frame: Day -7 until end of cycle 1 (normally day 22)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants With a Dose-limiting Toxicity (DLT) | Grade 3 | 0 Participants |
| All Participants | Number of Participants With a Dose-limiting Toxicity (DLT) | Grade 5 | 0 Participants |
| All Participants | Number of Participants With a Dose-limiting Toxicity (DLT) | Grade 4 | 1 Participants |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Number of Participants With a Dose-limiting Toxicity (DLT) | Grade 5 | 0 Participants |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Number of Participants With a Dose-limiting Toxicity (DLT) | Grade 4 | 1 Participants |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Number of Participants With a Dose-limiting Toxicity (DLT) | Grade 3 | 0 Participants |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Number of Participants With a Dose-limiting Toxicity (DLT) | Grade 5 | 0 Participants |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Number of Participants With a Dose-limiting Toxicity (DLT) | Grade 3 | 0 Participants |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Number of Participants With a Dose-limiting Toxicity (DLT) | Grade 4 | 0 Participants |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Number of Participants With a Dose-limiting Toxicity (DLT) | Grade 3 | 00 Participants |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Number of Participants With a Dose-limiting Toxicity (DLT) | Grade 4 | 0 Participants |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Number of Participants With a Dose-limiting Toxicity (DLT) | Grade 5 | 0 Participants |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Number of Participants With a Dose-limiting Toxicity (DLT) | Grade 4 | 0 Participants |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Number of Participants With a Dose-limiting Toxicity (DLT) | Grade 3 | 0 Participants |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Number of Participants With a Dose-limiting Toxicity (DLT) | Grade 5 | 0 Participants |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Number of Participants With a Dose-limiting Toxicity (DLT) | Grade 4 | 0 Participants |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Number of Participants With a Dose-limiting Toxicity (DLT) | Grade 3 | 0 Participants |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Number of Participants With a Dose-limiting Toxicity (DLT) | Grade 5 | 0 Participants |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Number of Participants With a Dose-limiting Toxicity (DLT) | Grade 4 | 0 Participants |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Number of Participants With a Dose-limiting Toxicity (DLT) | Grade 3 | 0 Participants |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Number of Participants With a Dose-limiting Toxicity (DLT) | Grade 5 | 0 Participants |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Number of Participants With a Dose-limiting Toxicity (DLT) | Grade 3 | 0 Participants |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Number of Participants With a Dose-limiting Toxicity (DLT) | Grade 4 | 0 Participants |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Number of Participants With a Dose-limiting Toxicity (DLT) | Grade 5 | 0 Participants |
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time frame: up to 3.5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | 2 Participants |
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | 6 Participants |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | 6 Participants |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | 3 Participants |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | 3 Participants |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | 2 Participants |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | 1 Participants |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | 3 Participants |