Relapsed or refractory multiple myeloma (RRMM) and newly diagnosed MM (NDMM) MedDRA version: 21.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 16.1 Level: HLT Classification code 10028229 Term: Multiple myelomas System Organ Class: 100000004851
Conditions
Interventions
Product Name: CC-92480 0.1 mg
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: mezigdomide
CAS Number: 2259648-80-9
Current Sponsor code: CC-92480
Concentration unit: mg milligram(s)
Concentrat
Sponsors
Celgene Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is = 18 years of age at the time of signing the informed consent form (ICF). 2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted. 3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements. 4. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2. 5. Females of childbearing potential (FCBP) must agree and adhere to all testing and contraception requirements in the mezigdomide Global Pregnancy Prevention Plan (PPP). Duration of contraception for FCBP must be in accordance with the mezigdomide Global PPP, or 7 months after the last dose of BTZ (for Cohorts A, D and G), 90 days after the last dose of DARA (for Cohorts B and E), 6 months after the last dose of CFZ or ELO (for Cohorts C and F and Cohorts H and J), or 5 months after the last dose of ISA (for Cohorts I and K), whichever is later. 6. Male subjects must agree and adhere to all requirements in the mezigdomide Global PPP. Duration of contraception for male subjects must be in accordance with the mezigdomide Global PPP, or 3 months after the last dose of DARA (for Cohorts B and E), CFZ (for Cohorts C and F) and ISA (for Cohorts I and K), 4 months after the last dose of BTZ (for Cohorts A, D and G), or 6 months after the last dose of elotuzumab, whichever is longer, even if the subject has undergone a successful vasectomy. 7. Male subjects must agree to refrain from donating sperm or semen in accordance with the mezigdomide Global PPP, or for at least 3 months after the last dose of DARA, CFZ and ISA, 4 months after the last dose of BTZ or 6 months after the last dose of elotuzumab, whichever is later. Females must refrain from egg cell (ova) donation in accordance with the mezigdomide Global PPP. 8. All subjects must agree to refrain from donating blood while on study treatment and for 28 days after the last dose of study treatment. 9. All male and female subjects must also follow all other requirements defined in the mezigdomide Global PPP. Please refer to protocol (Sec 4.2) for additional inclusion criteria. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 255 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 169
Exclusion criteria
Exclusion criteria: 1. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. 2. Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study. 3. Subject has any condition that confounds the ability to interpret data from the study. 4. Subject has any of the following laboratory abnormalities: a. Absolute neutrophil count (ANC) 13.5 mg/dL (> 3.4 mmol/L) f. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 x ULN g. Serum total bilirubin > 1.5 x ULN or > 3.0 mg/dL for subjects with documented Gilbert’s syndrome h. Prothrombin time (PT)/international normalized ration (INR) > 1.5 x ULN or partial thromboplastin time (PTT) > 1.5 x ULN, (for subjects not receiving therapeutic anticoagulation). 5. Subject has peripheral neuropathy = Grade 2 6. Subject with gastrointestinal disease that may significantly alter the absorption of mezigdomide. 7. Subject has prior history of malignancies, other than MM, unless the subject has been free of the disease for = 5 years with the exception of the following non-invasive malignancies: • Basal cell carcinoma of the skin • Squamous cell carcinoma of the skin • Carcinoma in situ of the cervix • Carcinoma in situ of the breast • Incidental histologic finding of prostate cancer or prostate cancer that is curative 8. Subject has plasma cell leukemia, Waldenstrom’s macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or clinically significant amyloidosis. 9. Subject with known central nervous system (CNS) involvement with myeloma. 10. Subject has received immunosuppressive medication within the last 14 days of initiating study treatment. Please refer to protocol for exceptions to this criterion. 11. Subject has impaired cardiac function or clinically significant cardiac disease, including any of the following: • Left ventricular ejection fraction (LVEF) 470 milliseconds (msec) using Fridericia’s QT correction formula; a history of or current risk factors for torsades de pointe (eg, heart failure, hypokalemia, or a family history of Long QT Syndrome); and concurrent administration of medications that prolong the QT/QTc interval • Congestive heart failure (New York Heart Association Class III or IV). • Myocardial infarction within 12 months prior to starting study treatment. • Unstable or poorly controlled angina pectoris, including the Prinzmetal variant of angina pectoris • History of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, pericardial disease or electrocardiographic ev
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the recommended dose and regimen, and evaluate the safety and preliminary efficacy of mezigdomide in combination with standard treatments in subjects with RRMM and NDMM ;Secondary Objective: Evaluate additional measures of efficacy (time-to-response, duration of response, very good partial response or better and complete response rates) of mezigdomide in combination with standard treatments in subjects with RRMM and NDMM.;Primary end point(s): Recommend Dose and Regimen Review of dose-limiting toxicities (DLTs), safety, and if applicable, pharmacokinetics (PK), pharlmacodynamics (Pd), and/or preliminary efficacy data by the Safety Review Committee (SRC) Safety Type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to study treatment Overall response rate (ORR) Best response = partial response (PR), according to the International Myeloma Working Group (IMWG) Uniform Response Criteria ;Timepoint(s) of evaluation of this end point: Recommend Dose and Regimen Phase I Safety From first subject first visit until 28 days after the last subject discontinues study treatment. Overall response rate (ORR) From first subject enrollment until the last subject is no longer evaluable for response or has progressed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time-to-response (TTR) Time from first dose to the first documentation of response (PR or greater) Duration of response (DOR) Time from the first documentation of response (PR or greater) to the first documentation of progressive disease (PD) or death Complete Response (CR) rate Percentage of subjects who achieved CR or better according to IMWG Uniform Response Criteria Very good partial response (VGPR) rate (Cohorts D and E) Percentage of subjects who achieved VGPR or better according to IMWG Uniform Response Criteria;Timepoint(s) of evaluation of this end point: From first subject enrollment until the last subject is no longer evaluable for response or has progressed. | — |
Countries
Canada, Czechia, Czech Republic, Denmark, France, Germany, Greece, Italy, Spain, United States
Contacts
Public ContactGSM-CT
Bristol-Myers Squibb International Corporation
Outcome results
None listed