Relapsed or Refractory Multiple Myeloma
Conditions
Brief summary
The purpose of this Phase I study of vorinostat in combination with lenalidomide and dexamethasone in participants with relapsed or refractory multiple myeloma is to determine the maximum tolerated dose (MTD) as estimated by the incidence of dose-limiting toxicities (DLTs) and recommended Phase 2 dose (RP2D) as estimated by the incidence of drug-related adverse events (AEs).
Interventions
DRUGVorinostat
Vorinostat 300 mg or 400 mg QD via oral capsule on Days 1-7 and Days 15-21 of each 28-day cycle.
DRUGLenalidomide
Lenalidomide 10 mg, 15 mg, 20 mg or 25 mg QD via oral capsule on Days 1-21 of each 28-day cycle.
DRUGDexamethasone
Dexamethasone 40 mg QD via oral tablet on Days 1, 8, 15 and 22 of each 28-day cycle.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is a male or female at least 18 years old * Has relapsed or refractory MM and has had at least one prior therapy * Female participants of childbearing potential must have 2 negative serum pregnancy tests prior to receiving the first dose of study drugs * Female participants who can become pregnant must agree to use 2 separate forms of effective birth control at the same time, 4 weeks before, while taking, and for 4 weeks after stopping lenalidomide; post menopausal participants should be free from menses for \>2 years, or are surgically sterilized * Male participant agrees to use an adequate method of contraception for the duration of the study, even if the participant has undergone a successful vasectomy * Male participants must agree to use a latex condom during sexual contact with a pregnant female or a female who can become pregnant; this is required for the duration of the study, and for 4 weeks after stopping therapy * Has at least 3 weeks washout prior to treatment * Is able to swallow capsules and is able to take or tolerate oral medications on a continuous basis
Exclusion criteria
* Has prior treatment with a histone deacetylase (HDAC) inhibitor * Has prior allogenetic bone marrow transplant * Has received intravenous antibiotics, antiviral, or antifungal agents within 2 weeks prior to the start of the study drug * Uses illicit drugs, substance abuse or had a recent history (within the last year) of drug or alcohol abuse * Is pregnant or breast feeding or expecting to have a baby during the course of the study * Has human immunodeficiency virus (HIV) infection * Has Hepatitis B/C infection * Is currently receiving treatment for another type of cancer other than skin or cervical cancer that has not been in remission for 5 years or longer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | Cycle 1 (Up to 28 days) | DLTs consisted of hematologic or non-hemtologic toxicities. Hematologic DLT was any grade (gr) 4 neutropenia lasting ≥7 days, gr 4 thrombocytopenia or gr 5 hematologic toxicity. Non-hematologic DLT was any gr 3, 4 or 5 non-hematologic toxicity with the exception of (1) gr 3 nausea, vomiting, diarrhea or dehydration not compliant with medical care, lasting \<48 hours (2) gr 3 acidosis/alkalosis returning to ≤ gr 2 by 48 hours of medical care (3) gr 3 liver function test elevation without symptoms, lasting ≤5 days (4) Gr 3 amylase elevation without symptoms (5) Gr 3 hypocalcemia, hypokalemia, hypomagnesemia, hyponatremia or hyphosphatemia responding to medical care (6) Gr 3 hypercholeresterolemia or hypertriglyceridemia. A drug-related AE causing dose modification of study drug is also considered a DLT. Per protocol DLTs were analyzed in the first 28-day treatment cycle. The number of participants experiencing DLTs is reported here for all participants who got ≥1 dose of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Drug-Related Adverse Events (AEs) | Up to ~55 months (through pre-specified final statistical analysis cut-off date of 3-Sep-2012) | An AE was defined as any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the Sponsor's product is also an AE. An AE was considered related to a drug as determined by the investigator based on exposure (evidence of exposure to drug), time course (time of AE onset versus drug-induced effect), likely cause (AE etiology related or un-related to drug), de-challenge (drug dose reduction/discontinuation) or re-challenge (drug re-exposure). Per protocol participants experiencing drug-related AEs were analyzed at the time of the protocol-specified final statistical analysis with a 3-September (Sep)-2012 data cut-off. The number of participants experiencing drug-related AEs is reported here for all participants who got ≥1 dose of study drug. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | Up to ~55 months (through pre-specified final statistical analysis cut-off date of 3-Sep-2012) | Best overall tumor response consisted of CR (negative M-protein immunofixation \[IF\], \<5% bone marrow \[BM\] plasma cells, no soft tissue plasmacytomas \[STP\]), NCR (positive M-protein IF, \<5% BM plasma cells, no STP), VGPR (≥90% M-protein decrease, \<5% BM plasma cells, no STP), PR (≥50% M-protein, BM plasma cells, STP decrease), MR (25-49% M-protein, BM plasma cells, STP decrease), SD (\<25% decrease-25% increase in M-protein, BM plasma cells; \<25% decrease-increase in definite STP) or PD (≥25% M-protein, BM plasma cells increase; new STP, lesions). Per protocol participants experiencing best overall response by CR, NCR, VGPR, PR, MR, SD or PD were analyzed as a single prespecified analysis at the time of protocol-specified final statistical analysis with a 3-Sep-2012 data cut-off. The number of participants experiencing best overall response by CR, NCR, VGPR, PR, MR, SD or PD is reported here for all participants who got ≥1 dose of study drug and had a post baseline efficacy assessment. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Level 1: Vorinostat 300 mg + Lenalidomide 10 mg Participants received vorinostat 300 mg orally once-daily (QD) on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles. | 4 |
| Level 2: Vorinostat 400 mg + Lenalidomide 10 mg Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles. | 4 |
| Level 3: Vorinostat 400 mg + Lenalidomide 15 mg Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 15 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles. | 3 |
| Level 4: Vorinostat 400 mg + Lenalidomide 20 mg Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 20 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles. | 3 |
| Level 5: Vorinostat 400 mg + Lenalidomide 25 mg Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 25 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle. Treatment continued until progressive disease or unacceptable toxicity. | 17 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 0 | 0 | 6 |
| Overall Study | Progressive Disease | 3 | 3 | 3 | 3 | 9 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Level 1: Vorinostat 300 mg + Lenalidomide 10 mg | Level 2: Vorinostat 400 mg + Lenalidomide 10 mg | Level 3: Vorinostat 400 mg + Lenalidomide 15 mg | Level 4: Vorinostat 400 mg + Lenalidomide 20 mg | Level 5: Vorinostat 400 mg + Lenalidomide 25 mg | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 69.5 Years STANDARD_DEVIATION 4.7 | 58.5 Years STANDARD_DEVIATION 2.1 | 66.3 Years STANDARD_DEVIATION 6.1 | 55.7 Years STANDARD_DEVIATION 2.5 | 64.1 Years STANDARD_DEVIATION 7.2 | 63.5 Years STANDARD_DEVIATION 7 |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 7 Participants | 13 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 1 Participants | 2 Participants | 10 Participants | 18 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 1 / 4 | 0 / 3 | 0 / 3 | 3 / 17 |
| other Total, other adverse events | 4 / 4 | 4 / 4 | 3 / 3 | 3 / 3 | 17 / 17 |
| serious Total, serious adverse events | 2 / 4 | 1 / 4 | 1 / 3 | 2 / 3 | 8 / 17 |
Outcome results
Primary
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
DLTs consisted of hematologic or non-hemtologic toxicities. Hematologic DLT was any grade (gr) 4 neutropenia lasting ≥7 days, gr 4 thrombocytopenia or gr 5 hematologic toxicity. Non-hematologic DLT was any gr 3, 4 or 5 non-hematologic toxicity with the exception of (1) gr 3 nausea, vomiting, diarrhea or dehydration not compliant with medical care, lasting \<48 hours (2) gr 3 acidosis/alkalosis returning to ≤ gr 2 by 48 hours of medical care (3) gr 3 liver function test elevation without symptoms, lasting ≤5 days (4) Gr 3 amylase elevation without symptoms (5) Gr 3 hypocalcemia, hypokalemia, hypomagnesemia, hyponatremia or hyphosphatemia responding to medical care (6) Gr 3 hypercholeresterolemia or hypertriglyceridemia. A drug-related AE causing dose modification of study drug is also considered a DLT. Per protocol DLTs were analyzed in the first 28-day treatment cycle. The number of participants experiencing DLTs is reported here for all participants who got ≥1 dose of study drug.
Time frame: Cycle 1 (Up to 28 days)
Population: All participants who received ≥1 dose of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Level 1: Vorinostat 300 mg + Lenalidomide 10 mg | Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Level 2: Vorinostat 400 mg + Lenalidomide 10 mg | Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Level 3: Vorinostat 400 mg + Lenalidomide 15 mg | Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Level 4: Vorinostat 400 mg + Lenalidomide 20 mg | Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Level 5: Vorinostat 400 mg + Lenalidomide 25 mg | Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | 1 Participants |
Secondary
Number of Participants Experiencing Drug-Related Adverse Events (AEs)
An AE was defined as any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the Sponsor's product is also an AE. An AE was considered related to a drug as determined by the investigator based on exposure (evidence of exposure to drug), time course (time of AE onset versus drug-induced effect), likely cause (AE etiology related or un-related to drug), de-challenge (drug dose reduction/discontinuation) or re-challenge (drug re-exposure). Per protocol participants experiencing drug-related AEs were analyzed at the time of the protocol-specified final statistical analysis with a 3-September (Sep)-2012 data cut-off. The number of participants experiencing drug-related AEs is reported here for all participants who got ≥1 dose of study drug.
Time frame: Up to ~55 months (through pre-specified final statistical analysis cut-off date of 3-Sep-2012)
Population: All participants who received ≥1 dose of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Level 1: Vorinostat 300 mg + Lenalidomide 10 mg | Number of Participants Experiencing Drug-Related Adverse Events (AEs) | 2 Participants |
| Level 2: Vorinostat 400 mg + Lenalidomide 10 mg | Number of Participants Experiencing Drug-Related Adverse Events (AEs) | 3 Participants |
| Level 3: Vorinostat 400 mg + Lenalidomide 15 mg | Number of Participants Experiencing Drug-Related Adverse Events (AEs) | 3 Participants |
| Level 4: Vorinostat 400 mg + Lenalidomide 20 mg | Number of Participants Experiencing Drug-Related Adverse Events (AEs) | 3 Participants |
| Level 5: Vorinostat 400 mg + Lenalidomide 25 mg | Number of Participants Experiencing Drug-Related Adverse Events (AEs) | 17 Participants |
Other Pre-specified
Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD)
Best overall tumor response consisted of CR (negative M-protein immunofixation \[IF\], \<5% bone marrow \[BM\] plasma cells, no soft tissue plasmacytomas \[STP\]), NCR (positive M-protein IF, \<5% BM plasma cells, no STP), VGPR (≥90% M-protein decrease, \<5% BM plasma cells, no STP), PR (≥50% M-protein, BM plasma cells, STP decrease), MR (25-49% M-protein, BM plasma cells, STP decrease), SD (\<25% decrease-25% increase in M-protein, BM plasma cells; \<25% decrease-increase in definite STP) or PD (≥25% M-protein, BM plasma cells increase; new STP, lesions). Per protocol participants experiencing best overall response by CR, NCR, VGPR, PR, MR, SD or PD were analyzed as a single prespecified analysis at the time of protocol-specified final statistical analysis with a 3-Sep-2012 data cut-off. The number of participants experiencing best overall response by CR, NCR, VGPR, PR, MR, SD or PD is reported here for all participants who got ≥1 dose of study drug and had a post baseline efficacy assessment.
Time frame: Up to ~55 months (through pre-specified final statistical analysis cut-off date of 3-Sep-2012)
Population: All participants who received ≥1 dose of study treatment and had a post baseline efficacy assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Level 1: Vorinostat 300 mg + Lenalidomide 10 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | CR | 0 Participants |
| Level 1: Vorinostat 300 mg + Lenalidomide 10 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | PD | 1 Participants |
| Level 1: Vorinostat 300 mg + Lenalidomide 10 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | SD | 1 Participants |
| Level 1: Vorinostat 300 mg + Lenalidomide 10 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | VGPR | 1 Participants |
| Level 1: Vorinostat 300 mg + Lenalidomide 10 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | NCR | 0 Participants |
| Level 1: Vorinostat 300 mg + Lenalidomide 10 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | PR | 1 Participants |
| Level 1: Vorinostat 300 mg + Lenalidomide 10 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | MR | 0 Participants |
| Level 2: Vorinostat 400 mg + Lenalidomide 10 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | MR | 0 Participants |
| Level 2: Vorinostat 400 mg + Lenalidomide 10 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | PR | 1 Participants |
| Level 2: Vorinostat 400 mg + Lenalidomide 10 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | NCR | 1 Participants |
| Level 2: Vorinostat 400 mg + Lenalidomide 10 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | CR | 0 Participants |
| Level 2: Vorinostat 400 mg + Lenalidomide 10 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | SD | 1 Participants |
| Level 2: Vorinostat 400 mg + Lenalidomide 10 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | VGPR | 0 Participants |
| Level 2: Vorinostat 400 mg + Lenalidomide 10 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | PD | 1 Participants |
| Level 3: Vorinostat 400 mg + Lenalidomide 15 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | PR | 0 Participants |
| Level 3: Vorinostat 400 mg + Lenalidomide 15 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | CR | 0 Participants |
| Level 3: Vorinostat 400 mg + Lenalidomide 15 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | NCR | 0 Participants |
| Level 3: Vorinostat 400 mg + Lenalidomide 15 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | VGPR | 0 Participants |
| Level 3: Vorinostat 400 mg + Lenalidomide 15 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | MR | 1 Participants |
| Level 3: Vorinostat 400 mg + Lenalidomide 15 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | SD | 1 Participants |
| Level 3: Vorinostat 400 mg + Lenalidomide 15 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | PD | 1 Participants |
| Level 4: Vorinostat 400 mg + Lenalidomide 20 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | VGPR | 1 Participants |
| Level 4: Vorinostat 400 mg + Lenalidomide 20 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | MR | 0 Participants |
| Level 4: Vorinostat 400 mg + Lenalidomide 20 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | NCR | 0 Participants |
| Level 4: Vorinostat 400 mg + Lenalidomide 20 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | PD | 1 Participants |
| Level 4: Vorinostat 400 mg + Lenalidomide 20 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | SD | 0 Participants |
| Level 4: Vorinostat 400 mg + Lenalidomide 20 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | CR | 0 Participants |
| Level 4: Vorinostat 400 mg + Lenalidomide 20 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | PR | 1 Participants |
| Level 5: Vorinostat 400 mg + Lenalidomide 25 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | VGPR | 2 Participants |
| Level 5: Vorinostat 400 mg + Lenalidomide 25 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | PD | 1 Participants |
| Level 5: Vorinostat 400 mg + Lenalidomide 25 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | SD | 5 Participants |
| Level 5: Vorinostat 400 mg + Lenalidomide 25 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | MR | 2 Participants |
| Level 5: Vorinostat 400 mg + Lenalidomide 25 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | NCR | 0 Participants |
| Level 5: Vorinostat 400 mg + Lenalidomide 25 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | CR | 1 Participants |
| Level 5: Vorinostat 400 mg + Lenalidomide 25 mg | Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) | PR | 5 Participants |