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NCT00642954 · REGISTRY CONDITION SEARCH

Vorinostat (MK-0683, SAHA [Suberoylanilide Hydroxamic Acid]) + Lenalidomide + Dexamethasone in Multiple Myeloma (MM) (MK-0683-074)

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1
Status at capture
COMPLETED
Registry last update
2020-11-18

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).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)

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outcome · POSTED

Number of Participants Experiencing Drug-Related Adverse Events (AEs)

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outcome · POSTED

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)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Participants will receive 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. Qualified participants who don't have disease progression can continue treatment after 8 cycles at the same dose and schedule, until progressive disease or unacceptable toxicity.
    intervention Names
    1. Drug: Vorinostat
    2. Drug: Lenalidomide
    3. Drug: Dexamethasone
    label
    Level 1: Vorinostat 300 mg + lenalidomide 10 mg
    type
    EXPERIMENTAL
  2. description
    Participants will receive 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. Qualified participants who don't have disease progression can continue treatment after 8 cycles at the same dose and schedule, until progressive disease or unacceptable toxicity.
    intervention Names
    1. Drug: Vorinostat
    2. Drug: Lenalidomide
    3. Drug: Dexamethasone
    label
    Level 2: Vorinostat 400 mg + lenalidomide 10 mg
    type
    EXPERIMENTAL
  3. description
    Participants will receive 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. Qualified participants who don't have disease progression can continue treatment after 8 cycles at the same dose and schedule, until progressive disease or unacceptable toxicity.
    intervention Names
    1. Drug: Vorinostat
    2. Drug: Lenalidomide
    3. Drug: Dexamethasone
    label
    Level 3: Vorinostat 400 mg + lenalidomide 15 mg
    type
    EXPERIMENTAL
  4. description
    Participants will receive 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. Qualified participants who don't have disease progression can continue treatment after 8 cycles at the same dose and schedule, until progressive disease or unacceptable toxicity.
    intervention Names
    1. Drug: Vorinostat
    2. Drug: Lenalidomide
    3. Drug: Dexamethasone
    label
    Level 4: Vorinostat 400 mg + lenalidomide 20 mg
    type
    EXPERIMENTAL
  5. description
    Participants will receive 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 for up to 8 cycles. Qualified participants who don't have disease progression can continue treatment after 8 cycles at the same dose and schedule, until progressive disease or unacceptable toxicity.
    intervention Names
    1. Drug: Vorinostat
    2. Drug: Lenalidomide
    3. Drug: Dexamethasone
    label
    Level 5: Vorinostat 400 mg + lenalidomide 25 mg
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Level 1: Vorinostat 300 mg + lenalidomide 10 mg
    2. Level 2: Vorinostat 400 mg + lenalidomide 10 mg
    3. Level 3: Vorinostat 400 mg + lenalidomide 15 mg
    4. Level 4: Vorinostat 400 mg + lenalidomide 20 mg
    5. Level 5: Vorinostat 400 mg + lenalidomide 25 mg
    description
    Vorinostat 300 mg or 400 mg QD via oral capsule on Days 1-7 and Days 15-21 of each 28-day cycle.
    name
    Vorinostat
    other Names
    1. MK-0683
    2. Suberoylanilide hydroxamic acid
    3. Zolinza
    type
    DRUG
  2. arm Group Labels
    1. Level 1: Vorinostat 300 mg + lenalidomide 10 mg
    2. Level 2: Vorinostat 400 mg + lenalidomide 10 mg
    3. Level 3: Vorinostat 400 mg + lenalidomide 15 mg
    4. Level 4: Vorinostat 400 mg + lenalidomide 20 mg
    5. Level 5: Vorinostat 400 mg + lenalidomide 25 mg
    description
    Lenalidomide 10 mg, 15 mg, 20 mg or 25 mg QD via oral capsule on Days 1-21 of each 28-day cycle.
    name
    Lenalidomide
    other Names
    1. Revlimid
    type
    DRUG
  3. arm Group Labels
    1. Level 1: Vorinostat 300 mg + lenalidomide 10 mg
    2. Level 2: Vorinostat 400 mg + lenalidomide 10 mg
    3. Level 3: Vorinostat 400 mg + lenalidomide 15 mg
    4. Level 4: Vorinostat 400 mg + lenalidomide 20 mg
    5. Level 5: Vorinostat 400 mg + lenalidomide 25 mg
    description
    Dexamethasone 40 mg QD via oral tablet on Days 1, 8, 15 and 22 of each 28-day cycle.
    name
    Dexamethasone
    other Names
    1. Decadron
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
31
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. description
    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.
    measure
    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)
    time Frame
    Up to ~55 months (through pre-specified final statistical analysis cut-off date of 3-Sep-2012)
primary Outcomes
  1. description
    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.
    measure
    Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
    time Frame
    Cycle 1 (Up to 28 days)
secondary Outcomes
  1. description
    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.
    measure
    Number of Participants Experiencing Drug-Related Adverse Events (AEs)
    time Frame
    Up to ~55 months (through pre-specified final statistical analysis cut-off date of 3-Sep-2012)
Full study description
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).
Source references
references
  1. citation
    Siegel DS, Richardson P, Dimopoulos M, Moreau P, Mitsiades C, Weber D, Houp J, Gause C, Vuocolo S, Eid J, Graef T, Anderson KC. Vorinostat in combination with lenalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma. Blood Cancer J. 2014 Feb 21;4(2):e182. doi: 10.1038/bcj.2014.1.
    pmid
    24562384
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice