Vorinostat (MK-0683, SAHA [Suberoylanilide Hydroxamic Acid]) + Lenalidomide + Dexamethasone in Multiple Myeloma (MM) (MK-0683-074)
Relapsed or Refractory Multiple Myeloma
About this trial
This is an interventional treatment trial for Relapsed or Refractory Multiple Myeloma
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
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
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.
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.
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.
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.
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.