Vorinostat (MK-0683, SAHA [Suberoylanilide Hydroxamic Acid]) + Lenalidomide + Dexamethasone in Multiple Myeloma (MM) (MK-0683-074)
Condition: Relapsed or Refractory Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Vorinostat; Lenalidomide; Dexamethasone
Intervention description: Vorinostat 300 mg or 400 mg QD via oral capsule on Days 1-7 and Days 15-21 of each 28-day cycle.; Lenalidomide 10 mg, 15 mg, 20 mg or 25 mg QD via oral capsule on Days 1-21 of each 28-day cycle.; Dexamethasone 40 mg QD via oral tablet on Days 1, 8, 15 and 22 of each 28-day cycle.
Intervention MeSH terms: Dexamethasone; Lenalidomide; Vorinostat
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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).
    

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