Status:
COMPLETED
Vorinostat (MK-0683, SAHA [Suberoylanilide Hydroxamic Acid]) + Lenalidomide + Dexamethasone in Multiple Myeloma (MM) (MK-0683-074)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Relapsed or Refractory Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 do...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 13 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2013
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00642954
Start Date
February 13 2008
End Date
August 20 2013
Last Update
November 18 2020
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