Clinical trial NCT00642954: Vorinostat (MK-0683, SAHA [Suberoylanilide Hydroxamic Acid]) + Lenalidomide + Dexamethasone in Multiple Myeloma (MM) (MK-0683-074)
Official title: A Phase I Study of Vorinostat in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Relapsed or Refractory Multiple Myeloma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-03-25
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
timeFrame: Cycle 1 (Up to 28 days)
Secondary outcomes:
measure: Number of Participants Experiencing Drug-Related Adverse Events (AEs)
timeFrame: Up to ~55 months (through pre-specified final statistical analysis cut-off date of 3-Sep-2012)
Other outcomes:
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)
timeFrame: Up to ~55 months (through pre-specified final statistical analysis cut-off date of 3-Sep-2012)
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
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.