Clinical trial · Interventional

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

A Phase I Study of Vorinostat in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

NCT00642954CI-TRIAL-00048339completedPhase 1Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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).

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Relapsed or Refractory Multiple Myeloma	Multiple Myeloma	CURATED_EXACT	0.90

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
Dexamethasone	Drug	Dexamethasone	ALIAS
Lenalidomide	Drug	Lenalidomide	ALIAS
Vorinostat	Drug	Vorinostat	ALIAS

Design

Arms and outcomes

Arms (5)

type
EXPERIMENTAL
label
Level 1: Vorinostat 300 mg + lenalidomide 10 mg
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.
interventionNames
1. Drug: Vorinostat
2. Drug: Lenalidomide
3. Drug: Dexamethasone
type
EXPERIMENTAL
label
Level 2: Vorinostat 400 mg + lenalidomide 10 mg
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.
interventionNames

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (1)

RESULTSiegel 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