Loading clinical trials...

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

COMPLETEDPHASE1

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

NCT00642954•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

February 13, 2008

Primary Completion Date

September 3, 2012

Completion Date

August 20, 2013

Last Updated

November 18, 2020

Enrollment

ACTUAL participants

Conditions

Relapsed or Refractory Multiple Myeloma

Interventions

Vorinostat

DRUG

Lenalidomide

DRUG

Dexamethasone

DRUG

A Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma

NCT07138209

Relapsed or Refractory Multiple Myeloma

View study

RECRUITINGPHASE1

YTS104 Cell Injection for the Treatment of Relapsed or Refractory Multiple Myeloma

NCT05913804

Relapsed or Refractory Multiple Myeloma

View study

RECRUITINGNA

Intravenous Autologous CD19 CAR-T Cells for R/ R MM, B-ALL, and B-Cell Lymphoma

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma

YTS104 Cell Injection for the Treatment of Relapsed or Refractory Multiple Myeloma

Intravenous Autologous CD19 CAR-T Cells for R/ R MM, B-ALL, and B-Cell Lymphoma

Pre-Approval Access Program for Talquetamab in Relapsed or Refractory Multiple Myeloma

A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma

Teclistamab Expanded Access Treatment Protocol for Relapsed or Refractory Multiple Myeloma Patients