Romidepsin in Combination With Lenalidomide in Adults With Relapsed or Refractory Lymphomas and Myeloma

NCT01755975 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2024-11-07

Study results available
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Summary

The treatments used to treat lymphoma and multiple myeloma sometimes do not always work well or they may only work for a short period of time. This is why new treatments are being tested.

This study will test a new combination of two drugs that are already approved by the Food and Drug Administration for treatment of certain kinds of blood cancers. These drugs are romidepsin and lenalidomide. Both these drugs by themselves have been used to treat lymphoma or multiple myeloma. However, while these drugs are routinely used alone, this is the first time they will be tested together. The mechanism of action of both drugs is not well understood but both have been shown to to be effective by themselves in lymphoma and multiple myeloma.

Conditions

Interventions

DRUG

Romidepsin

Romidepsin will be administered intravenously on days 1, 8, and 15 of a 28-day cycle.

DRUG

Lenalidomide

Lenalidomide will be taken orally daily for 21 days of a 28-day cycle.

Sponsors & Collaborators

  • St. Francis Hospital & Medical Center, Hartford CT

    collaborator OTHER
  • Weill Medical College of Cornell University

    collaborator OTHER
  • University of Nebraska

    collaborator OTHER
  • Celgene Corporation

    collaborator INDUSTRY
  • Biologics, Inc.

    collaborator INDUSTRY
  • Memorial Sloan Kettering Cancer Center

    lead OTHER

Principal Investigators

  • Steven Horwitz, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2023-10-31
Completion
2023-10-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01755975 on ClinicalTrials.gov