Romidepsin in Combination With Lenalidomide in Adults With Relapsed or Refractory Lymphomas and Myeloma
|ClinicalTrials.gov Identifier: NCT01755975|
Recruitment Status : Active, not recruiting
First Posted : December 24, 2012
Last Update Posted : March 6, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma Non-Hodgkin's Lymphoma||Drug: Romidepsin Drug: Lenalidomide||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib/IIa Study of Romidepsin in Combination With Lenalidomide in Adults With Relapsed or Refractory Lymphomas and Myeloma|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
U.S. FDA Resources
Experimental: Romidepsin and Lenalidomide
This will be a multicentered, open label, phase Ib/IIa trial of romidepsin and lenalidomide in patients with relapsed or refractory lymphomas or multiple myeloma. Lenalidomide will be provided in accordance with the Celgene Corporation's Revlimid REMS® program. Per standard Revlimid REMS® program requirements, all physicians who prescribe lenalidomide for research subjects enrolled into this trial, and all research subjects enrolled into this trial, must be registered in, and must comply with, all requirements of the Revlimid REMS® program. Only enough lenalidomide for one cycle of therapy will be supplied to the patient each cycle.
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.
- define the maximum tolerated dose [ Time Frame: 1 year ]The phase Ib portion of the study is designed to determine the MTD of romidepsin and lenalidomide.
- safety and toxicity [ Time Frame: 1 year ]Subjects will be evaluated for AEs at each visit with the NCI CTCAE v4.0 used as a guide for the grading of severity.
- assess the overall response rate (ORR) [ Time Frame: 1 year ]Overall response rate (ORR), complete response rate, very good partial response/partial response rate will be summarized using proportions and confidence intervals will be provided.
- assess clinical benefit rate (CBr) [ Time Frame: 1 year ]CBr is defined as CR, VGPR, PR or MR (minimal response) in myeloma patients.
- assess the time to response (TTR) [ Time Frame: 1 year ]duration of response (DOR), and event free survival (EFS). Time to response, duration of response and event free survival will be analyzed by routine survival analysis tools such as Kaplan-Meier estimation or competing risks method.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755975
|United States, Connecticut|
|Saint Francis/Mount Sinai Regional Cancer Center|
|Hartford, Connecticut, United States, 06105|
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198-7680|
|United States, New Jersey|
|Memorial Sloan Kettering at Basking Ridge|
|Basking Ridge, New Jersey, United States, 07920|
|United States, New York|
|Memorial Sloan Kettering Cancer Center at Commack|
|Commack, New York, United States, 11725|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Weill Cornell Medical Center|
|New York, New York, United States|
|Memorial Sloan Kettering Cancer Center at Mercy|
|Rockville Centre, New York, United States, 11570|
|Principal Investigator:||Steven Horwitz, MD||Memorial Sloan Kettering Cancer Center|