RAD001 and Lenalidomide in the Treatment of Subjects With Relapsed and Relapsed/Refractory Multiple Myeloma
|ClinicalTrials.gov Identifier: NCT00729638|
Recruitment Status : Completed
First Posted : August 7, 2008
Last Update Posted : August 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: RAD001 Drug: lenalidomide||Phase 1|
- Researchers are looking for the highest doses of RAD001 and lenalidomide used in combination that can be given safely so small groups of people will be enrolled in steps in this trial. The first group will be given a certain dose of RAD001 and a certain dose of lenalidomide. If they have few or manageable side effects, the next small group of people will be enrolled with a higher dose of RAD001 and/or a higher dose of lenalidomide. This will continue until the highest dose of the drugs used is determined.
- Study treatment will be given in 28 day cycles. Both RAD001 and lenalidomide are pills that are taken orally. Both drugs will be started on the same day. RAD001 will be taken either every other day or every day for the first 3 weeks (days 1-21) of each 28-day cycle. Lenalidomide will be taken daily for the first 3 weeks (days 1-21) of each cycle.
- Participants will come to the clinic weekly during the first cycle to monitor side effects. The following will be performed at these clinic visits: physical examination, medical history update, questionnaires, and blood work.
- On cycles 2-8, participants will come to the clinic on Day 1 of each cycle. The following will be performed at this clinic visit: physical examination, medical history update, questionnaire, and blood word.
- At the end of cycle 8, a skeletal survey, bone marrow aspiration and biopsy will be performed to check response to study treatment.
- Participants may continue to receive RAD001 and lenalidomide beyond 8 cycles if their cancer does not get worse and they do not have unacceptable side effects.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Phase I Study of the Safety of and Efficacy of RAD001 in Combination With Lenalidomide in the Treatment of Subjects With Relapsed and Relapsed/Refractory Multiple Myeloma|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||November 2009|
U.S. FDA Resources
Experimental: Single arm
Single arm phase I study
Dose levels will change: Taken orally either every other day for the first three weeks of each cycle or taken every day for the first three weeks of each cycle.Drug: lenalidomide
Dose level will vary: taken orally 30-60 minutes after taking RAD001 every day for the first three weeks of each cycle.
- To evaluate the safety of RAD001 when given in combination with lenalidomide and to identify the maximum tolerated dose (MTD) as well as a recommended Phase 2 dose for the combination in this patient population. [ Time Frame: 2 years ]
- To evaluate the response to the combination of RAD001 and lenalidomide in subjects with multiple myeloma. [ Time Frame: 2 years ]
- To determine the pharmacokinetics of RAD001 and lenalidomide. [ Time Frame: 2 years ]
- To identify possible surrogate markers to better define mechanisms of action for the combination of the two drugs. [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00729638
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|United States, Wisconsin|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226`|
|Principal Investigator:||Noopur Raje, MD||Massachusetts General Hospital|