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
- 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
- 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
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Noopur Raje, MD
Massachusetts General Hospital
United States: Food and Drug Administration
|Mayo Clinic||Rochester, Minnesota 55905|
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Medical College of Wisconsin||Milwaukee, Wisconsin 53226|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|