Multiple Myeloma Clinical Trial
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
The purpose of this research study is to determine the highest dose of lenalidomide and RAD001 that can be given without causing too many serious side effects. Another goal of this research study is to look at how the participants cancer may respond to the study treatment. Additionally, we wish to learn more about how the body breaks down and gets rid of the study drugs. We will also try to find substances in the blood (biomarkers) that may help predict how myeloma will respond to study treatment.
- 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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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