A Phase 1 and Phase 2 Study of Lenalidomide (Revlimid) in Combination With Cyclophosphamide (Endoxan) and Prednison (REP) in Relapsed/Refractory Multiple Myeloma
The REPEAT-study is a prospective, multicenter, non-randomized phase 1 and phase 2 study in
which we evaluate the effect of lenalidomide, cyclophosphamide and prednisone (REP-therapy)
in patients with relapsed multiple myeloma, previously treated with lenalidomide and
refractory to lenalidomide monotherapy.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase 1 Revlimid, Endoxan, Prednisone Evaluation After prior revlimid Treatment (REPEAT)
To determine the maximum tolerated dose (MTD) and recommended phase 2 dose level (RDL) of lenalidomide administered during 21 days of a 4 weeks cycle, combined with continuous cyclophosphamide and prednisone
29 days after start of treatment cycle 1
Yes
Dr. N.C.W.J. Donk, van de, MD PhD
Principal Investigator
UMC Utrecht
Netherlands: Medical Ethics Review Committee (METC)
RV-MM-PI-0630
NCT01352338
August 2011
May 2015
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