A Phase 1 and Phase 2 Study of Lenalidomide (Revlimid) in Combination With Cyclophosphamide (Endoxan) and Prednison (REP) in Relapsed/Refractory Multiple Myeloma
Overview
- Phase
- Phase 1
- Intervention
- lenalidomide, endoxan, prednisone
- Conditions
- Multiple Myeloma
- Sponsor
- UMC Utrecht
- Enrollment
- 82
- Locations
- 3
- Primary Endpoint
- Phase 1 Revlimid, Endoxan, Prednisone Evaluation After prior revlimid Treatment (REPEAT)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
Study Phase: phase 1 and phase 2
Objective: Evaluation of the effect of lenalidomide, cyclophophamide and prednisone (REP) in patients with relapsed multiple myeloma previously treated with lenalidomide
Study design: prospective, multicenter, non-randomized
Detailed Description
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.
Investigators
I.S. Nijhof
Drs
UMC Utrecht
Eligibility Criteria
Inclusion Criteria
- •salmon \& Durie stage II/III A or B
- •previous lenalidomide refractory disease
- •patient commits to pregnancy prevention programme
Exclusion Criteria
- •non-secretory myeloma
- •known hypersensitivity to lenalidomide
- •inadequate marrow reserve
Arms & Interventions
lenalidomide, endoxan, prednisone
lenalidomide 25mg, oral therapy, once a day, 4 weeks cycles. Lenalidomide is used 3 of the 4 weeks. Lenalidomide is combined with endoxan and prednisone
Intervention: lenalidomide, endoxan, prednisone
Outcomes
Primary Outcomes
Phase 1 Revlimid, Endoxan, Prednisone Evaluation After prior revlimid Treatment (REPEAT)
Time Frame: 29 days after start of treatment cycle 1
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
Secondary Outcomes
- phase 1 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT)(29 days after start of treatment cycle 1)
- phase 2 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT)(28 days)