NCT01352338

Revlimid, Endoxan, Prednison Evaluation After Prior Revlimid Treatment (REPEAT)

A Phase 1 and Phase 2 Study of Lenalidomide (Revlimid) in Combination With Cyclophosphamide (Endoxan) and Prednison (REP) in Relapsed/Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Lenalidomide, endoxan, prednisone	dose-finding
DRUG	lenalidomide, endoxan, prednisone	oral therapy with lenalidomide 25mg a day during 3 of 4 week cycles. Number of Cycles: until progression or unacceptable toxicity develops.

Timeline

• Start date: 2011-08-01
• Primary completion: 2014-11-01
• Completion: 2016-02-01
• First posted: 2011-05-11
• Last updated: 2016-02-26

Locations

3 sites across 1 country: Netherlands