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

Phase 1

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: lenalidomide, endoxan, prednisone

• Registration Number: NCT01352338
• Lead Sponsor: UMC Utrecht

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.

Study Timeline

• Study First Submitted: 2011-04-13
• Study First Submitted QC: 2011-05-10
• Study First Posted: 2011-05-11
• Study Start: 2011-08
• Primary Completion: 2014-11
• Status Verified: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2016-02-25
• Last Update Posted: 2016-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
lenalidomide, endoxan, prednisone	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

Primary Outcome Measures

Name	Time	Method
Phase 1 Revlimid, Endoxan, Prednisone Evaluation After prior revlimid Treatment (REPEAT)	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 Outcome Measures

Name	Time	Method
phase 1 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT)	29 days after start of treatment cycle 1	number of participants with adverse events
phase 2 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT)	28 days	- to evaluate the immunomodulatory effects of lenalidomide by using flow cytometric and cytokine analysis

Trial Locations

Locations (3)

Antonius Ziekenhuis Nieuwegein; 🇳🇱 Nieuwegein, Utrecht, Netherlands

VU Medical Center; 🇳🇱 Amsterdam, Netherlands

UMC Utrecht; 🇳🇱 Utrecht, Netherlands