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

Sponsor

UMC Utrecht (Other)

Overall Status

Completed

CT.gov ID

NCT01352338

Collaborator

Celgene Corporation (Industry)

Enrollment

Locations

Arm

Duration (Months)

27.3

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: Lenalidomide, endoxan, prednisone Drug: lenalidomide, endoxan, prednisone	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

82 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Lenalidomide, endoxan, prednisone dose-finding Other Names: revlimid combined with endoxan and prednisone 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. Other Names: revlimid combined with cyclophosphamide and prednisone

Arm

Intervention/Treatment

Experimental: 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

Drug: Lenalidomide, endoxan, prednisone

dose-finding

Other Names:

revlimid combined with endoxan and prednisone

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.

Other Names:

revlimid combined with cyclophosphamide and prednisone

Outcome Measures

Primary Outcome Measures

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

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 progression-free survival
phase 2 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT) [28 days]
- to evaluate overall survival
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