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

Study 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.

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

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: Lenalidomide, endoxan, prednisone
* Drug: lenalidomide, endoxan, prednisone


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lenalidomide, endoxan, prednisone<br>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<br>* dose-finding<br>* Other names: revlimid combined with endoxan and prednisone;Drug: lenalidomide, endoxan, prednisone<br>* oral therapy with lenalidomide 25mg a day during 3 of 4 week cycles. Number of Cycles: until progression or unacceptable toxicity develops.<br>* Other names: revlimid combined with cyclophosphamide and prednisone;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
REPEAT, multiple myeloma, revlimid, lenalidomide, cyclophosphamide, endoxan, prednisone, lenalidomide refractory