Revlimid, Endoxan, Prednison Evaluation After Prior Revlimid Treatment (REPEAT)
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
REPEAT, multiple myeloma, revlimid, lenalidomide, cyclophosphamide, endoxan, prednisone, lenalidomide refractory
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Lenalidomide, endoxan, prednisone Type: Drug
Name: lenalidomide, endoxan, prednisone Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
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
Locations
Antonius Ziekenhuis Nieuwegein
Nieuwegein, Utrecht, Netherlands
Status: Recruiting
Contact: Harry Koene, MD PhD
VU Medical Center
Amsterdam, Netherlands
Status: Recruiting
Contact: Sonja Zweegman, dr. - S.Zweegman@vumc.nl
UMC Utrecht
Utrecht, Netherlands
Status: Recruiting
Contact: Inger Nijhof, MD - 003188-7555555 - i.s.nijhof@umcutrecht.nl
Start Date
August 2011
Completion Date
December 2015
Sponsors
UMC Utrecht
Source
UMC Utrecht
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page