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

UMC Utrecht

Status and phase: Completed; Phase 2; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: Lenalidomide, endoxan, prednisone; Drug: lenalidomide, endoxan, prednisone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01352338

RV-MM-PI-0630

Details and patient eligibility

About

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

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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82 participants in 1 patient group

lenalidomide, endoxan, prednisone

Experimental group

Description:

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

Treatment:

Drug: Lenalidomide, endoxan, prednisone