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

Conditions

Multiple Myeloma

Keywords

REPEAT, multiple myeloma, revlimid, lenalidomide, cyclophosphamide, endoxan, prednisone, lenalidomide refractory

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.

Pramod K. Mistry, Pablo Bianculli, Isabela Batsu, Walter Heine, Antonio Oliveira-dos-Santos et al. (7 authors)

Molecular Genetics and Metabolism2023-02-01

10.1016/j.ymgme.2022.107225

Phase 1/2 study of lenalidomide combined with low-dose cyclophosphamide and prednisone in lenalidomide-refractory multiple myeloma

Inger S. Nijhof, Laurens E. Franssen, Mark‐David Levin, Gerard M.J. Bos, Annemiek Broijl et al. (23 authors)

Blood2016-09-2056 citations

10.1182/blood-2016-07-729236

Phase 1/2 Trial Of Lenalidomide In Combination With Cyclophosphamide and Prednisone (REP) In Patients With Lenalidomide-Refractory Multiple Myeloma (REPEAT-study)

Inger S. Nijhof, Sonja Zweegman, Mark‐David Levin, Harry R. Koene, Aart Beeker et al. (18 authors)

Blood2013-11-152 citations

10.1182/blood.v122.21.287.287

Interventions

DRUGLenalidomide, endoxan, prednisone

dose-finding

DRUGlenalidomide, endoxan, prednisone

oral therapy with lenalidomide 25mg a day during 3 of 4 week cycles. Number of Cycles: until progression or unacceptable toxicity develops.

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Netherlands

Outcome results

None listed