Clinical trial NCT01352338: Revlimid, Endoxan, Prednison Evaluation After Prior Revlimid Treatment (REPEAT)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Multiple Myeloma
Keywords: REPEAT
multiple myeloma
revlimid
lenalidomide
cyclophosphamide
endoxan
prednisone
lenalidomide refractory
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2011-05-11
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Phase 1 Revlimid, Endoxan, Prednisone Evaluation After prior revlimid Treatment (REPEAT)
timeFrame: 29 days after start of treatment cycle 1
Secondary outcomes:
measure: phase 1 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT)
timeFrame: 29 days after start of treatment cycle 1
measure: phase 2 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT)
timeFrame: 28 days
measure: phase 2 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT)
timeFrame: 28 days
measure: phase 2 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT)
timeFrame: 28 days
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: Antonius Ziekenhuis Nieuwegein
state: Utrecht
city: Amsterdam
country: Netherlands
facility: VU Medical Center
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: UMC Utrecht
name: Dr. N.C.W.J. Donk, van de, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nijhof IS, Franssen LE, Levin MD, Bos GMJ, Broijl A, Klein SK, Koene HR, Bloem AC, Beeker A, Faber LM, van der Spek E, Ypma PF, Raymakers R, van Spronsen DJ, Westerweel PE, Oostvogels R, van Velzen J, van Kessel B, Mutis T, Sonneveld P, Zweegman S, Lokhorst HM, van de Donk NWCJ. Phase 1/2 study of lenalidomide combined with low-dose cyclophosphamide and prednisone in lenalidomide-refractory multiple myeloma. Blood. 2016 Nov 10;128(19):2297-2306. doi: 10.1182/blood-2016-07-729236. Epub 2016 Sep 19.