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

NCT ID: NCT01352338

Last Updated: 2016-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2016-02-29

Brief Summary

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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

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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.

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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lenalidomide, endoxan, prednisone

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

Group Type EXPERIMENTAL

Lenalidomide, endoxan, prednisone

Intervention Type DRUG

dose-finding

lenalidomide, endoxan, prednisone

Intervention Type DRUG

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

Interventions

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Lenalidomide, endoxan, prednisone

dose-finding

Intervention Type DRUG

lenalidomide, endoxan, prednisone

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

Intervention Type DRUG

Other Intervention Names

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revlimid combined with endoxan and prednisone revlimid combined with cyclophosphamide and prednisone

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene Corporation

INDUSTRY

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role lead

Responsible Party

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I.S. Nijhof

Drs

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr. N.C.W.J. Donk, van de, MD PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

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Antonius Ziekenhuis Nieuwegein

Nieuwegein, Utrecht, Netherlands

Site Status

UMC Utrecht

Utrecht, Utrecht, Netherlands

Site Status

VU Medical Center

Amsterdam, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 27647864 (View on PubMed)

Other Identifiers

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RV-MM-PI-0630

Identifier Type: -

Identifier Source: org_study_id

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