Revlimid, Endoxan, Prednison Evaluation After Prior Revlimid Treatment (REPEAT)
This study is currently recruiting participants.
Verified September 2012 by UMC Utrecht
Sponsor:
UMC Utrecht
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
I.S. Nijhof, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01352338
First received: April 13, 2011
Last updated: September 28, 2012
Last verified: September 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: Lenalidomide, endoxan, prednisone Drug: lenalidomide, endoxan, prednisone |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by UMC Utrecht:
Primary Outcome Measures:
- Phase 1 Revlimid, Endoxan, Prednisone Evaluation After prior revlimid Treatment (REPEAT) [ Time Frame: 29 days after start of treatment cycle 1 ] [ Designated as safety issue: Yes ]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 Outcome Measures:
- phase 1 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT) [ Time Frame: 29 days after start of treatment cycle 1 ] [ Designated as safety issue: Yes ]number of participants with adverse events
- phase 2 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT) [ Time Frame: 28 days ] [ Designated as safety issue: No ]- to evaluate progression-free survival
- phase 2 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT) [ Time Frame: 28 days ] [ Designated as safety issue: No ]- to evaluate overall survival
- phase 2 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT) [ Time Frame: 28 days ] [ Designated as safety issue: No ]- to evaluate the immunomodulatory effects of lenalidomide by using flow cytometric and cytokine analysis
| Estimated Enrollment: | 90 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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 |
Drug: Lenalidomide, endoxan, prednisone
dose-finding
Other Name: revlimid combined with endoxan and prednisone
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.
Other Name: revlimid combined with cyclophosphamide and prednisone
|
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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01352338
Contacts
| Contact: Inger Nijhof, MD | 003188-7555555 | i.s.nijhof@umcutrecht.nl |
| Contact: Niels van de Donk, MD PhD | 003188-7555555 | N.W.C.J.vandeDonk@umcutrecht.nl |
Locations
| Netherlands | |
| Antonius Ziekenhuis Nieuwegein | Recruiting |
| Nieuwegein, Utrecht, Netherlands, 3435 CM | |
| Contact: Harry Koene, MD PhD | |
| Contact: Niels Donk, van de, MD PhD N.W.C.J.vandeDonk@umcutrecht.nl | |
| Principal Investigator: Harry Koene, MD PhD | |
| VU Medical Center | Recruiting |
| Amsterdam, Netherlands | |
| Contact: Sonja Zweegman, dr. S.Zweegman@vumc.nl | |
| Contact: Yvonne Hartog den denhartog@vumc.nl | |
| Principal Investigator: Sonja Zweegman, dr. | |
| UMC Utrecht | Recruiting |
| Utrecht, Netherlands, 3584CX | |
| Contact: Inger Nijhof, MD 003188-7555555 i.s.nijhof@umcutrecht.nl | |
| Sub-Investigator: Inger Nijhof, MD | |
| Principal Investigator: Niels Donk van de, dr | |
| Principal Investigator: Henk Lokhorst, prof dr | |
Sponsors and Collaborators
UMC Utrecht
Celgene Corporation
Investigators
| Principal Investigator: | Dr. N.C.W.J. Donk, van de, MD PhD | UMC Utrecht |
More Information
No publications provided
| Responsible Party: | I.S. Nijhof, Drs, UMC Utrecht |
| ClinicalTrials.gov Identifier: | NCT01352338 History of Changes |
| Other Study ID Numbers: | RV-MM-PI-0630 |
| Study First Received: | April 13, 2011 |
| Last Updated: | September 28, 2012 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by UMC Utrecht:
|
REPEAT multiple myeloma revlimid lenalidomide |
cyclophosphamide endoxan prednisone lenalidomide refractory |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Cyclophosphamide |
Thalidomide Lenalidomide Prednisone Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Glucocorticoids |
ClinicalTrials.gov processed this record on May 19, 2013