Revlimid, Endoxan, Prednison Evaluation After Prior Revlimid Treatment (REPEAT) (REPEAT)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01352338 |
Recruitment Status :
Completed
First Posted : May 11, 2011
Last Update Posted : February 26, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Myeloma | Drug: Lenalidomide, endoxan, prednisone Drug: lenalidomide, endoxan, prednisone | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 82 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | August 2011 |
Actual Primary Completion Date : | November 2014 |
Actual Study Completion Date : | February 2016 |
Arm | Intervention/treatment |
---|---|
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 |
- Phase 1 Revlimid, Endoxan, Prednisone Evaluation After prior revlimid Treatment (REPEAT) [ Time Frame: 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
- 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 ]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 ]- to evaluate progression-free survival
- phase 2 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT) [ Time Frame: 28 days ]- to evaluate overall survival
- phase 2 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT) [ Time Frame: 28 days ]- to evaluate the immunomodulatory effects of lenalidomide by using flow cytometric and cytokine analysis
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01352338
Netherlands | |
Antonius Ziekenhuis Nieuwegein | |
Nieuwegein, Utrecht, Netherlands, 3435 CM | |
VU Medical Center | |
Amsterdam, Netherlands | |
UMC Utrecht | |
Utrecht, Netherlands, 3584CX |
Principal Investigator: | Dr. N.C.W.J. Donk, van de, MD PhD | UMC Utrecht |
Responsible Party: | I.S. Nijhof, Drs, UMC Utrecht |
ClinicalTrials.gov Identifier: | NCT01352338 |
Other Study ID Numbers: |
RV-MM-PI-0630 |
First Posted: | May 11, 2011 Key Record Dates |
Last Update Posted: | February 26, 2016 |
Last Verified: | February 2016 |
REPEAT multiple myeloma revlimid lenalidomide |
cyclophosphamide endoxan prednisone lenalidomide refractory |
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 Prednisone |
Cyclophosphamide Lenalidomide Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |