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

• ClinicalTrials.gov Identifier: NCT01352338
• Recruitment Status: Completed
• First Posted: May 11, 2011
• Last Update Posted: February 26, 2016
• Sponsor: UMC Utrecht
• Collaborator: Celgene Corporation
• Information provided by (Responsible Party): I.S. Nijhof, UMC Utrecht

Tracking Information

• First Submitted Date: April 13, 2011
• First Posted Date: May 11, 2011
• Last Update Posted Date: February 26, 2016
• Study Start Date: August 2011
• Actual Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 10, 2011)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 10, 2011)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Multiple Myeloma

Intervention

• 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

Study Arms

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

Interventions:

• Drug: Lenalidomide, endoxan, prednisone
• Drug: lenalidomide, endoxan, prednisone

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 25, 2016): 82
• Original Estimated Enrollment (submitted: May 10, 2011): 90
• Actual Study Completion Date: February 2016
• Actual Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT01352338
• Other Study ID Numbers: RV-MM-PI-0630
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: I.S. Nijhof, UMC Utrecht
• Original Responsible Party: Dr. N.W.C.J. van de Donk, UMC Utrecht
• Current Study Sponsor: UMC Utrecht
• Original Study Sponsor: Same as current
• Collaborators: Celgene Corporation

Investigators

• Principal Investigator: Dr. N.C.W.J. Donk, van de, MD PhD; UMC Utrecht

• PRS Account: UMC Utrecht
• Verification Date: February 2016