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

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
I.S. Nijhof, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01352338
First received: April 13, 2011
Last updated: February 25, 2016
Last verified: February 2016
April 13, 2011
February 25, 2016
August 2011
November 2014   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01352338 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Revlimid, Endoxan, Prednison Evaluation After Prior Revlimid Treatment (REPEAT)
A Phase 1 and Phase 2 Study of Lenalidomide (Revlimid) in Combination With Cyclophosphamide (Endoxan) and Prednison (REP) in Relapsed/Refractory Multiple Myeloma

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

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.
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Multiple Myeloma
  • 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
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
Nijhof IS, Franssen LE, Levin MD, Bos GM, 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 NW. Phase 1/2 study of lenalidomide combined with low-dose cyclophosphamide and prednisone in lenalidomide-refractory multiple myeloma. Blood. 2016 Sep 19. pii: blood-2016-07-729236. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
February 2016
November 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01352338
RV-MM-PI-0630
Yes
Not Provided
Not Provided
I.S. Nijhof, UMC Utrecht
UMC Utrecht
Celgene Corporation
Principal Investigator: Dr. N.C.W.J. Donk, van de, MD PhD UMC Utrecht
UMC Utrecht
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP