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

This study is currently recruiting participants.
Verified September 2012 by UMC Utrecht
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: September 28, 2012
Last verified: September 2012

April 13, 2011
September 28, 2012
August 2011
August 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 ] [ 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
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 ] [ 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
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
May 2015
August 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
Both
18 Years to 80 Years
No
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
Netherlands
 
NCT01352338
RV-MM-PI-0630
Yes
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
September 2012

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