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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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
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, see Learn About Clinical Studies.

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:
Prednisone
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
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
Angiogenesis Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014