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

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ClinicalTrials.gov Identifier: NCT01352338
Recruitment Status : Completed
First Posted : May 11, 2011
Last Update Posted : February 26, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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


Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Lenalidomide, endoxan, prednisone Drug: lenalidomide, endoxan, prednisone Phase 1 Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
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
Primary Completion Date : November 2014
Study Completion Date : February 2016


Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. phase 2 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT) [ Time Frame: 28 days ]
    - to evaluate progression-free survival

  3. phase 2 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT) [ Time Frame: 28 days ]
    - to evaluate overall survival

  4. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


Locations
Netherlands
Antonius Ziekenhuis Nieuwegein
Nieuwegein, Utrecht, Netherlands, 3435 CM
VU Medical Center
Amsterdam, Netherlands
UMC Utrecht
Utrecht, Netherlands, 3584CX
Sponsors and Collaborators
UMC Utrecht
Celgene Corporation
Investigators
Principal Investigator: Dr. N.C.W.J. Donk, van de, MD PhD UMC Utrecht
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: I.S. Nijhof, Drs, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01352338     History of Changes
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

Keywords provided by I.S. Nijhof, UMC Utrecht:
REPEAT
multiple myeloma
revlimid
lenalidomide
cyclophosphamide
endoxan
prednisone
lenalidomide refractory

Additional relevant MeSH terms:
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
Prednisone
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