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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
Lenalidomide, endoxan, prednisone
lenalidomide, endoxan, prednisone
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring REPEAT, multiple myeloma, revlimid, lenalidomide, cyclophosphamide, endoxan, prednisone, lenalidomide refractory

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Antonius Ziekenhuis Nieuwegein
  • VU Medical Center
  • UMC Utrecht

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

lenalidomide, endoxan, prednisone

Arm Description

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

Outcomes

Primary Outcome Measures

Phase 1 Revlimid, Endoxan, Prednisone Evaluation After prior revlimid Treatment (REPEAT)
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)
number of participants with adverse events
phase 2 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT)
- to evaluate progression-free survival
phase 2 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT)
- to evaluate overall survival
phase 2 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT)
- to evaluate the immunomodulatory effects of lenalidomide by using flow cytometric and cytokine analysis

Full Information

First Posted
April 13, 2011
Last Updated
February 25, 2016
Sponsor
UMC Utrecht
Collaborators
Celgene Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01352338
Brief Title
Revlimid, Endoxan, Prednison Evaluation After Prior Revlimid Treatment (REPEAT)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht
Collaborators
Celgene Corporation

4. Oversight

Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
REPEAT, multiple myeloma, revlimid, lenalidomide, cyclophosphamide, endoxan, prednisone, lenalidomide refractory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lenalidomide, endoxan, prednisone
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Lenalidomide, endoxan, prednisone
Other Intervention Name(s)
revlimid combined with endoxan and prednisone
Intervention Description
dose-finding
Intervention Type
Drug
Intervention Name(s)
lenalidomide, endoxan, prednisone
Other Intervention Name(s)
revlimid combined with cyclophosphamide and prednisone
Intervention Description
oral therapy with lenalidomide 25mg a day during 3 of 4 week cycles. Number of Cycles: until progression or unacceptable toxicity develops.
Primary Outcome Measure Information:
Title
Phase 1 Revlimid, Endoxan, Prednisone Evaluation After prior revlimid Treatment (REPEAT)
Description
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
Time Frame
29 days after start of treatment cycle 1
Secondary Outcome Measure Information:
Title
phase 1 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT)
Description
number of participants with adverse events
Time Frame
29 days after start of treatment cycle 1
Title
phase 2 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT)
Description
- to evaluate progression-free survival
Time Frame
28 days
Title
phase 2 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT)
Description
- to evaluate overall survival
Time Frame
28 days
Title
phase 2 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT)
Description
- to evaluate the immunomodulatory effects of lenalidomide by using flow cytometric and cytokine analysis
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. N.C.W.J. Donk, van de, MD PhD
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antonius Ziekenhuis Nieuwegein
City
Nieuwegein
State/Province
Utrecht
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
VU Medical Center
City
Amsterdam
Country
Netherlands
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3584CX
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
27647864
Citation
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.
Results Reference
derived

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

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