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

Multiple Myeloma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01352338
• Other study ID #: RV-MM-PI-0630
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 13, 2011
• Last updated: February 25, 2016
• Start date: August 2011
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: February 2016
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Lenalidomide, endoxan, prednisone
dose-finding
• 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.

Locations

Country	Name	City	State
Netherlands	VU Medical Center	Amsterdam
Netherlands	Antonius Ziekenhuis Nieuwegein	Nieuwegein	Utrecht
Netherlands	UMC Utrecht	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
UMC Utrecht	Celgene Corporation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	29 days after start of treatment cycle 1	Yes
Secondary	phase 1 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT)	number of participants with adverse events	29 days after start of treatment cycle 1	Yes
Secondary	phase 2 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT)	- to evaluate progression-free survival	28 days	No
Secondary	phase 2 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT)	- to evaluate overall survival	28 days	No
Secondary	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	28 days	No