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A Phase 1 and Phase 2 Study of Lenalidomide (Revlimid) in Combination With Cyclophosphamide (Endoxan) and Prednison (REP) in Relapsed/Refractory Multiple Myeloma


Phase 1/Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

A Phase 1 and Phase 2 Study of Lenalidomide (Revlimid) in Combination With Cyclophosphamide (Endoxan) and Prednison (REP) in Relapsed/Refractory Multiple Myeloma


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Phase 1 Revlimid, Endoxan, Prednisone Evaluation After prior revlimid Treatment (REPEAT)

Outcome 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

Outcome Time Frame:

29 days after start of treatment cycle 1

Safety Issue:

Yes

Principal Investigator

Dr. N.C.W.J. Donk, van de, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UMC Utrecht

Authority:

Netherlands: Medical Ethics Review Committee (METC)

Study ID:

RV-MM-PI-0630

NCT ID:

NCT01352338

Start Date:

August 2011

Completion Date:

May 2015

Related Keywords:

  • Multiple Myeloma
  • REPEAT
  • multiple myeloma
  • revlimid
  • lenalidomide
  • cyclophosphamide
  • endoxan
  • prednisone
  • lenalidomide refractory
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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