Revlimid, Endoxan, Prednison Evaluation After Prior Revlimid Treatment (REPEAT)
Information source: UMC Utrecht
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Myeloma
Intervention: Lenalidomide, endoxan, prednisone (Drug); lenalidomide, endoxan, prednisone (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: UMC Utrecht Official(s) and/or principal investigator(s): Dr. N.C.W.J. Donk, van de, MD PhD, Principal Investigator, Affiliation: UMC Utrecht
Overall contact: Inger Nijhof, MD, Phone: 003188-7555555, Email: i.s.nijhof@umcutrecht.nl
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
Clinical Details
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 design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Phase 1 Revlimid, Endoxan, Prednisone Evaluation After prior revlimid Treatment (REPEAT)
Secondary outcome: phase 1 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT)phase 2 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT) phase 2 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT) phase 2 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT)
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
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Inger Nijhof, MD, Phone: 003188-7555555, Email: i.s.nijhof@umcutrecht.nl
VU Medical Center, Amsterdam, Netherlands; Recruiting Sonja Zweegman, dr., Email: S.Zweegman@vumc.nl Yvonne Hartog den, Email: denhartog@vumc.nl Sonja Zweegman, dr., Principal Investigator
UMC Utrecht, Utrecht 3584CX, Netherlands; Recruiting Inger Nijhof, MD, Phone: 003188-7555555, Email: i.s.nijhof@umcutrecht.nl Inger Nijhof, MD, Sub-Investigator Niels Donk van de, dr, Principal Investigator Henk Lokhorst, prof dr, Principal Investigator
Antonius Ziekenhuis Nieuwegein, Nieuwegein, Utrecht 3435 CM, Netherlands; Recruiting Harry Koene, MD PhD Niels Donk, van de, MD PhD, Email: N.W.C.J.vandeDonk@umcutrecht.nl Harry Koene, MD PhD, Principal Investigator
Additional Information
Starting date: August 2011
Last updated: March 17, 2015
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