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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

Page last updated: August 23, 2015

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