Treatment With Lenalidomide, Bendamustine and Prednisone (RBP) in Patients With Relapsed or Refractory Multiple Myeloma

NCT01002703 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-08-12

No results posted yet for this study

Summary

Define maximum tolerable dose of the combination lenalidomide, bendamustine, prednisone.

Conditions

Interventions

DRUG

Lenalidomide, Bendamustine, Prednisone

During the study the first cohort of subjects receive a starting dose of lenalidomide 10mg/d d1-21, bendamustine 60mg/m²/d d1-2 and prednisone 100mg/d d1-4. Escalation steps will include 15, 20 and 25 mg of lenalidomide and 75mg/m² for bendamustine.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY
  • Mundipharma Pte Ltd.

    collaborator INDUSTRY
  • Amgen

    collaborator INDUSTRY
  • University of Leipzig

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-10-31
Completion
2014-10-31

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01002703 on ClinicalTrials.gov