MedTrace Logo

Bendamustine, Lenalidomide (Revlimid®) and Dexamethasone (BRd) as 2nd-line Therapy for Patients With Relapsed or Refractory Multiple Myeloma

NCT01701076 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-08-24

No results posted yet for this study

Summary

Almost all patients with multiple myeloma who survive initial treatment will eventually relapse and require further therapy.

Background: Treatment with lenalidomide and dexamethasone has proven efficacy in two large randomized trials (MM-009 and MM-010) leading to a time to progression (TTP) of 17.1 months for patients with only one prior therapy and a TTP of 10.6 months for 2 and more prior therapies, respectively \[1-3\]. Continuous treatment with lenalidomide and dexamethasone until disease progression is therefore considered a standard therapy for second line treatment in multiple myeloma patients. However, only a relatively low rate of high quality response (CR, complete response and VGPR, very good partial response) is achieved. High quality responses are associated with with improved progression-free survival and overall survival \[4\].

Trial: The aim of this trial is to improve high quality response rates for patients with relapsed or refractory multiple myeloma in the 2nd line treatment. This aim shall be achieved by the addition a third anti-myeloma drug (bendamustine) to the established backbone of lenalidomide/ dexamethasone.

Treatment regimen:

* Induction Treatment Phase: Cycles 1-6 Bendamustine 75mg/m2/d day 1 and 2, lenalidomide 25mg/d 1-21, dexamethasone 40mg / 20mg (for patients \> 75years) d 1, 8, 15, 22.
* Maintenance Treatment Phase: Cycles 7-18 lenalidomide 25mg/d 1-21, dexamethasone 40mg / 20mg (for patients \> 75 years) d 1, 8, 15, 22.

Due to hematoxicity of bendamustine and lenalidomide, administration of pegfilgrastim is mandatory in the induction treatment phase (BRd-regimen)for all patients experiencing severe neutropenia.

The aim of this study is to achieve high quality response rates (CR, VGPR) of ≥ 40%. If this aim is achieved, the treatment of bendamustine in combination with the established lenalidomide/ dexamethasone regimen will be considered promising.

Besides efficacy, the safety of this three-drug regimen is evaluated in this trial.

Conditions

Interventions

DRUG

Bendamustine

Induction treatment phase (cycle 1-6): * Bendamustine 75 mg/m2 i.v day 1 and 2 * Lenalidomide 25 mg p.o. day 1-21 * Dexamethasone 40/20 mg p.o., day 1, 8, 15, 22 * Pegfilgrastim 6 mg s.c., day 3 in case of severe neutropenia Maintenance treatment phase (cycles 7-18): * Lenalidomide 25 mg p.o. day 1-21 * Dexamethasone 40/20 mg p.o., day 1, 8, 15, 22

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Mundipharma Research GmbH & Co KG

    collaborator INDUSTRY

  • Mundipharma Medical Company

    collaborator INDUSTRY

  • Amgen

    collaborator INDUSTRY

  • Cantonal Hospital of St. Gallen

    lead OTHER

Principal Investigators

  • Ulrich Mey, MD · Kantonsspital Graubünden

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT01701076 on ClinicalTrials.gov