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Study of Bendamustine, Velcade and Dexamethasone in the Treatment of Elderly Patients With Multiple Myeloma

NCT01045681 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2020-12-07

No results posted yet for this study

Summary

The present trial is designed as a phase II study that aims at estimating the efficacy of the combination of bendamustine, bortezomib and dexamethasone in relapsed/refractory multiple myeloma (MM). The response rate, i.e. the rate of the patients achieving a Complete Response or Partial Response at cycle 4, divided by the total intent to treat patient number is chosen as primary efficacy endpoint.

The estimation of the efficacy rate is to be based on an explorative pilot study, since immediate embarking on a large-scale comparative efficacy trial would not be acceptable from the point of view of resources. Moreover, this would induce ethical objections, as it does not seem to be justifiable to expose a large number of patients to an experimental approach without sufficient exploratory indications of an improved risk-benefit ratio.

Conditions

Interventions

DRUG

Bendamustine, Velcade and Dexamethasone

Bendamustine : 70 mg/m2 iv on D1 and 8, for each cycle Velcade : 1.3 mg/m2 iv on D1, 8, 15 and 22, for each cycle Dexamethasone : 20 mg/day po on D1, 8, 15 and 22, given prior to Bendamustine and Velcade

Sponsors & Collaborators

  • Intergroupe Francophone du Myelome

    lead NETWORK

Principal Investigators

  • Philippe RODON, Doctor · Unité Hématologie Biologique Institut Curie PARIS

  • Cyrille HULIN, Doctor · Service Hématologie Hôpitaux de Brabois VANDOEUVRE LES NANCY

  • Jean-Luc HAROUSSEAU, Professor · Service Hématologie CHU Nantes

  • Claire MATHIOT, Doctor · IFM Hématologie Biologique Institut Curie PARIS

  • Marie-Odile PETILLON, Doctor · IFM Hôpital Claude Huriez Lille

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-03
Primary Completion
2013-03-28
Completion
2013-03-28

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

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 NCT01045681 on ClinicalTrials.gov