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A Study of Low Dose Lenalidomide and Dexamethasone in Relapsed/Refractory Myeloma in Patients at High Risk for Myelosuppression

NCT00482261 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-11-08

No results posted yet for this study

Summary

The purpose of this study is to see whether combination of low dose lenalidomide(10mg)+ dexamethasone is equally effective in treating relapsed/refractory myeloma in the group of elderly patients and other patients at risk of myelosuppression, whilst producing less side effects, especially myelosuppression compared to the higher dose of lenalidomide of 25mg used in the MM-009 and MM-010 trials.

Conditions

Interventions

DRUG

Lenalidomide

15mg daily, days 1-21 of a 28 day cycle for 4 cycles. Patients who get stable disease or better will then receive 15mg on days 1-21 from cycle 5 onwards

DRUG

dexamethasone

20mg day 1-4, 9-12, 17-20 for 4 cycles. Patients who get stable disease or better will then get dexamethasone 20mg on days 1-4 of a 28 day cycle, from cycle 5 onwards

DRUG

aspirin

100mg/day

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Peter MacCallum Cancer Centre, Australia

    lead OTHER

Principal Investigators

  • Miles H Prince, MD · Peter MacCallum Cancer Centre, Australia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2010-08-31
Completion
2014-02-28

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs
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 NCT00482261 on ClinicalTrials.gov