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Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma

NCT00098475 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 452

Last updated 2026-05-12

Study results available
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Summary

This randomized phase III trial studies lenalidomide and low-dose dexamethasone to see how well it works compared to lenalidomide and standard-dose dexamethasone, given with or without thalidomide, in treating patients with multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Lenalidomide and thalidomide may also stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide, thalidomide, and dexamethasone together may kill more cancer cells.

Conditions

  • DS Stage I Multiple Myeloma
  • DS Stage II Multiple Myeloma
  • DS Stage III Multiple Myeloma

Interventions

DRUG

Dexamethasone

Given PO

OTHER

Laboratory Biomarker Analysis

Optional correlative studies

DRUG

Lenalidomide

Given PO

DRUG

Thalidomide

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • S. V Rajkumar · ECOG-ACRIN Cancer Research Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-03
Primary Completion
2008-11-30
Completion
2026-10-23

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00098475 on ClinicalTrials.gov