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Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant

NCT00114101 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2026-04-29

Study results available
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Summary

This randomized phase III trial studies lenalidomide to see how well it works compared to a placebo in treating patients with multiple myeloma who are undergoing autologous stem cell transplant. Giving chemotherapy before a peripheral blood stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Giving lenalidomide after autologous stem cell transplant may be an effective treatment for multiple myeloma.

Conditions

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

Interventions

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Undergo autologous PBSCT

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Lenalidomide

Given PO

DRUG

Melphalan

Given IV

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo autologous PBSCT

OTHER

Placebo Administration

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Philip L McCarthy · Alliance for Clinical Trials in Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-15
Primary Completion
2012-12-31
Completion
2027-03-06

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 NCT00114101 on ClinicalTrials.gov