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NCT00114101 · ClinicalTrials.gov record · last posted 2026-08-26

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

StatusActive, Not Recruiting
PhasePhase 3
Started2004-12-15
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Amendment record 299 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 299 times since 2005-06-23; most recent amendment 2026-07-01. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2013-07-02
Status change Completed→Active, Not Recruitingv199
2013-05-28
Status change Active, Not Recruiting→Completedv198
2009-07-04
Status change Recruiting→Active, Not Recruitingv190
2009-06-17
Status change Active, Not Recruiting→Recruitingv188
2009-06-11
Status change Recruiting→Active, Not Recruitingv187
Trial Details
NCT Number NCT00114101
Lead Sponsor National Cancer Institute (NCI)
Conditions DS Stage I Multiple Myeloma, DS Stage II Multiple Myeloma, DS Stage III Multiple Myeloma, Refractory Multiple Myeloma, Smoldering Multiple Myeloma
Enrollment 460 participants
Start Date 2004-12-15
Primary Completion 2012-12-31 (estimated)
Study Completion 2027-03-06 (estimated)
Updated on ClinicalTrials.gov 2026-08-26