CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 460 enrolled / 460 target
Drug / intervention
Lenalidomide +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00114101
NCT00114101Phase 3ActiveUpdate Overdue (1.8/mo)Completion was 161mo ago
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A Phase III Randomized, Double-Blind Study of Maintenance Therapy With CC-5013 (NSC # 703813) or Placebo Following Autologous Stem Cell Transplantation for Multiple Myeloma

National Cancer Institute (NCI)·interventional·Posted Jun 14, 2005·Updated Jun 17, 2026

In Brief

A Phase 3 clinical trial evaluating Autologous Hematopoietic Stem Cell Transplantation, Laboratory Biomarker Analysis, and 4 other interventions for DS Stage I Multiple Myeloma and 4 related conditions. Active but no longer recruiting, targeting 460 participants across 140 sites.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDS Stage I Multiple Myeloma, DS Stage II Multiple Myeloma, DS Stage III Multiple Myeloma, Refractory Multiple Myeloma, Smoldering Multiple Myeloma
CountriesUnited States
Collaborators--

Timeline

Phase 3Active
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 14, 2005
Enrollment StartDec 15, 2004
Primary CompletionDec 31, 2012
Study CompletionMar 6, 2027
TodayJul 2, 2026
Enrollment to primary: 8.0 yearsPosted 21.1 years ago

Arms & Interventions

Arm I (melphalan, autologous PBSCT, lenalidomide)experimental

Beginning between day 100-110, patients receive lenalidomide PO once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Procedure: Autologous Hematopoietic Stem Cell TransplantationOther: Laboratory Biomarker AnalysisDrug: LenalidomideDrug: MelphalanProcedure: Peripheral Blood Stem Cell Transplantation
Arm II (melphalan, autologous PBSCT, placebo)placebo_comparator

Beginning between day 100-110, patients receive placebo PO once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Procedure: Autologous Hematopoietic Stem Cell TransplantationOther: Laboratory Biomarker AnalysisDrug: MelphalanProcedure: Peripheral Blood Stem Cell TransplantationOther: Placebo Administration

Interventions

Autologous Hematopoietic Stem Cell Transplantationprocedure

Undergo autologous PBSCT

Laboratory Biomarker Analysisother

Correlative studies

Lenalidomidedrug

Given PO

Melphalandrug

Given IV

Peripheral Blood Stem Cell Transplantationprocedure

Undergo autologous PBSCT

Placebo Administrationother

Given PO