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Lenalidomide for Multiple Myeloma

Phase 3
Waitlist Available
Led By Philip L McCarthy
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Patients must have diffusing capacity of the lung for carbon monoxide (DLCO) > 50% predicted with no symptomatic pulmonary disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of study (up to 10years)
Awards & highlights

Summary

This trial compares lenalidomide to a placebo in treating patients with multiple myeloma who are undergoing autologous stem cell transplant.

Who is the study for?
This trial is for patients with active multiple myeloma who need treatment and have responded to at least 2 months of induction therapy. They should not have had more than 12 months of prior treatments, no previous transplants, and must be able to collect enough stem cells for the procedure. Participants need good heart and lung function, controlled diabetes if present, no serious infections or HIV/Hepatitis B/C. Women of childbearing age must test negative for pregnancy and use two forms of birth control.
What is being tested?
The study tests whether lenalidomide improves outcomes in multiple myeloma patients after an autologous stem cell transplant compared to a placebo. Patients receive chemotherapy followed by their own previously collected stem cells to restore bone marrow function. Lenalidomide aims to boost the immune system against cancer cells post-transplant.
What are the potential side effects?
Lenalidomide may cause blood disorders (like low white blood cell counts), fatigue, digestive issues (such as diarrhea or constipation), rash or itching, muscle cramps, and increased risk of infection or secondary cancers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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My lungs work well enough to breathe without symptoms.
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My multiple myeloma is active and needs treatment, and I've responded to initial therapy.
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I have not had any blood, bone marrow, or organ transplant.
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I do not have any serious infections right now.
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My heart pumps well, with an ejection fraction of 40% or higher.
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My diabetes is under control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of study (up to 10years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of study (up to 10years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to Progression
Secondary study objectives
Response to Autologous Hematopoietic Stem-cell Transplant (HSCT) at Day 100
Other study objectives
Overall Survival

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (melphalan, autologous PBSCT, lenalidomide)Experimental Treatment5 Interventions
Beginning between day 100-110, patients receive lenalidomide PO once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (melphalan, autologous PBSCT, placebo)Placebo Group5 Interventions
Beginning between day 100-110, patients receive placebo PO once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melphalan
2008
Completed Phase 3
~1500
Autologous Hematopoietic Stem Cell Transplantation
2017
Completed Phase 3
~2090
Peripheral Blood Stem Cell Transplantation
1997
Completed Phase 3
~1330
Lenalidomide
2005
Completed Phase 3
~1340

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,868 Previous Clinical Trials
41,010,377 Total Patients Enrolled
590 Trials studying Multiple Myeloma
188,895 Patients Enrolled for Multiple Myeloma
Philip L McCarthyPrincipal InvestigatorAlliance for Clinical Trials in Oncology
1 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

Autologous Hematopoietic Stem Cell Transplantation Clinical Trial Eligibility Overview. Trial Name: NCT00114101 — Phase 3
Multiple Myeloma Research Study Groups: Arm I (melphalan, autologous PBSCT, lenalidomide), Arm II (melphalan, autologous PBSCT, placebo)
Multiple Myeloma Clinical Trial 2023: Autologous Hematopoietic Stem Cell Transplantation Highlights & Side Effects. Trial Name: NCT00114101 — Phase 3
Autologous Hematopoietic Stem Cell Transplantation 2023 Treatment Timeline for Medical Study. Trial Name: NCT00114101 — Phase 3
~22 spots leftby Oct 2025