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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ duration of study (up to 10years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of study (up to 10years)
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
13,842 Previous Clinical Trials
41,002,540 Total Patients Enrolled
590 Trials studying Multiple Myeloma
188,897 Patients Enrolled for Multiple Myeloma
Philip L McCarthyPrincipal InvestigatorAlliance for Clinical Trials in Oncology
1 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or restricted in physically strenuous activity but can do light work.My lungs work well enough to breathe without symptoms.My multiple myeloma is active and needs treatment, and I've responded to initial therapy.I started my first cancer treatment less than a year ago.I have collected the required number of stem cells for my treatment.My cancer did not worsen after my first treatment, and I've had no more than two treatment plans.I am not pregnant or nursing and will follow strict birth control measures if of childbearing age.I have not had any blood, bone marrow, or organ transplant.I do not have any serious infections right now.My heart pumps well, with an ejection fraction of 40% or higher.I have had less than a year of treatment, including specific medications.My diabetes is under control.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (melphalan, autologous PBSCT, lenalidomide)
- Group 2: Arm II (melphalan, autologous PBSCT, placebo)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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