← Back to Search

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

Pivotal Trial

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

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Select...

My lungs work well enough to breathe without symptoms.

Select...

My multiple myeloma is active and needs treatment, and I've responded to initial therapy.

Select...

I have not had any blood, bone marrow, or organ transplant.

Select...

I do not have any serious infections right now.

Select...

My heart pumps well, with an ejection fraction of 40% or higher.

Select...

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)

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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