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Immunomodulatory Agent

Lenalidomide + Melphalan for Multiple Myeloma

Phase 1 & 2
Waitlist Available
Led By Roger Pearse, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have an adequate number of CD34+ stem cells collected to allow for transplantation
Patients must have histologically or cytologically confirmed relapsed, primary refractory, or relapsed and refractory multiple myeloma
Must not have
Patients who have had myeloma therapy within 14 days prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier
Known positive for HIV or infectious hepatitis, type B or C
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until death or a maximum of 3 years, whichever occurs first
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the addition of lenalidomide to standard treatment for multiple myeloma to see if it improves response rates and duration of response.

Who is the study for?
This trial is for adults over 18 with relapsed multiple myeloma who've had at least one prior treatment. They must have measurable disease, adequate organ/marrow function, and a good performance status. Participants need to agree to birth control measures and anticoagulation therapy. Exclusions include recent myeloma therapy, HIV/hepatitis infection, uncontrolled illnesses, pregnancy/lactation, history of thrombosis or allergies to the drugs tested.
What is being tested?
The study aims to find the highest safe dose of lenalidomide combined with high-dose melphalan before stem cell transplantation in Phase 1. In Phase 2, it tests if this combination followed by maintenance lenalidomide can improve response rates and duration in relapsed multiple myeloma patients.
What are the potential side effects?
Potential side effects may include blood disorders (like low white cells/platelets), liver issues (elevated enzymes), heart problems (reduced ejection fraction), kidney impairment (low clearance rate), risk of clotting due to prophylactic anticoagulation therapy, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have enough CD34+ stem cells collected for a transplant.
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My multiple myeloma has come back or did not respond to initial treatment.
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I am 18 years old or older.
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I am able to become pregnant and will use two forms of birth control or abstain from sex.
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I can take low-dose aspirin daily without any issues.
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I have undergone at least one treatment for my condition.
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I can take care of myself but might not be able to do heavy physical work.
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I am willing to take blood thinner medication as required.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had myeloma treatment in the last 14 days and have recovered from any previous treatment side effects.
Select...
I am positive for HIV or hepatitis B/C.
Select...
I do not have any uncontrolled illnesses that could affect my participation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until death or a maximum of 3 years, whichever occurs first
This trial's timeline: 3 weeks for screening, Varies for treatment, and until death or a maximum of 3 years, whichever occurs first for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Duration of overall response (DoR)
Maximum tolerated dose (MTD) of lenalidomide that can be added to melphalan
Secondary study objectives
Mean Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) score
Overall Response Rate
Overall Survival

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: all patientsExperimental Treatment2 Interventions
subjects will receive daily doses of lenalidomide starting on Day -5 of transplant and melphalan on Days -2 and -1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
melphalan
1994
Completed Phase 3
~3530
lenalidomide
2012
Completed Phase 3
~3370

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,091 Previous Clinical Trials
1,154,693 Total Patients Enrolled
19 Trials studying Multiple Myeloma
614 Patients Enrolled for Multiple Myeloma
CelgeneIndustry Sponsor
645 Previous Clinical Trials
130,131 Total Patients Enrolled
146 Trials studying Multiple Myeloma
41,754 Patients Enrolled for Multiple Myeloma
Roger Pearse, MDPrincipal InvestigatorWeill Medical College of Cornell University

Media Library

Lenalidomide (Immunomodulatory Agent) Clinical Trial Eligibility Overview. Trial Name: NCT01054196 — Phase 1 & 2
Multiple Myeloma Research Study Groups: all patients
Multiple Myeloma Clinical Trial 2023: Lenalidomide Highlights & Side Effects. Trial Name: NCT01054196 — Phase 1 & 2
Lenalidomide (Immunomodulatory Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01054196 — Phase 1 & 2
~3 spots leftby Dec 2025
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