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Immunomodulatory Agent

Melphalan + Prednisone + Thalidomide/Lenalidomide for Multiple Myeloma

Phase 3

Waitlist Available

Led By Alexander K Stewart

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 a confirmed diagnosis of symptomatic myeloma with specific criteria for bone marrow plasmacytosis or biopsy proven plasmacytoma

Patient must have had symptomatic disease at initial diagnosis that prompted the initiation of therapy as well as evidence of end-organ damage at the time of diagnosis

Must not have

Patients with asymptomatic smoldering myeloma and monoclonal gammopathy of undetermined significance are not eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial compares melphalan/prednisone with thalidomide to melphalan/prednisone with lenalidomide to see which is more effective in treating newly diagnosed multiple myeloma.

Who is the study for?

This trial is for patients with newly diagnosed multiple myeloma. Eligible participants are those over 65 who declined alternative treatments, or adults under 65 not suitable for stem cell transplantation. They must have an ECOG performance status of <=2, no severe peripheral neuropathy, uncontrolled illnesses, active infections, or recent malignancies (with exceptions). Women of childbearing age must test negative for pregnancy and follow strict birth control measures.

What is being tested?

The study compares two treatment combinations: melphalan and prednisone with thalidomide versus the same chemotherapy drugs with lenalidomide. The goal is to determine which combination better halts cancer growth by either killing cells or blocking blood flow to them. Participants will be randomly assigned to one of these treatment groups.

What are the potential side effects?

Potential side effects include reactions from chemotherapy like nausea and hair loss; thalidomide may cause drowsiness or nerve damage; lenalidomide can lead to blood clots or fatigue. Both medications could increase the risk of birth defects if taken during pregnancy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with symptomatic myeloma confirmed by bone marrow or biopsy tests.

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I started treatment because my symptoms were affecting my organs when I was first diagnosed.

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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 able to have children, not pregnant, and agree to use birth control.

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I do not have severe numbness or pain in my hands or feet.

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I do not have any ongoing, untreated infections.

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I am willing to take aspirin or another blood thinner as directed.

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I am not pregnant or breastfeeding.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have smoldering myeloma or MGUS without symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-Free Survival (PFS)

Secondary study objectives

Change in Functional Assessment of Cancer Therapy-Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) Score From Baseline to Cycle 12

Overall Survival

Very Good Partial Response (VGPR) Rate

Awards & Highlights

Pivotal Trial

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

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (lenalidomide)Experimental Treatment4 Interventions

INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO QD on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive lenalidomide PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression.

Group II: Arm I (thalidomide)Active Control5 Interventions

INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO QD on days 1-4, and thalidomide PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive thalidomide PO QD and continue in the absence of disease progression.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prednisone

2014

Completed Phase 4

~2500

Lenalidomide

2005

Completed Phase 3

~2240