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Proteasome Inhibitor

Lenalidomide + Dexamethasone +/- Bortezomib for Multiple Myeloma

Phase 3

Waitlist Available

Led By Brian M Durie

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 not have uncontrolled, active infection requiring intravenous antibiotics, New York Heart Association (NYHA) class III or class IV heart failure, myocardial infarction within the last 6 months, history of treatment for clinically significant ventricular cardiac arrhythmias, poorly controlled hypertension, or poorly controlled diabetes mellitus

Patients must have a Zubrod performance status (PS) of 0 - 3

Must not have

Patients with non-secretory MM will be eligible only if the baseline serum Freelite is elevated (Note that serum Freelite must be drawn; serum light chains are not acceptable)

Patients with PS 3 due to other concurrent medical conditions are not eligible for this trial

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial looks at a new way to treat multiple myeloma by combining lenalidomide, dexamethasone, and bortezomib.

Who is the study for?

This trial is for adults with newly diagnosed multiple myeloma who haven't had treatment before. They need to have enough healthy blood cells, no serious heart conditions, infections or other health issues that could interfere with the study. Women of childbearing age must test negative for pregnancy and agree to contraception.

What is being tested?

The study compares two treatments: one group receives Lenalidomide and Dexamethasone; another gets these plus Bortezomib. It aims to find out which combination is more effective in stopping cancer growth by either killing cells or preventing them from dividing.

What are the potential side effects?

Possible side effects include fatigue, risk of infection due to low blood cell counts, nerve damage (neuropathy), gastrointestinal symptoms like nausea or constipation, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I do not have severe heart issues, recent heart attack, uncontrolled infections, high blood pressure, or diabetes.

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I can take care of myself, but I might not be able to do heavy physical work.

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I can take aspirin daily or a substitute if I'm allergic.

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I haven't had radiation to more than half of my pelvis.

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I have never had a stroke that left me with lasting brain damage.

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My kidney function is good, with a creatinine clearance over 30 cc/min.

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I have not received chemotherapy for my current illness.

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I have been recently diagnosed with multiple myeloma and it can be measured.

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I have never been treated with bortezomib or lenalidomide.

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My hemoglobin level is 9 g/dL or higher, even after treatments like transfusions or EPO.

Exclusion Criteria

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

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My multiple myeloma does not produce detectable markers, but my serum Freelite levels are high.

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I do not have a performance status of 3 due to other health conditions.

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My bone marrow is heavily affected by cancer, with over half of the cells being cancerous.

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I have had a stroke and still experience its effects.

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I do not have severe heart issues, uncontrolled infections, or poorly managed diabetes.

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My multiple myeloma does not show up in standard blood or urine tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years 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

Secondary study objectives

Overall Survival

Response Rates ()

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (dexamethasone, lenalidomide, bortezomib)Experimental Treatment4 Interventions

Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (dexamethasone and lenalidomide)Active Control3 Interventions

Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2650

Bortezomib

2005

Completed Phase 3

~1410