Lenalidomide + Dexamethasone +/- Bortezomib for Multiple Myeloma
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: National Cancer Institute (NCI)
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This randomized phase III trial studies lenalidomide, dexamethasone, and bortezomib to see how well it works compared to dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the cancer. It is not yet known whether lenalidomide and dexamethasone is more effective with or without bortezomib in treating multiple myeloma.
Eligibility Criteria
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.Inclusion Criteria
I do not have severe heart issues, recent heart attack, uncontrolled infections, high blood pressure, or diabetes.
I can take care of myself, but I might not be able to do heavy physical work.
I can take aspirin daily or a substitute if I'm allergic.
I haven't had radiation to more than half of my pelvis.
I have never had a stroke that left me with lasting brain damage.
My kidney function is good, with a creatinine clearance over 30 cc/min.
I have not received chemotherapy for my current illness.
I have been recently diagnosed with multiple myeloma and it can be measured.
I have never been treated with bortezomib or lenalidomide.
My hemoglobin level is 9 g/dL or higher, even after treatments like transfusions or EPO.
Exclusion Criteria
My multiple myeloma does not produce detectable markers, but my serum Freelite levels are high.
I do not have a performance status of 3 due to other health conditions.
My bone marrow is heavily affected by cancer, with over half of the cells being cancerous.
I have had a stroke and still experience its effects.
I do not have severe heart issues, uncontrolled infections, or poorly managed diabetes.
My multiple myeloma does not show up in standard blood or urine tests.
Treatment Details
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.
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.
Bortezomib is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Velcade for:
- Multiple myeloma
- Mantle cell lymphoma
🇺🇸 Approved in United States as Velcade for:
- Multiple myeloma
- Mantle cell lymphoma
🇨🇦 Approved in Canada as Velcade for:
- Multiple myeloma
- Mantle cell lymphoma
🇯🇵 Approved in Japan as Velcade for:
- Multiple myeloma
- Mantle cell lymphoma
Find a clinic near you
Research locations nearbySelect from list below to view details:
Bozeman Deaconess HospitalBozeman, MT
University of Wisconsin Carbone Cancer Center Johnson CreekJohnson Creek, WI
Saint Joseph Hospital - Cancer Centers of ColoradoDenver, CO
Community Medical HospitalMissoula, MT
More Trial Locations
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Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor