CompletedPhase 2

Lenalidomide and Melphalan in Treating Patients With Previously Untreated Multiple Myeloma

Canada51 participantsStarted 2006-03-09

Plain-language summary

RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with melphalan may kill more cancer cells. PURPOSE: This randomized phase II trial is studying the side effects and best dose of lenalidomide when given together with melphalan and to see how well they work in treating patients with multiple myeloma.

Who can participate

Age range

18 Years – 120 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

DISEASE CHARACTERISTICS: * Histologically confirmed multiple myeloma by one of the following: * Biopsy of an osteolytic lesion or soft tissue tumor composed of plasma cells * Bone marrow aspirate and/or biopsy demonstrating ≥ 10% plasmacytosis * Bone marrow \< 10% plasma cells but with ≥ 1 bony lesion AND meets the M-protein criteria * Ineligible for stem cell transplantation due to any of the following: * Advanced age * Comorbid illness * Patient preference * Previously untreated disease * Measurable (i.e., quantifiable) serum M-component of IgG, IgA, IgD, or IgE at initial diagnosis OR, if only light-chain disease is present (urine M-protein only), urinary excretion of light-chain protein (Bence Jones) ≥ 1.0 g/24 hours at initial diagnosis * No nonsecretory myeloma PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 12 months * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 150,000/mm\^3 * Creatinine ≤ 3 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * AST and/or ALT ≤ 1.5 times ULN * Alkaline phosphatase ≤ 1.5 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 2 methods of effective contraception during and for 4 weeks after completion of study treatment * No other malignancies within the past 5 years, except adequately treated nonmelanoma skin cancer or curatively treated in situ cancer of the cervix * No hypersensitivity to thalidomide or its components, including…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of dose-limiting toxicity within first 3 courses of treatment

Trial details

NCT IDNCT00305812

SponsorNCIC Clinical Trials Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2008-06-30

View on ClinicalTrials.gov More Multiple Myeloma and Plasma Cell Neoplasm trials