CompletedPhase 3

SWOG-9321 Melphalan, TBI, and Transplant vs Combo Chemo in Untreated Myeloma

United States899 participantsStarted 1994-01

Plain-language summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy and radiation therapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and radiation therapy and kill more cancer cells. It is not yet known which treatment regimen is more effective for multiple myeloma. PURPOSE: Randomized phase III trial to compare the effectiveness of melphalan, total-body irradiation, and peripheral stem cell transplantation with that of combination chemotherapy in treating patients who have previously untreated multiple myeloma.

Who can participate

Age range

18 Years – 70 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: * Newly diagnosed, active multiple myeloma of any stage requiring treatment * Smoldering myeloma (Durie-Salmon stage I) must have a 25% or greater increase in M component levels and/or Bence-Jones protein excretion or development of symptoms * Quantifiable M component of IgG, IgA, IgD, IgE, and/or urinary kappa or lambda light chain (Bence-Jones protein) excretion required * Plasmacytosis of at least 30% allowed for non-secretory disease or secretory disease without quantifiable protein * IgM peaks excluded * Evaluation of siblings as potential allogeneic bone marrow transplant donors required for patients 55 years of age and younger (As of 8/1/97, permanently closed) * HLA followed by DR and MLC testing required * Renal failure, even on dialysis, eligible provided: * Cause is attributed to myeloma (Bence-Jones protein or hypercalcemia) * Duration does not exceed 2 months * If medically appropriate, the following conditions should be treated prior to registration: * Pathologic fractures * Pneumonia at diagnosis * Hyperviscosity with shortness of breath PATIENT CHARACTERISTICS: Age: * 70 and under Performance status: * SWOG 0-2 (SWOG 3 or 4 based solely on bone pain allowed) Hematopoietic: * Not specified Hepatic: * Not specified Renal: * See Disease Characteristics Cardiovascular: * Normal ejection fraction by ECHO or MUGA * No myocardial infarction within 6 months * No unstable angina * No difficult to control con…

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

survival

Timeframe: 3 years from randomization

Trial details

NCT IDNCT00002548

SponsorSWOG Cancer Research Network

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2003-10

View on ClinicalTrials.gov More Multiple Myeloma trials