CompletedPhase 2

Busulfan, Cyclophosphamide, and Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma

United States71 participantsStarted 2009-06-11

Plain-language summary

RATIONALE: Giving high-dose chemotherapy before an autologous stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. An autologous stem cell transplant may be able to replace the blood-forming cells that were destroyed by the chemotherapy. PURPOSE: This phase II trial is studying how well giving busulfan together with cyclophosphamide followed by an autologous stem cell transplant works in treating patients with multiple myeloma.

Who can participate

Age range

18 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.

INCLUSION CRITERIA: * Patients with a diagnosis of plasma cell myeloma * Patients with cardiac ejection fraction \>= 45% or clearance by Cleveland Clinic Faculty (CCF) cardiologist * Patients with diffusion capacity of carbon monoxide (DLCO) \>= 45% predicted or clearance by CCF pulmonologist * Patient with previously harvested peripheral blood progenitor cells with a minimum of 2 x 10\^6 CD 34+ cells/kg harvested EXCLUSION CRITERIA: * Patients receiving total body irradiation * Non-myeloablative/reduced-intensity conditioning * Pregnant and breast feeding patients * Human immunodeficiency virus (HIV) positive * Patients with serum creatinine \> 2.0 * Prior Hematopoietic Stem Cell (HSC) transplant

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

Relapse-free Survival

Timeframe: at 6 months

Overall Survival

Timeframe: at 6 months

Trial details

NCT IDNCT00941720

SponsorCase Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-02-28

Results submitted2014-02-13

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