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Bone Marrow Transplant

Melphalan followed by SCT for Multiple Myeloma (FHCRC-2004)
A Multi-center Phase III Study of Autologous Transplantation for Patients with Multiple Myeloma Comparing Melphalan 280 mg/m2 + Amifostine with Melphalan 200 mg/m2 + Amifostine
Status Conditions Phase Study ID
Closed Hematologic Malignancies; Multiple Myeloma (MM) Phase III FHCRC-2004
NCT00217438
Summary

The purpose of this study is to compare the effects of two different dosage levels of melphalan, followed by stem-cell transplantation, in patients with multiple myeloma (MM). One dosage is the standard chemotherapy treatment for MM; the other is the research dosage, and is higher than the standard dosage level. Both dosage levels are very high.

Study participants will be randomly placed into one of two groups, which will determine the dosage level the participant receives. Both groups of participants will also receive a drug called amifostine, which may help protect them from the toxic side effects of the high-dose chemotherapy. Two days after receiving the chemotherapy, both groups of participants will receive a stem-cell transplant.

The study treatment will last about three or four months. During this time, participants will have regularly scheduled physical exams and tests. Participants will be treated initially at the Seattle Cancer Care Alliance outpatient clinic (SCCA) for at least one to two months, then may continue treatment either at the SCCA or at the clinic of the participant?s referring physician.

We would like to follow-up with the participant every three months for at least five years after the transplant.


Investigator
Bill Bensinger, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)

- Patient has multiple myeloma and will be undergoing an autologous or syngeneic hematopoietic stem cell transplantation. Patients must meet Salmon and Durie criteria for initial diagnosis of multiple myeloma as defined by study guidelines. Transplant will be offered to patients with stage II or III MM

 

- Patient is between 18 and 70 years of age.

 

- Patient's heart, lung, liver and kidney function meet study guidelines.

 

- Patient is HIV-negative.

 

- Patients of childbearing potential must be willing to use physician-approved birth control methods.

 

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- Planned tandem autologous/reduced intensity allograft.

 

- Insufficient PBSC for autologous transplant, according to study guidelines.

 

- Prior autologous transplant.

 

- Non-secretory myeloma and patients who are in a complete response after conventional therapy.

 

- Life expectancy is severely limited by other illness.

 

- Uncontrolled infection or HIV-positive.

 

- Uncontrolled arrhythmias or symptomatic cardiac disease.

 

- Symptomatic pulmonary disease.

 

- Pregnant or breastfeeding.

 

Other exclusion criteria may apply.

Last Updated
July 25, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.