Status:
COMPLETED
Melphalan and Amifostine Followed By One or Two Autologous or Syngeneic Stem Cell Transplants and Maintenance Therapy in Treating Patients With Stage II-III Multiple Myeloma
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Refractory Multiple Myeloma
Stage II Multiple Myeloma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
RATIONALE: Giving chemotherapy drugs, 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. Chemoprotective drugs...
Detailed Description
PRIMARY OBJECTIVES: I. Compare the complete response (CR) and near CR rate in patients undergoing autologous stem cell transplant (ASCT) using melphalan 280 mg/m\^2 or melphalan 200 mg/m\^2. SECONDA...
Eligibility Criteria
Inclusion
- Patients who have MM undergoing autologous or syngeneic hematopoietic transplantation
- Patients must meet Salmon and Durie criteria for initial diagnosis of MM
- Transplant will be offered to patients with stage II or III MM
- Measurable disease, defined as serum monoclonal protein \>= 0.2 g/dl or Bence Jones protein \>= 200 mg/24 h
- Karnofsky \>= 70 or Eastern Cooperative Oncology Group (ECOG) 0-2
- Life expectancy is not severely limited by concomitant illness
- Left ventricular ejection fraction \>= 50%
- No uncontrolled arrhythmias or symptomatic cardiac disease
- Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and diffusion capacity of carbon monoxide (DLCO) \>= 50%
- No symptomatic pulmonary disease
- Human immunodeficiency virus (HIV) negative
- Bilirubin \< 2 mg/dl
- Serum glutamic pyruvate transaminase (SGPT) \< 2.5 x normal
- Creatinine clearance \>= 60 cc/min, estimated or measured
- Signed informed consent
Exclusion
- Pregnant or lactating females
- Uncontrolled infection
- Planned tandem autologous/reduced intensity allograft
- Insufficient PBSC for an autologous transplant (\< 3.0 x 10\^6 CD34+ cells/kg total)
- Prior autologous transplant
- Non-secretory myeloma and patients who are in a complete response or near complete response after conventional therapy
- Patients unwilling to practice adequate forms of contraception if clinically indicated
- Male patients on study need to be consulted to use latex condoms, even if they have had a vasectomy, every time they have sex with a woman who is able to have children
- Patients with history of seizures
- Patients receiving antihypertensive therapy that cannot be stopped for 24 hours preceding amifostine treatment
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00217438
Start Date
July 1 2005
Last Update
August 21 2015
Active Locations (4)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
University of Rochester
Rochester, New York, United States, 14642
3
VA Puget Sound Health Care System
Seattle, Washington, United States, 98101
4
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109