A Phase I/II Study of Targeted Radiotherapy Using Holmium-166-DOTMP With Melphalan and Peripheral Blood Stem Cell Transplantation for Treatment of Multiple Myeloma
18 Years
65 Years
Both
Multiple Myeloma and Plasma Cell Neoplasm
Trial Information
A Phase I/II Study of Targeted Radiotherapy Using Holmium-166-DOTMP With Melphalan and Peripheral Blood Stem Cell Transplantation for Treatment of Multiple Myeloma
OBJECTIVES: I. Determine the maximum tolerated dose of targeted radiotherapy using holmium
Ho 166 DOTMP when combined with melphalan and autologous or syngeneic peripheral blood stem
cell transplantation in patients with multiple myeloma. II. Determine the response rate and
time to progression in patients treated with this regimen.
OUTLINE: This is a dose escalation, multicenter study of targeted radiotherapy using holmium
Ho 166 DOTMP. Phase I: Autologous or syngeneic peripheral blood stem cells (PBSC) are
harvested and selected for CD34+ cells. Patients receive an initial test dose of holmium Ho
166 DOTMP IV. Patients with adequate skeletal uptake of the test dose then receive
therapeutic dose holmium Ho 166 DOTMP IV over 5-10 minutes for 1-3 days beginning 2 days
after test dose infusion and melphalan IV over 20-30 minutes on day -3. PBSC are reinfused
beginning a minimum of 24 hours after melphalan infusion and after ongoing radiation to bone
marrow falls to less than 1 rad/hour. Cohorts of 4-7 patients receive escalating doses of
targeted radiotherapy using holmium Ho 166 DOTMP until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose preceding that at which 2 of 7 patients
experience dose limiting toxicity. Phase II: Patients receive holmium Ho 166 DOTMP at the
MTD from phase I of the study. Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 1 year.
Inclusion Criteria
DISEASE CHARACTERISTICS: Multiple myeloma with one of the following: Complete or partial
response to initial chemotherapy OR Primary refractory disease OR Chemotherapy responsive
relapse Undergoing autologous or syngeneic peripheral blood stem cell transplantation No
myeloma in refractory relapse
PATIENT CHARACTERISTICS: Age: 18 to physiologic 65 Performance status: Zubrod 0-2 Life
expectancy: Not severely limited by concurrent illness Hematopoietic: Not specified
Hepatic: Bilirubin less than 2 mg/dL SGPT less than 4 times normal Renal: Creatinine
clearance at least 30 mL/min Cardiovascular: No uncontrolled arrhythmias or symptomatic
cardiac disease Pulmonary: No symptomatic pulmonary disease FEV1, FVC, and DLCO at least
50% of predicted Other: Not pregnant or nursing Fertile patients must use effective
contraception HIV negative No spinal cord compression
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics Endocrine therapy: Not specified Radiotherapy: Prior external beam
radiotherapy not to exceed 30 Gy to spinal cord or greater than 20% of bone marrow volume
Surgery: Not specified Other: At least 1 month since prior bisphosphonates No other
concurrent experimental agents
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
William I. Bensinger, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Fred Hutchinson Cancer Research Center
Authority:
United States: Federal Government
Study ID:
1442.00
NCT ID:
NCT00004158
Start Date:
June 1999
Completion Date:
January 2006
Related Keywords:
- Multiple Myeloma and Plasma Cell Neoplasm
- refractory multiple myeloma
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| Sylvester Cancer Center, University of Miami | Miami, Florida 33136 |
| University of Washington School of Medicine | Seattle, Washington 98195 |
