A Multicenter Dosimetry Trial to Evaluate Radiation Absorbed Dose From Holmium-166-DOTMP in Patients With Multiple Myeloma
- Determine the radiation absorbed dose of holmium Ho 166 DOTMP to the kidney in patients
with multiple myeloma, based on whole body gamma camera image data for comparison with
that obtained using an ICRP mathematical model.
- Determine the average marrow dose of this drug in these patients using gamma camera
whole body counts in patients receiving this drug.
- Determine the pharmacokinetics of this drug in these patients.
- Compare marrow dose estimates determined from gamma camera whole-body counts and
thyroid uptake probe counts in patients receiving this drug.
- Evaluate intra-patient variability of the uptake of this drug in the bone with repeat
- Determine whether the biodistribution and dosimetry is influenced by administering this
drug as a bolus compared to a 15-minute infusion in these patients.
- Compare the reduction in dose rate from the 15-minute infusion vs the bolus injection
of this drug to estimate the effect on kidney exposure in these patients.
- Determine the renal transit time for each patient after bolus injection of this drug
and assess whether this information improves the dose estimate to kidney with the
- Determine whether there is correlation of renal transit time from technetium Tc
99m-diethylenetriaminepentaacetic acid (DTPA) with holmium Ho 166 DOTMP.
- Determine the adverse events in patients receiving this drug.
- Determine the efficacy of a targeted therapy dose of holmium Ho 166 DOTMP with
melphalan followed by autologous peripheral blood stem cell transplantation in these
OUTLINE: This is a multicenter study. Patients are entered into one of two cohorts.
- Cohort A: Patients receive a diagnostic dose of holmium Ho 166 DOTMP IV over 15 minutes
on day 1 and then IV bolus on day 8.
- Cohort B: Patients receive a diagnostic dose of holmium Ho 166 DOTMP IV over 15 minutes
on days 1 and 8.
After each diagnostic dose, patients in both cohorts also undergo gamma camera imaging of
the whole body on days 1 and 8.
Approximately 1-3 weeks later, patients in both cohorts who demonstrate adequate uptake of
the first diagnostic dose of holmium Ho 166 DOTMP into the bone marrow then receive
therapeutic holmium Ho 166 DOTMP IV over 15 minutes once between days -13 to -10 followed by
melphalan IV over 20-30 minutes once between days -10 to -1. Patients undergo autologous
peripheral blood stem cell transplantation on day 0.
Patients are followed monthly for 1 year and then every 3 months for 1 year.
PROJECTED ACCRUAL: A minimum of 12 patients (6 per cohort) will be accrued for this study.
Primary Purpose: Treatment
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|University of Alabama at Birmingham Comprehensive Cancer Center||Birmingham, Alabama 35294-3300|
|University of California Davis Cancer Center||Sacramento, California 95817|
|Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus||Nashville, Tennessee 37212|