Chemotherapy, Holmium Ho 166 DOTMP, and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00045136|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 3, 2009
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Holmium Ho 166 DOTMP may deliver radiation directly to cancer cells and cause less damage to normal tissue. Combining chemotherapy and holmium Ho 166 DOTMP with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and holmium Ho 166 DOTMP and kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining holmium Ho 166 DOTMP with melphalan and peripheral stem cell transplantation in treating patients who have multiple myeloma.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma and Plasma Cell Neoplasm||Drug: melphalan Procedure: peripheral blood stem cell transplantation Radiation: holmium Ho 166 DOTMP||Phase 1 Phase 2|
- 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 tests.
- 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 mathematical model.
- 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 patients.
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Multicenter Dosimetry Trial to Evaluate Radiation Absorbed Dose From Holmium-166-DOTMP in Patients With Multiple Myeloma|
|Study Start Date :||January 2002|
|Actual Primary Completion Date :||January 2003|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00045136
|United States, Alabama|
|University of Alabama at Birmingham Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294-0006|
|United States, California|
|University of California Davis Cancer Center|
|Sacramento, California, United States, 95817|
|United States, Tennessee|
|Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus|
|Nashville, Tennessee, United States, 37212|
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109-1024|
|Principal Investigator:||Wendy Jenkins||Poniard Pharmaceuticals|