Radiation Therapy Using Holmium Ho 166 DOTMP Plus Melphalan 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. Identifier: NCT00004158
Recruitment Status : Completed
First Posted : July 19, 2004
Last Update Posted : September 21, 2010
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center

Brief Summary:

RATIONALE: Radiation therapy using holmium Ho 166 DOTMP may damage cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells.

PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy using holmium Ho 166 DOTMP plus 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

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 1999
Actual Study Completion Date : January 2006

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00004158

United States, Florida
Sylvester Cancer Center, University of Miami
Miami, Florida, United States, 33136
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
University of Washington School of Medicine
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Study Chair: William I. Bensinger, MD Fred Hutchinson Cancer Research Center Identifier: NCT00004158     History of Changes
Other Study ID Numbers: 1442.00
CDR0000067396 ( Registry Identifier: PDQ )
First Posted: July 19, 2004    Key Record Dates
Last Update Posted: September 21, 2010
Last Verified: September 2010

Keywords provided by Fred Hutchinson Cancer Research Center:
refractory multiple myeloma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs