Chemotherapy, Holmium Ho 166 DOTMP, and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma

NCT00045136 | Completed Phase 1

• 4 other identifiers: CDR0000256377PONIARD-0102NEORX-0102FHCRC-1704.00
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

refractory multiple myeloma; stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma

Interventions

melphalan DRUG

peripheral blood stem cell transplantation PROCEDURE

holmium Ho 166 DOTMP RADIATION

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of multiple myeloma (MM) * Patients with a prior diagnosis of monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma are eligible if they progressed and met the criteria for diagnosis of MM * No non-secretory MM * No symptomatic MGUS, smoldering MM, or indolent MM * No solitary bone or extramedullary plasmacytoma * No immunoglobulin M myeloma * Prior induction therapy for myeloma required * Responding, stable, or progressive disease after induction therapy, or relapsed disease * Candidate for autologous hematopoietic stem cell transplantation * Prior stem cell mobilization with chemotherapy and growth factors according to institutional procedures * Availability of at least 2,000,000 CD34+ cells/kg PATIENT CHARACTERISTICS: Age * 18 to 70 Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Bilirubin no greater than 2 mg/dL * SGPT no greater than 2 times upper limit of normal * No clinical evidence of amyloidosis of the liver Renal * Creatinine no greater than 2.0 mg/dL * Creatinine clearance at least 45 mL/min * Renal ultrasound normal * No clinical evidence of amyloidosis of the kidney * No urinary obstruction in the renal pelvis, ureter, or bladder outlet by ultrasound Cardiovascular * Ejection fraction at least 50% with no evidence of amyloidosis by echocardiogram * No clinical evidence of amyloidosis of the heart * No uncontrolled arrhythmia * No symptomatic cardiac disease Pulmonary * FEV1, FVC, and DLCO at least 60% * No symptomatic pulmonary disease * No clinical evidence of amyloidosis of the lungs Other * No known allergy to vitamin C or bisphosphonates * No known hypersensitivity to technetium Tc 99m phosphorus radiopharmaceuticals (e.g., technetium Tc 99m-methylene diphosphonate) * No concurrent illness that would severely limit life expectancy * No symptoms, physical findings, or radiographic evidence of cord compression * No clinical evidence of amyloidosis of the autonomic nervous system or gastrointestinal tract * No prior noncompliance in other studies * No other malignancy within the past 5 years except treated indolent skin cancers or carcinoma in situ of the cervix * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * No prior stem cell or bone marrow transplantation * No concurrent maintenance therapy comprising interferon or thalidomide Chemotherapy * See Disease Characteristics Endocrine therapy * See Disease Characteristics * No concurrent maintenance therapy comprising dexamethasone Radiotherapy * No prior cumulative external-beam radiotherapy (EBRT) to more than 20% of bone marrow * No prior cumulative EBRT dose of 30 Gy or more to the spinal cord * No prior radiotherapy to the bladder Surgery * See Disease Characteristics Other * At least 4 weeks since prior investigational agents for MM * At least 4 weeks since other prior experimental therapies for any other condition * No bisphosphonates for at least 4 weeks before study, during study, and for at least 30 days posttransplantation

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Poniard Pharmaceuticals: lead

Study Sites (5)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-0006, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus

Nashville, Tennessee, 37212, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Melphalan; Peripheral Blood Stem Cell Transplantation; holmium-1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetrakis(methylenephosphonic acid)

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Wendy Jenkins

  Poniard Pharmaceuticals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 6, 2002
• First Posted: January 27, 2003
• Study Start: January 1, 2002
• Primary Completion: January 1, 2003
• Last Updated: April 3, 2009

Record last verified: 2009-04

Locations

US (5)