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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Poniard Pharmaceuticals
• Treatments: Melphalan

Criteria

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