Brostallicin in Treating Patients With Recurrent or Refractory Multiple Myeloma

• Status: Completed
• Trial end date: 2004-04-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy such as brostallicin use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase I/II trial to study the effectiveness of brostallicin in treating patients who have recurrent or refractory multiple myeloma.

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

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)

Criteria

DISEASE CHARACTERISTICS:

• Confirmed diagnosis of multiple myeloma based on prior or current demonstration of the following criteria*:

• Major criteria:

• Plasmacytoma on tissue biopsy

• Bone marrow plasmacytosis with at least 30% plasma cells

• Monoclonal globulin spike on serum electrophoresis exceeding 3.5 g/dL for IgG peaks or 2.0 g/dL for IgA peaks; greater than 1,000 mg/24hr of kappa or gamma light chain excretion on urine electrophoresis in the absence of amyloidosis

• Minor criteria:

• Bone marrow plasmacytosis with 10% to 30% plasma cells

• Monoclonal globulin spike present but less than levels in major criterion III above

• Lytic bone lesions

• Residual normal immunoglobulin M (IgM) no greater than 0.5 g/dL, IgA no greater than 0.1 g/dL, or IgG no greater than 0.6 g/dL NOTE: *Diagnosis of multiple myeloma requires a minimum of 1 major and 1 minor criterion (I and a together is not sufficient; must be I and b, I and c, I and d; II and b, II and c, II and d; III and a, III and c, III and d) or 3 minor criteria that must include a and b (a, b, and c; a, b, and d)

• Measurable disease defined by 1 of the following values:

• Serum myeloma (M) protein (IgG or IgA) level greater than 1.0 g/dL

• Urine M protein (light chain disease) at least 300 mg/24hr

• Soft tissue plasmacytoma with bidimensional measurement at least 20 x 20 mm (10 x 10 mm if spiral CT scan is used)

• Must have progressed during or within 12 months of discontinuing prior myelosuppressive chemotherapy (e.g., vincristine, doxorubicin, and dexamethasone (VAD) or melphalan) OR not responded after 2 courses of prior myelosuppressive chemotherapy

• No indolent or smoldering myeloma or localized plasmacytoma

• No known brain or leptomeningeal disease unless such lesions were previously irradiated, are currently not being treated with corticosteroids, and are associated with no clinical symptoms

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Eastern Cooperative Oncology Group (ECOG) 0-2

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3 (at least 1,000/mm^3 if neutropenia due to replacement of the normal bone marrow cells by myeloma cells)

• Platelet count at least 100,000/mm^3 (at least 50,000/mm^3 if thrombocytopenia due to replacement of the normal bone marrow cells by myeloma cells)

• Hemoglobin at least 8.0 g/dL (no transfusion allowed)

• No hyperviscosity syndrome

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• Serum glutamate oxaloacetate transaminase (SGOT) no greater than 2.5 times ULN

• Alkaline phosphatase no greater than 2.5 times ULN

Renal

• Creatinine no greater than 3.0 times ULN

• Calcium no greater than 12 mg/dL

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and sampling for study analysis

• HIV negative

• No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix

• No AIDS-related illness

• No active infectious process or other severe concurrent disease that would make the patient inappropriate for study entry

• No mental incapacity or psychiatric illness that would preclude giving informed consent or completing follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Chemotherapy

• No concurrent anticancer biological response modifiers

• No concurrent immunotherapy

• No concurrent sargramostim (GM-CSF)

Chemotherapy

• See Disease Characteristics

• More than 2 years since prior high-dose chemotherapy with autologous bone marrow transplantation or stem cell support

• More than 4 weeks since prior myelosuppressive chemotherapy

• No other concurrent anticancer chemotherapy

Endocrine therapy

• See Disease Characteristics

• No concurrent anticancer hormonal therapy

• No concurrent chronic steroids

• Acute pulse dosing required for treatment of a concurrent medical condition is allowed, provided treatment duration is no greater than 2 weeks

• No concurrent corticosteroids (e.g., dexamethasone)

Radiotherapy

• More than 14 days since prior radiotherapy

• No prior radiotherapy to more than 25% of bone marrow

• No plans for radiotherapy within the next 6 months

• Concurrent palliative radiotherapy for skeletal pain allowed

Surgery

• More than 14 days since prior surgery

• No plans for surgery within the next 6 months

Other

• Acute toxic effects of prior therapy (except for alopecia and neurotoxicity) must have resolved to grade 0, 1, or the patient's baseline

• Treatment-related neurotoxicity must have resolved to the patient's baseline, not to exceed grade 2

• Chronic bisphosphonates for bone pain allowed only for maintenance doses

• More than 2 weeks since prior nonmyelosuppressive antimyeloma therapy

• More than 2 weeks since prior macrolide antibiotics

• No other concurrent investigational agents

• No concurrent macrolide antibiotics

• No concurrent participation in another treatment clinical study