BB-10901 in Treating Patients With Relapsed and/or Refractory Multiple Myeloma

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Monoclonal antibodies, such as BB-10901, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.

PURPOSE: This phase I trial is studying the side effects and best dose of BB-10901 in treating patients with relapsed and/or refractory multiple myeloma.

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

Details

• Lead Sponsor: ImmunoGen, Inc.
• Treatments: Lorvotuzumab mertansine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed multiple myeloma

• Relapsed or relapsed/refractory disease

• Failed ≥ 1 prior therapy for multiple myeloma

• Once the MTD is defined, only patients who have received at least 1 but equal or less than 6 prior chemotherapy regimens will be enrolled at this dose level

• CD56-positive disease confirmed by immunohistochemistry or flow cytometry

PATIENT CHARACTERISTICS:

• ECOG (Zubrod) performance status 0-2

• Life expectancy ≥ 12 weeks

• Platelet count ≥ 75,000/mm^3

• Absolute neutrophil count > 1,000/mm^3

• Hemoglobin ≥ 8.5 g/dL

• AST and ALT ≤ 3 times upper limit of normal (ULN)

• Bilirubin ≤ 1.5 times ULN

• Amylase and lipase within normal limits

• Creatinine ≤ 2 mg/dL

• Left ventricular ejection fraction ≥ lower limit of normal on MUGA or ECHO

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No peripheral neuropathy ≥ grade 3 or painful grade 2 neuropathy

• No significant cardiac disease, including any of the following:

• Myocardial infarction within the past 6 months

• Unstable angina

• Uncontrolled congestive heart failure

• Uncontrolled hypertension (i.e., recurrent or persistent increases in systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≥ 110 mm Hg)

• Uncontrolled cardiac arrhythmias

• Cardiac toxicity ≥ grade 3 after prior chemotherapy

• No history of multiple sclerosis or other demyelinating disease

• No hemorrhagic or ischemic stroke within the past 6 months

• No Eaton-Lambert syndrome (para-neoplastic syndrome)

• No CNS injury with residual neurological deficit (other than peripheral neuropathy ≤ grade 2)

• No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, or in situ prostate cancer

• No clinically relevant active infection, including active hepatitis B or C infection or HIV infection

• No other condition or disease, including laboratory abnormalities, that, in the opinion of the investigator, may preclude study treatment

• No known recent biochemical or clinical evidence of pancreatitis or extensive metastatic disease involving the pancreas

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)

• At least 4 weeks since prior radiotherapy

• At least 4 weeks since prior major surgery (except placement of a vascular access device or tumor biopsies)

• More than 4 weeks since prior investigational agents

• At least 2 weeks since prior antineoplastic therapy with biological agents

• No prior hypersensitivity to monoclonal antibody therapy

• No other concurrent investigational agents

• No concurrent corticosteroids (except as indicated for other medical conditions [< 10 mg prednisone or equivalent]; as pre-medication for administration of certain medications or blood products [≤ 100 mg hydrocortisone]; or for treatment of infusion reactions)

• Concurrent topical steroids allowed

• No other concurrent antineoplastic treatment (e.g., chemotherapy, radiotherapy, or biological agents)

• Concurrent bisphosphonates allowed provided patient began bisphosphonates before study entry and is maintained on a stable dose during study treatment