BB-10901 in Treating Patients With Relapsed and/or Refractory Multiple Myeloma (IMGN901)
Multiple Myeloma

About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
Eligibility 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
Sites / Locations
- Cedars-Sinai Outpatient Cancer Center
- UCSF
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- Roswell Park Cancer Institute
- St. Vincent's Comprehensive Cancer Center - Manhattan
- Gascon 450 - (C1181ACH)
- Juan Domingo Peron 1500 - (B1629AHJ) Pilar
- Av. Naciones Unidas 346. (X5016KEH)-Barrio Parque Velez Sarfield