Status:
COMPLETED
BB-10901 in Treating Patients With Relapsed and/or Refractory Multiple Myeloma
Lead Sponsor:
ImmunoGen, Inc.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Detailed Description
OBJECTIVES: Primary * Determine the dose-limiting toxicity and the maximum tolerated dose of BB-10901 in patients with relapsed and/or refractory CD56-positive multiple myeloma. Secondary * To det...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00346255
Start Date
April 1 2005
End Date
March 1 2011
Last Update
April 23 2013
Active Locations (8)
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1
Cedars-Sinai Outpatient Cancer Center
Los Angeles, California, United States
2
UCSF
San Francisco, California, United States, 94143
3
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
4
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001