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.
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 determine the qualitative and quantitative toxicities of BB-10901 administered on this schedule. * To evaluate the pharmacokinetics of BB-10901. * To recommend a dose for Phase II clinical studies with BB-10901 given on this specific regimen. * To observe any evidence of anti-tumor activity with BB-10901. Objectives of MTD Expansion Cohort * To evaluate response rate including overall response rate (ORR) and complete response rate (CRR), and duration of response (DOR). * To further assess time to progression (TTP), progression free survival (PFS), and overall survival (OS). OUTLINE: This is an open-label, non-randomized, dose-escalation, multicenter study. Patients receive BB-10901 IV over 1-2 hours on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of BB-10901 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Up to 40 patients are treated at the MTD. After completion of study treatment, patients are followed for short term follow-up and long term (up to 3 years) survival status. PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
dose escalation study, doses will vary per cohort. patients will receive an IV infusion weekly for two weeks every three weeks.
Cedars-Sinai Outpatient Cancer Center
Los Angeles, California, United States
UCSF
San Francisco, California, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
Roswell Park Cancer Institute
Dose-limiting toxicity
Time frame: through cycle 1
Maximum tolerated dose
Time frame: for the duration of the study
Qualitative and quantitative toxicities
Time frame: for the duration of the study
Pharmacokinetics
Time frame: for the duration of the study
Anti-tumor activity including overall response rate, time to progression and survival
Time frame: for the duration of the study
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Buffalo, New York, United States
St. Vincent's Comprehensive Cancer Center - Manhattan
New York, New York, United States
Juan Domingo Peron 1500 - (B1629AHJ) Pilar
Buenos Aires, Buenos Aires, Argentina
Gascon 450 - (C1181ACH)
Buenos Aires, Buenos Aires F.D., Argentina
Av. Naciones Unidas 346. (X5016KEH)-Barrio Parque Velez Sarfield
Córdoba, Córdoba Province, Argentina