BB-10901 in Treating Patients With Relapsed and/or Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma
- Registration Number
- NCT00346255
- Lead Sponsor
- ImmunoGen, Inc.
- 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 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.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Dose-limiting toxicity through cycle 1 Maximum tolerated dose for the duration of the study
- Secondary Outcome Measures
Name Time Method Qualitative and quantitative toxicities for the duration of the study Pharmacokinetics for the duration of the study Anti-tumor activity including overall response rate, time to progression and survival for the duration of the study
Trial Locations
- Locations (8)
Juan Domingo Peron 1500 - (B1629AHJ) Pilar
🇦🇷Buenos Aires, Argentina
St. Vincent's Comprehensive Cancer Center - Manhattan
🇺🇸New York, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Cedars-Sinai Outpatient Cancer Center
🇺🇸Los Angeles, California, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
UCSF
🇺🇸San Francisco, California, United States
Gascon 450 - (C1181ACH)
🇦🇷Buenos Aires, Capital Federal, Argentina
Av. Naciones Unidas 346. (X5016KEH)-Barrio Parque Velez Sarfield
🇦🇷Córdoba, Argentina