BB-10901 in Treating Patients With Relapsed and/or Refractory Multiple Myeloma (IMGN901)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study to Assess The Safety and Pharmacokinetics of BB-10901 (huN901-DM1) Given as an Intravenous Infusion Weekly for Two Consecutive Weeks Every Three Weeks to Subjects With Relapsed and Relapsed Refractory CD56-Positive Multiple Myeloma|
- Dose-limiting toxicity [ Time Frame: through cycle 1 ] [ Designated as safety issue: Yes ]
- Maximum tolerated dose [ Time Frame: for the duration of the study ] [ Designated as safety issue: Yes ]
- Qualitative and quantitative toxicities [ Time Frame: for the duration of the study ] [ Designated as safety issue: Yes ]
- Pharmacokinetics [ Time Frame: for the duration of the study ] [ Designated as safety issue: No ]
- Anti-tumor activity including overall response rate, time to progression and survival [ Time Frame: for the duration of the study ] [ Designated as safety issue: No ]
|Study Start Date:||April 2005|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
- Determine the dose-limiting toxicity and the maximum tolerated dose of BB-10901 in patients with relapsed and/or refractory CD56-positive multiple myeloma.
- 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.
|United States, California|
|Cedars-Sinai Outpatient Cancer Center|
|Los Angeles, California, United States|
|San Francisco, California, United States, 94143|
|United States, Massachusetts|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|St. Vincent's Comprehensive Cancer Center - Manhattan|
|New York, New York, United States, 10011|
|Gascon 450 - (C1181ACH)|
|Buenos Aires, Capital Federal, Argentina|
|Juan Domingo Peron 1500 - (B1629AHJ) Pilar|
|Buenos Aires, Argentina|
|Av. Naciones Unidas 346. (X5016KEH)-Barrio Parque Velez Sarfield|
|Principal Investigator:||Asher Alban Akmal Chanan-Khan,, M.D.||Roswell Park Cancer Institute|