BB-10901 in Treating Patients With Relapsed and/or Refractory Multiple Myeloma (IMGN901)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00346255|
Recruitment Status : Completed
First Posted : June 29, 2006
Last Update Posted : April 23, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: BB-10901||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00346255
|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|