BB-10901 in Treating Patients With Relapsed and/or Refractory Multiple Myeloma



Status:Archived
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011

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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


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.


We found this trial at
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Boston, Massachusetts 02130
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Elm St,
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Center Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer...
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Los Angeles, California
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500 Parnassus Ave
San Francisco, California 94143
(415) 476-9000
University of California at San Francisco (UCSF) The leading university exclusively focused on health, UC...
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