Multiple Myeloma Clinical Trial
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
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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