NCT00346255

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: ImmunoGen, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	BB-10901	dose escalation study, doses will vary per cohort. patients will receive an IV infusion weekly for two weeks every three weeks.

Timeline

• Start date: 2005-04-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2006-06-29
• Last updated: 2013-04-23

Locations

8 sites across 2 countries: United States, Argentina