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.