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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

Phase 1
18 Years
Not Enrolling
Multiple Myeloma

Thank you

Trial Information

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



- 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

- 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.

Inclusion Criteria


- Histologically confirmed multiple myeloma

- Relapsed or relapsed/refractory disease

- Failed ≥ 1 prior therapy for multiple myeloma

- Once the MTD is defined, only patients who have received at least 1 but equal or
less than 6 prior chemotherapy regimens will be enrolled at this dose level

- CD56-positive disease confirmed by immunohistochemistry or flow cytometry


- ECOG (Zubrod) performance status 0-2

- Life expectancy ≥ 12 weeks

- Platelet count ≥ 75,000/mm^3

- Absolute neutrophil count > 1,000/mm^3

- Hemoglobin ≥ 8.5 g/dL

- AST and ALT ≤ 3 times upper limit of normal (ULN)

- Bilirubin ≤ 1.5 times ULN

- Amylase and lipase within normal limits

- Creatinine ≤ 2 mg/dL

- Left ventricular ejection fraction ≥ lower limit of normal on MUGA or ECHO

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No peripheral neuropathy ≥ grade 3 or painful grade 2 neuropathy

- No significant cardiac disease, including any of the following:

- Myocardial infarction within the past 6 months

- Unstable angina

- Uncontrolled congestive heart failure

- Uncontrolled hypertension (i.e., recurrent or persistent increases in systolic
blood pressure ≥ 180 mm Hg or diastolic blood pressure ≥ 110 mm Hg)

- Uncontrolled cardiac arrhythmias

- Cardiac toxicity ≥ grade 3 after prior chemotherapy

- No history of multiple sclerosis or other demyelinating disease

- No hemorrhagic or ischemic stroke within the past 6 months

- No Eaton-Lambert syndrome (para-neoplastic syndrome)

- No CNS injury with residual neurological deficit (other than peripheral neuropathy ≤
grade 2)

- No other malignancy within the past 3 years except adequately treated basal cell or
squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, or in situ
prostate cancer

- No clinically relevant active infection, including active hepatitis B or C infection
or HIV infection

- No other condition or disease, including laboratory abnormalities, that, in the
opinion of the investigator, may preclude study treatment

- No known recent biochemical or clinical evidence of pancreatitis or extensive
metastatic disease involving the pancreas


- See Disease Characteristics

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)

- At least 4 weeks since prior radiotherapy

- At least 4 weeks since prior major surgery (except placement of a vascular access
device or tumor biopsies)

- More than 4 weeks since prior investigational agents

- At least 2 weeks since prior antineoplastic therapy with biological agents

- No prior hypersensitivity to monoclonal antibody therapy

- No other concurrent investigational agents

- No concurrent corticosteroids (except as indicated for other medical conditions [< 10
mg prednisone or equivalent]; as pre-medication for administration of certain
medications or blood products [≤ 100 mg hydrocortisone]; or for treatment of infusion

- Concurrent topical steroids allowed

- No other concurrent antineoplastic treatment (e.g., chemotherapy, radiotherapy, or
biological agents)

- Concurrent bisphosphonates allowed provided patient began bisphosphonates before
study entry and is maintained on a stable dose during study treatment

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose-limiting toxicity

Outcome Time Frame:

through cycle 1

Safety Issue:


Principal Investigator

Asher Alban Akmal Chanan-Khan,, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

April 2005

Completion Date:

March 2011

Related Keywords:

  • Multiple Myeloma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



UCSFSan Francisco, California  941430324
Roswell Park Cancer InstituteBuffalo, New York  14263
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
St. Vincent's Comprehensive Cancer Center - ManhattanNew York, New York  10011
Cedars-Sinai Outpatient Cancer CenterLos Angeles, California