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

NCT ID: NCT00346255

Last Updated: 2013-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2011-03-31

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

BB-10901

dose escalation study, doses will vary per cohort. patients will receive an IV infusion weekly for two weeks every three weeks.

Intervention Type: DRUG

Other Intervention Names

IMGN901

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

• 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

PRIOR CONCURRENT THERAPY:

• 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 reactions)

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ImmunoGen, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Cedars-Sinai Outpatient Cancer Center

Los Angeles, California, United States

UCSF

San Francisco, California, United States

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

St. Vincent's Comprehensive Cancer Center - Manhattan

New York, New York, United States

Juan Domingo Peron 1500 - (B1629AHJ) Pilar

Buenos Aires, Buenos Aires, Argentina

Gascon 450 - (C1181ACH)

Buenos Aires, Buenos Aires F.D., Argentina

Av. Naciones Unidas 346. (X5016KEH)-Barrio Parque Velez Sarfield

Córdoba, Córdoba Province, Argentina

Countries

United States; Argentina

Other Identifiers

IMMUNO-003

Identifier Type: -

Identifier Source: secondary_id

DFCI-05031

Identifier Type: -

Identifier Source: secondary_id

CDR0000491241

Identifier Type: -

Identifier Source: org_study_id

NCT00625508

Identifier Type: -

Identifier Source: nct_alias