BB-10901 in Treating Patients With Relapsed and/or Refractory Multiple Myeloma (IMGN901)

April 22, 2013 updated by: ImmunoGen, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Juan Domingo Peron 1500 - (B1629AHJ) Pilar
      • Córdoba, Argentina
        • Av. Naciones Unidas 346. (X5016KEH)-Barrio Parque Velez Sarfield
    • Capital Federal
      • Buenos Aires, Capital Federal, Argentina
        • Gascon 450 - (C1181ACH)
  • United States
    • California
      • Los Angeles, California, United States
        • Cedars-Sinai Outpatient Cancer Center
      • San Francisco, California, United States, 94143
        • UCSF
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
    • New York
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10011
        • St. Vincent's Comprehensive Cancer Center - Manhattan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose-limiting toxicity
Time Frame: through cycle 1
through cycle 1
Maximum tolerated dose
Time Frame: for the duration of the study
for the duration of the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Qualitative and quantitative toxicities
Time Frame: for the duration of the study
for the duration of the study
Pharmacokinetics
Time Frame: for the duration of the study
for the duration of the study
Anti-tumor activity including overall response rate, time to progression and survival
Time Frame: for the duration of the study
for the duration of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ImmunoGen, Inc.

Investigators

  • Principal Investigator: Asher Alban Akmal Chanan-Khan,, M.D., Roswell Park Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

June 28, 2006

First Submitted That Met QC Criteria

June 28, 2006

First Posted (Estimate)

June 29, 2006

Study Record Updates

Last Update Posted (Estimate)

April 23, 2013

Last Update Submitted That Met QC Criteria

April 22, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000491241
  • IMMUNO-003
  • DFCI-05031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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