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Status:

COMPLETED

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

Lead Sponsor:

ImmunoGen, Inc.

Conditions:

Multiple Myeloma

Eligibility:

All Genders

18+ years

Phase:

PHASE1

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...

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 det...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    April 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2011

    Estimated Enrollment :

    37 Patients enrolled

    Trial Details

    Trial ID

    NCT00346255

    Start Date

    April 1 2005

    End Date

    March 1 2011

    Last Update

    April 23 2013

    Active Locations (8)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (8 locations)

    1

    Cedars-Sinai Outpatient Cancer Center

    Los Angeles, California, United States

    2

    UCSF

    San Francisco, California, United States, 94143

    3

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

    Boston, Massachusetts, United States, 02115

    4

    Roswell Park Cancer Institute

    Buffalo, New York, United States, 14263-0001