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BB-10901 in Treating Patients With Relapsed and/or Refractory Multiple Myeloma (IMGN901)
This study is currently recruiting participants.
Verified by ImmunoGen, Inc., April 2009
First Received: June 28, 2006   Last Updated: April 1, 2009   History of Changes
Sponsored by: ImmunoGen, Inc.
Information provided by: ImmunoGen, Inc.
ClinicalTrials.gov Identifier: NCT00346255
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Drug: BB-10901
Phase I

Genetics Home Reference related topics: aceruloplasminemia hemophilia myotonic dystrophy
MedlinePlus related topics: Cancer Multiple Myeloma
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: 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

Further study details as provided by ImmunoGen, Inc.:

Primary Outcome Measures:
  • Dose-limiting toxicity [ Time Frame: for the duration of the study ] [ Designated as safety issue: Yes ]
  • Maximum tolerated dose [ Time Frame: for the duration of the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Qualitative and quantitative toxicities [ Time Frame: for the duration of the study ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: for the duration of the study ] [ Designated as safety issue: No ]
  • Anti-tumor activity [ Time Frame: for the duration of the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2005
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: BB-10901
    dose escalation study, doses will vary per cohort. patients will receive an IV infusion weekly for two weeks every three weeks.
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

  • Determine the qualitative and quantitative toxicities of this drug in these patients.
  • Evaluate the pharmacokinetics of this drug in these patients.
  • Determine the recommended phase II dose of this drug.
  • Evaluate the anti-tumor activity of this drug in these patients.

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 15 patients are treated at the MTD.

After completion of study treatment, patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed multiple myeloma
  • Relapsed or relapsed/refractory disease

    • Failed ≥ 1 prior therapy for multiple myeloma
  • CD56-positive disease by immunohistochemistry or flow cytometry, as defined by 1 of the following:

    • Staining intensity is ≥ 1 (weak) and the uniformity of staining is ≥ focal (i.e., present on < 25% of myeloma cells) in the bone marrow aspirate or core bone marrow biopsy (using immunohistochemistry)
    • At least 5% CD56-positive myeloma cells on flow cytometry of the marrow aspirate using dual staining for CD138 and CD56 (using 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
  • 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00346255

Locations
United States, California
UCSF Recruiting
San Francisco, California, United States, 94143
Contact: Beth Davis     415-502-3176        
Principal Investigator: Jeffrey Wolf, MD            
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Withdrawn
Boston, Massachusetts, United States, 02115
United States, New Jersey
Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Mecide Gharibo, MD     732-235-8776     gharibmm@umdnj.edu    
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263-0001
Contact: Asher A. Chanan-Khan, MD     716-845-3221     Asher.Chanan-Khan@RoswellPark.org    
St. Vincent's Comprehensive Cancer Center - Manhattan Withdrawn
New York, New York, United States, 10011
Sponsors and Collaborators
ImmunoGen, Inc.
Investigators
Principal Investigator: Asher Alban Akmal Chanan-Khan,, M.D. Roswell Park Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: ImmunoGen, Inc. ( Clinical Operations )
Study ID Numbers: CDR0000491241, IMMUNO-003, DFCI-05031
Study First Received: June 28, 2006
Last Updated: April 1, 2009
ClinicalTrials.gov Identifier: NCT00346255     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by ImmunoGen, Inc.:
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
refractory plasma cell neoplasm

Study placed in the following topic categories:
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Myotonic Dystrophy
Lymphoproliferative Disorders
Myotonic Dystrophy 1
Myotonia Atrophica
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Blood Protein Disorders
Hematologic Diseases
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Neoplasms
Hemorrhagic Disorders
Cardiovascular Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on May 07, 2009