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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ImmunoGen, Inc.
ClinicalTrials.gov Identifier:
NCT00346255
First received: June 28, 2006
Last updated: April 22, 2013
Last verified: April 2013
  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
Drug: BB-10901
Phase 1

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

Resource links provided by NLM:


Further study details as provided by ImmunoGen, Inc.:

Primary Outcome Measures:
  • Dose-limiting toxicity [ Time Frame: through cycle 1 ] [ 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 including overall response rate, time to progression and survival [ Time Frame: for the duration of the study ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: April 2005
Study Completion Date: March 2011
Primary Completion Date: March 2011 (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.
    Other Name: IMGN901
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.

  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
    • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346255

Locations
United States, California
Cedars-Sinai Outpatient Cancer Center
Los Angeles, California, United States
UCSF
San Francisco, California, United States, 94143
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
St. Vincent's Comprehensive Cancer Center - Manhattan
New York, New York, United States, 10011
Argentina
Gascon 450 - (C1181ACH)
Buenos Aires, Capital Federal, Argentina
Juan Domingo Peron 1500 - (B1629AHJ) Pilar
Buenos Aires, Argentina
Av. Naciones Unidas 346. (X5016KEH)-Barrio Parque Velez Sarfield
Córdoba, Argentina
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.
ClinicalTrials.gov Identifier: NCT00346255     History of Changes
Obsolete Identifiers: NCT00625508
Other Study ID Numbers: CDR0000491241, IMMUNO-003, DFCI-05031
Study First Received: June 28, 2006
Last Updated: April 22, 2013
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

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

ClinicalTrials.gov processed this record on October 01, 2014