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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BB-10901
Sponsored by
ImmunoGen, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Outpatient Cancer Center
  • UCSF
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  • Roswell Park Cancer Institute
  • St. Vincent's Comprehensive Cancer Center - Manhattan
  • Gascon 450 - (C1181ACH)
  • Juan Domingo Peron 1500 - (B1629AHJ) Pilar
  • Av. Naciones Unidas 346. (X5016KEH)-Barrio Parque Velez Sarfield

Outcomes

Primary Outcome Measures

Dose-limiting toxicity
Maximum tolerated dose

Secondary Outcome Measures

Qualitative and quantitative toxicities
Pharmacokinetics
Anti-tumor activity including overall response rate, time to progression and survival

Full Information

First Posted
June 28, 2006
Last Updated
April 22, 2013
Sponsor
ImmunoGen, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00346255
Brief Title
BB-10901 in Treating Patients With Relapsed and/or Refractory Multiple Myeloma
Acronym
IMGN901
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ImmunoGen, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
BB-10901
Other Intervention Name(s)
IMGN901
Intervention Description
dose escalation study, doses will vary per cohort. patients will receive an IV infusion weekly for two weeks every three weeks.
Primary Outcome Measure Information:
Title
Dose-limiting toxicity
Time Frame
through cycle 1
Title
Maximum tolerated dose
Time Frame
for the duration of the study
Secondary Outcome Measure Information:
Title
Qualitative and quantitative toxicities
Time Frame
for the duration of the study
Title
Pharmacokinetics
Time Frame
for the duration of the study
Title
Anti-tumor activity including overall response rate, time to progression and survival
Time Frame
for the duration of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asher Alban Akmal Chanan-Khan,, M.D.
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Outpatient Cancer Center
City
Los Angeles
State/Province
California
Country
United States
Facility Name
UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
St. Vincent's Comprehensive Cancer Center - Manhattan
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Gascon 450 - (C1181ACH)
City
Buenos Aires
State/Province
Capital Federal
Country
Argentina
Facility Name
Juan Domingo Peron 1500 - (B1629AHJ) Pilar
City
Buenos Aires
Country
Argentina
Facility Name
Av. Naciones Unidas 346. (X5016KEH)-Barrio Parque Velez Sarfield
City
Córdoba
Country
Argentina

12. IPD Sharing Statement

Learn more about this trial

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

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