Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
ImmunoGen, Inc. |
---|---|
Information provided by: | ImmunoGen, Inc. |
ClinicalTrials.gov Identifier: | NCT00346255 |
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 |
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 |
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) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Relapsed or relapsed/refractory disease
CD56-positive disease by immunohistochemistry or flow cytometry, as defined by 1 of the following:
PATIENT CHARACTERISTICS:
No significant cardiac disease, including any of the following:
PRIOR CONCURRENT THERAPY:
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)
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 |
Principal Investigator: | Asher Alban Akmal Chanan-Khan,, M.D. | Roswell Park Cancer Institute |
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 |
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma refractory plasma cell neoplasm |
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 |
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 |