Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Immunomedics, Inc. |
---|---|
Information provided by: | Immunomedics, Inc. |
ClinicalTrials.gov Identifier: | NCT00421525 |
This is a Phase I/II, open-label, multi-center study conducted in patients with recurrent or refractory multiple myeloma who have failed at least two prior standard systemic treatments.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma Myeloma, Plasma-Cell Plasmacytoma |
Biological: milatuzumab |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Study of Immunotherapy With hLL1 Administered Twice Weekly for 4 Consecutive Weeks in Patients With Multiple Myeloma |
Estimated Enrollment: | 66 |
Study Start Date: | January 2007 |
Arms | Assigned Interventions |
---|---|
Multiple Doses: Active Comparator
Multiple Dose levels
|
Biological: milatuzumab
twice weekly dosing for 4 weeks, total of 8 doses
|
All patients receive hLL1 administered intravenously twice weekly for 4 consecutive weeks. Cohorts of 3-6 patients will receive escalating doses of hLL1 in order to determine the maximum tolerated dose (MTD) for this administration schedule. Up to approximately 30 additional patients will be entered at one or more dose levels at or below the MTD in order to determine the optimal dose for subsequent studies.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dennis Simpson, RN | 973-605-8200 | dsimpson@immunomedics.com |
Contact: Heather Horne | 973-727-7589 | hhorne@immunomedics.com |
United States, Georgia | |
Winship Cancer Institute, Emory University | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Dennis Simpson, RN 973-605-8200 | |
Principal Investigator: Jonathan Kaufman, MD | |
United States, Indiana | |
Center for Cancer Care | Recruiting |
Goshen, Indiana, United States, 46526 | |
Contact: Susan Garl, RN 574-535-2974 | |
Principal Investigator: Daniel Bruetman, MD | |
United States, New Jersey | |
Hackensack University Medical Center | Recruiting |
Hackensack, New Jersey, United States, 07601 | |
Contact: Dennis Simpson 973-605-8200 | |
Principal Investigator: David Siegel, MD | |
United States, New York | |
New York Presbyterian Hospital/Cornell Medical Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: Jessica Coyne 212-746-1540 | |
Principal Investigator: Ruben Niesvizky, MD | |
Roswell Park Cancer Institute | Recruiting |
Buffalo, New York, United States, 14263 | |
Contact: Dennis Simpson 973-605-8200 | |
Principal Investigator: Asher Chanan-Khan, MD | |
United States, Pennsylvania | |
Hospital University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Dennis Simpson, RN 973-605-8200 | |
Principal Investigator: Edward Stadtmauer, MD |
Study Chair: | William Wegener, MD, PhD | Immunomedics, Inc. |
Responsible Party: | Immunomedics, Inc. ( William Wegener ) |
Study ID Numbers: | PROTOCOL: IMMU-115-01 |
Study First Received: | January 11, 2007 |
Last Updated: | August 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00421525 History of Changes |
Health Authority: | United States: Food and Drug Administration |
multiple myeloma Myeloma, Plasma-Cell PLASMACYTOMA |
Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias Hemostatic Disorders |
Multiple Myeloma Hemorrhagic Disorders Plasmacytoma Plasmacytoma Anaplastic Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Blood Protein Disorders Hematologic Diseases Vascular Diseases Paraproteinemias Hemostatic Disorders |
Multiple Myeloma Neoplasms Hemorrhagic Disorders Plasmacytoma Cardiovascular Diseases Lymphoproliferative Disorders Neoplasms, Plasma Cell |