|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Immunomedics, Inc. |
|---|---|
| Information provided by (Responsible Party): | Immunomedics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01101594 |
Purpose
This study is a Ph I trial to test the safety of the study drug, hLL1-DOX at different dose levels in patients with recurrent multiple myeloma. HLL1 is also known as milatuzumab and is attached to doxorubicin in this clinical trial.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: hLL1-DOX (the doxorubicin conjugate of milatuzumab) |
Phase I Phase II |
| 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/II Study of hLL1-DOX (Milatuzumab-Doxorubicin Antibody-Drug Conjugate) in Patients With Multiple Myeloma |
| Estimated Enrollment: | 42 |
| Study Start Date: | July 2010 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: hLL1-DOX
4 Different dose levels of hLL1-DOX will be studied in groups of 3-6 patients. Once an optimal dose has been found, up to additional 30 patients will be studied at that dose level.
|
Drug: hLL1-DOX (the doxorubicin conjugate of milatuzumab)
hLL1-DOX will be administered intravenously (through a vein) on days 1, 4, 8 & 11 every 21 days for up to 8 treatment cycles. 4 different dose levels of hLL1-DOX will be studied for safety and tolerability.
Other Names:
|
In this clinical research trial, hLL1-DOX will be administered on days 1, 4, 8 and 11. This treatment cycle will be repeated every 3 weeks as long as patients continue to tolerate it, for a maximum of 8 treatment cycles (approximately 6 months).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Heather Horne | 9736058200 | |
| Contact: Fran Bozza | 9736058200 | fbozza@immunnomedics.com |
| United States, Florida | |
| MD Anderson Orlando | Recruiting |
| Orlando, Florida, United States, 32806 | |
| United States, Georgia | |
| Georgia Cancer Specialists | Recruiting |
| Atlanta, Georgia, United States, 30068 | |
| United States, New Jersey | |
| Hackensack University Medical Center | Recruiting |
| Hackensack, New Jersey, United States, 07601 | |
| United States, Pennsylvania | |
| University Hospital of Pennsylvania | Recruiting |
| Philadelphi, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| MD Anderson Center | Recruiting |
| Houston, Texas, United States, 77030 | |
More Information
| Responsible Party: | Immunomedics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01101594 History of Changes |
| Other Study ID Numbers: | IM-T-hLL1-DOX-01 |
| Study First Received: | March 11, 2010 |
| Last Updated: | February 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Treatment Multiple Myeloma Relapsed, refractory multiple myeloma |
|
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 Doxorubicin Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |