Safety, Efficacy, Dose-finding Study of a Monoclonal Antibody in Patients With Multiple Myeloma
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00231166
First received: September 30, 2005
Last updated: November 26, 2012
Last verified: November 2012
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Purpose
The purpose of this study is to determine the highest tolerated dose, safety and activity of HCD122 in patients with Multiple Myeloma who are relapsed after receiving prior treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: HCD122 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I, Dose-finding Trial of HCD122, an Anti-CD40 Monoclonal Antibody, in Patients With Multiple Myeloma That is Relapsed or Has Not Responded to Prior Therapy (CHIR1212-C12101) |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Safety, pharmacokinetics and pharmacodynamics at multiple doses [ Time Frame: At the completion of each dose escalation cohort ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Clinical response after various doses [ Time Frame: Once a month ] [ Designated as safety issue: No ]
| Enrollment: | 33 |
| Study Start Date: | September 2005 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: HCD122 | Drug: HCD122 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Clinical Diagnosis of MM requiring treatment
- Refractory or Relapsed Disease
- At least one prior treatment regimen
- Male or Female
- >18 years of age
Exclusion Criteria:
- Prior Allogeneic bone marrow transplant (prior autologous transplant allowed)
- Intracranial disease or epidural disease
- Clinically significant cardiac dysfunction or other significant organ dysfunction
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00231166
Locations
| United States, Massachusetts | |
| Dana Farber Cancer Institute StudyCoordinator:CHCD122A2102 | |
| Boston, Massachusetts, United States, 02115 | |
| United States, New York | |
| St. Vincent's Comprehensive Cancer Center Dept. of St. Vincent's Cancer | |
| New York, New York, United States, 10011 | |
| United States, Oregon | |
| Oregon Health Sciences University | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| University of Pennsylvania--Abramson Cancer Center StudyCoordinator:CHCD122A2102 | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center Dept. of FHCRC | |
| Seattle, Washington, United States, 98109 | |
| Australia, Queensland | |
| Novartis Investigative Site | |
| Herston, Queensland, Australia, 4029 | |
| Australia, Victoria | |
| Novartis Investigative Site | |
| Prahran, Victoria, Australia, 3181 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmeceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00231166 History of Changes |
| Obsolete Identifiers: | NCT00304109 |
| Other Study ID Numbers: | CHCD122A2102 |
| Study First Received: | September 30, 2005 |
| Last Updated: | November 26, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novartis:
|
dose-finding monoclonal antibody 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 Antibodies Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013