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)
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma
Both
Multiple Myeloma
Trial Information
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)
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety, pharmacokinetics and pharmacodynamics at multiple doses
Outcome Time Frame:
At the completion of each dose escalation cohort
Safety Issue:
Yes
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CHCD122A2102
NCT ID:
NCT00231166
Start Date:
September 2005
Completion Date:
May 2009
Related Keywords:
- Multiple Myeloma
- dose-finding
- monoclonal antibody
- Multiple Myeloma
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| Oregon Health Sciences University | Portland, Oregon |
| Dana Farber Cancer Institute StudyCoordinator:CHCD122A2102 | Boston, Massachusetts 02115 |
| St. Vincent's Comprehensive Cancer Center Dept. of St. Vincent's Cancer | New York, New York 10011 |
| University of Pennsylvania--Abramson Cancer Center StudyCoordinator:CHCD122A2102 | Philadelphia, Pennsylvania 19104 |
| Fred Hutchinson Cancer Research Center Dept. of FHCRC | Seattle, Washington 98109 |
