Multiple Myeloma Clinical Trial
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)
Verified date | October 2018 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 33 |
Est. completion date | May 2009 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Australia | Novartis Investigative Site | Herston | Queensland |
Australia | Novartis Investigative Site | Prahran | Victoria |
United States | Dana Farber Cancer Institute StudyCoordinator:CHCD122A2102 | Boston | Massachusetts |
United States | St. Vincent's Comprehensive Cancer Center Dept. of St. Vincent's Cancer | New York | New York |
United States | University of Pennsylvania--Abramson Cancer Center StudyCoordinator:CHCD122A2102 | Philadelphia | Pennsylvania |
United States | Oregon Health Sciences University | Portland | Oregon |
United States | Fred Hutchinson Cancer Research Center Dept. of FHCRC | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States, Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety, pharmacokinetics and pharmacodynamics at multiple doses | At the completion of each dose escalation cohort | ||
Secondary | Clinical response after various doses | Once a month |
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