Safety, Efficacy, Dose-finding Study of a Monoclonal Antibody in Patients With Multiple Myeloma
- Registration Number
- NCT00231166
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HCD122 HCD122 -
- Primary Outcome Measures
Name Time Method Safety, pharmacokinetics and pharmacodynamics at multiple doses At the completion of each dose escalation cohort
- Secondary Outcome Measures
Name Time Method Clinical response after various doses Once a month
Trial Locations
- Locations (6)
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
Fred Hutchinson Cancer Research Center Dept. of FHCRC
🇺🇸Seattle, Washington, United States
Novartis Investigative Site
🇦🇺Prahran, Victoria, Australia
Dana Farber Cancer Institute StudyCoordinator:CHCD122A2102
🇺🇸Boston, Massachusetts, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States