Know Cancer

or
forgot password

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
Not Enrolling
Both
Multiple Myeloma

Thank you

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 UniversityPortland, Oregon  
Dana Farber Cancer Institute StudyCoordinator:CHCD122A2102Boston, Massachusetts  02115
St. Vincent's Comprehensive Cancer Center Dept. of St. Vincent's CancerNew York, New York  10011
University of Pennsylvania--Abramson Cancer Center StudyCoordinator:CHCD122A2102Philadelphia, Pennsylvania  19104
Fred Hutchinson Cancer Research Center Dept. of FHCRCSeattle, Washington  98109