Safety, Efficacy, Dose-finding Study of a Monoclonal Antibody in Patients With Multiple Myeloma

This study has been completed.
Sponsor:
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
  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 April 15, 2014