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

This study is currently recruiting participants.

Verified by Novartis, January 2008

First Received: September 30, 2005 Last Updated: January 2, 2008 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00231166

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 I

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

Further study details as provided by Novartis:

Primary Outcome Measures:

Safety, pharmacokinetics and pharmacodynamics at multiple doses

Secondary Outcome Measures:

Clinical response after various doses

Estimated Enrollment:

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

Contacts

Contact: Novartis

862 778 8300

Locations

United States, Massachusetts
Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
United States, New York
St. Vincent's Comprehensive Cancer Center	Recruiting
New York, New York, United States, 10011
United States, Pennsylvania
University of Pennsylvania Abramson Cancer Center	Recruiting
Philadelphia, Pennsylvania, United States, 19014
United States, Washington
Fred Hutchinson Cancer Research Center	Recruiting
Seattle, Washington, United States, 98109
Australia
	Recruiting
Brisbane, Australia
	Recruiting
Melbourne, Australia
	Recruiting
Adelaide, Australia
	Recruiting
Canberra, Australia

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

No publications provided

Study ID Numbers:	CHCD122A2102
Study First Received:	September 30, 2005
Last Updated:	January 2, 2008
ClinicalTrials.gov Identifier:	NCT00231166 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Immunoproliferative Disorders
Immunologic Factors
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Hemostatic Disorders

Multiple Myeloma
Antibodies, Monoclonal
Signs and Symptoms
Antibodies
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoglobulins
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immunologic Factors
Immune System Diseases
Blood Protein Disorders
Hematologic Diseases
Physiological Effects of Drugs
Vascular Diseases
Paraproteinemias

Hemostatic Disorders
Pharmacologic Actions
Multiple Myeloma
Antibodies, Monoclonal
Neoplasms
Hemorrhagic Disorders
Cardiovascular Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on May 07, 2009