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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
HCD122
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring dose-finding, monoclonal antibody, Multiple Myeloma

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dana Farber Cancer Institute StudyCoordinator:CHCD122A2102
  • St. Vincent's Comprehensive Cancer Center Dept. of St. Vincent's Cancer
  • Oregon Health Sciences University
  • University of Pennsylvania--Abramson Cancer Center StudyCoordinator:CHCD122A2102
  • Fred Hutchinson Cancer Research Center Dept. of FHCRC
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HCD122

Arm Description

Outcomes

Primary Outcome Measures

Safety, pharmacokinetics and pharmacodynamics at multiple doses

Secondary Outcome Measures

Clinical response after various doses

Full Information

First Posted
September 30, 2005
Last Updated
October 9, 2018
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00231166
Brief Title
Safety, Efficacy, Dose-finding Study of a Monoclonal Antibody in Patients With Multiple Myeloma
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
dose-finding, monoclonal antibody, Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HCD122
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
HCD122
Primary Outcome Measure Information:
Title
Safety, pharmacokinetics and pharmacodynamics at multiple doses
Time Frame
At the completion of each dose escalation cohort
Secondary Outcome Measure Information:
Title
Clinical response after various doses
Time Frame
Once a month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmeceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Dana Farber Cancer Institute StudyCoordinator:CHCD122A2102
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
St. Vincent's Comprehensive Cancer Center Dept. of St. Vincent's Cancer
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Pennsylvania--Abramson Cancer Center StudyCoordinator:CHCD122A2102
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center Dept. of FHCRC
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Novartis Investigative Site
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Novartis Investigative Site
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

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

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