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

NCT ID: NCT00231166

Last Updated: 2018-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2009-05-31

Brief Summary

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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

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HCD122

Group Type EXPERIMENTAL

HCD122

Intervention Type DRUG

Interventions

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HCD122

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmeceuticals

Locations

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Dana Farber Cancer Institute StudyCoordinator:CHCD122A2102

Boston, Massachusetts, United States

Site Status

St. Vincent's Comprehensive Cancer Center Dept. of St. Vincent's Cancer

New York, New York, United States

Site Status

Oregon Health Sciences University

Portland, Oregon, United States

Site Status

University of Pennsylvania--Abramson Cancer Center StudyCoordinator:CHCD122A2102

Philadelphia, Pennsylvania, United States

Site Status

Fred Hutchinson Cancer Research Center Dept. of FHCRC

Seattle, Washington, United States

Site Status

Novartis Investigative Site

Herston, Queensland, Australia

Site Status

Novartis Investigative Site

Prahran, Victoria, Australia

Site Status

Countries

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United States Australia

Other Identifiers

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CHCD122A2102

Identifier Type: -

Identifier Source: org_study_id

NCT00304109

Identifier Type: -

Identifier Source: nct_alias

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