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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00231166
Other study ID # CHCD122A2102
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 2005
Est. completion date May 2009

Study information

Verified date October 2018
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Other known NCT identifiers
  • NCT00304109

Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
HCD122


Locations

Country Name City State
Australia Novartis Investigative Site Herston Queensland
Australia Novartis Investigative Site Prahran Victoria
United States Dana Farber Cancer Institute StudyCoordinator:CHCD122A2102 Boston Massachusetts
United States St. Vincent's Comprehensive Cancer Center Dept. of St. Vincent's Cancer New York New York
United States University of Pennsylvania--Abramson Cancer Center StudyCoordinator:CHCD122A2102 Philadelphia Pennsylvania
United States Oregon Health Sciences University Portland Oregon
United States Fred Hutchinson Cancer Research Center Dept. of FHCRC Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety, pharmacokinetics and pharmacodynamics at multiple doses At the completion of each dose escalation cohort
Secondary Clinical response after various doses Once a month
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