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

Novartis

Status and phase: Completed; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: HCD122

Study type: Interventional

Funder types: Industry

Identifiers

NCT00231166

CHCD122A2102

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

HCD122

Experimental group

Treatment:

Drug: HCD122