An Open-label Phase I Study of the Safety and Efficacy of MDX-1097 in the Treatment of Previously Treated Kappa Light Chain Restricted Multiple Myeloma Patients with Stable Measurable Disease

An Open-label Phase I Study of the Safety and Efficacy of MDX-1097, an human IgG1k chimeric monoclonal antibody, in the Treatment of Previously Treated Kappa Light Chain Restricted Multiple Myeloma Patients with Stable Measurable Disease to determine the Safety, Tolerability and Maximum Tolerated Dose

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000336381

Enrollment

Registered

2008-07-16

Start date

2008-06-04

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This Phase I study is a single-center, open-label, between-patient, single ascending dose study intended to determine the safety, tolerability and maximum tolerated dose (MTD) of MDX-1097.

Interventions

This is a Phase I study of MDX-1097 an IgG1k chimeric monoclonal antibody. Up to 30 previously treated multiple myeloma patients with stable measurable disease will be enrolled in the study. Five dose levels are planned: 0.3 mg/kg, 1.0 mg/kg, 3.0 mg/kg, 10 mg/kg and 30 mg/kg per dose will be administered as a single intravenous infusion. Patients will be assigned to a dose level in the order of study entry.

Study design

Allocation

Non-randomised trial

Intervention model

Other

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Diagnosis of kappa light chain restricted multiple myeloma with stable measurable disease. Serum paraprotein of > 5 g/L, 24 hour urinary light chain excretion of > 200 mg, or demonstration of excess serum free kappa light chains and an abnormal kappa:lambda light chain ratio. Patients on maintenance therapy for multiple myeloma

Exclusion criteria

Non-measurable disease by serological measurement, serum free kappa light chains > 250 mg/L, active infections, pregnant or lactating women, any other active malignancy, patients on other investigational agents.

Outcome results