MMY2012

COLUMBA study

A Phase 3 Randomized, Multicenter Study of Subcutaneous vs. Intravenous Administration of Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma

Disease:

Multiple Myeloma (MM)

Summary:

Multiple myeloma (MM) is a cancer of plasma cells which produce antibodies, an important immune system product. The abnormal antibodies are produced in excess amount, and can accumulate in the kidney (causing kidney failure), in bones (causing fractures and leeching of calcium into the blood) and bone marrow (causing low blood counts).

Though there are treatments for multiple myeloma, it is not curable and the disease will come back.

This trial is for patients who have been treated for myeloma before, and the disease has continued to grow or has returned. Patients will receive daratumumab, an immune therapy which targets the plasma cells. Patients will have a 50:50 chances of receiving daratumumab in subcutaneous injection (under the skin) form or intravenous (through a drip) form.

The aim of the trial is to see whether daratumumab in subcutaneous and intravenous form is effective in treating myeloma.

Eligibility:

Include, but not limited to, the following:

Include, but not limited to, the following:
- A diagnosis of multiple myeloma that has continued to grow (refractory) or returned (relapsed) after at least three lines of treatment
- No other active cancer (other than some cancers cured with minor operations like skin cancer)
- No previous use of daratumumab or similar immunotherapy

Contact person:

Louise Hay

Email louise.hay@health.wa.gov.au

Phone 6457 7600

Principal Investigator:

Dr Bradley Augustson

08 6457 7600

Sponsor:

Janssen Research & Development

Phase:

III

Protocol Number:

54767414MMY3012

Trial Registration Number:

NCT03277105

Clinical Trials.gov

ANZ Clinical Trial Registry