EFC12522

IMROZ study

A Phase 3 randomized, open-label, multicenter study assessing the clinical benefit of isatuximab (SAR650984) in combination with bortezomib (Velcade®), lenalidomide (Revlimid®) and dexamethasone versus bortezomib, lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma not eligible for transplant

Disease:

Multiple Myeloma (MM)

Summary:

Multiple myeloma (MM) is a cancer of plasma cells which produce antibodies, an 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 newly diagnosed multiple myeloma and have not received treatment before. Patients will receive, as a minimum, bortezomib, a subcutaneous (under the skin) chemotherapy which works by stopping plasma cells from multiplying, lenalidomide, a tablet chemotherapy which encourages plasma cells to die and dexamethasone, a steroid. In addition, patients on this trial will have a 3:2 chance of receiving isatuximab, a plasma cell targeting antibody given through an intravenous drip.

The aim of the trial is to see whether the addition of isatuximab is more effective compared with bortezomib, lenalidomide and dexamethasone alone.

Eligibility:

Include, but not limited to, the following:

- A diagnosis of multiple myeloma with no previous treatment
- Patients not suitable for an autologous stem cell transplant (high dose chemotherapy) due to age or other medical illnesses
- No other active cancers (other than some cancers cured with minor operations like skin cancer)

Contact person:

Louise Hay

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

Phone 6457 7600

Principal Investigator:

Dr Bradley Augustson

08 6457 7600

Sponsor:

Sanofi-Aventis Australia

Phase:

III

Protocol Number:

EFC12522

Trial Registration Number:

NCT03319667

Clinical Trials.gov

ANZ Clinical Trial Registry