DREAMM6

DREAMM6

To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Subjects With Relapsed/Refractory Multiple Myeloma (RRMM)

Disease:

Multiple Myeloma

Summary:

Plasma cells are part of the immune system and are normally found in small numbers in the bone marrow. In a healthy immune system, they are responsible for producing antibodies to fight infection. Multiple myeloma, also known as myeloma, is a cancer of plasma cells. This results in excess production of abnormal antibodies, or of their component parts known as light chains, which can accumulate in the kidney, bones and bone marrow. This can result in kidney failure, fractures, high calcium levels and low blood counts which may in turn lead to fatigue, shortness of breath, bleeding and infections.
There are now many different treatment options for myeloma, but it remains incurable. This means that even though myeloma can often be treated very effectively, it will come back at some stage.
One class of therapy in development for myeloma is antibody-drug-conjugates. These consist of an antibody which binds to a specific target on cancer cells, joined to another compound which facilitates the cancer cell to internalise the molecule, and subsequently release a ‘killing’ molecule inside the cancer cell, leading to cancer cell death.
B cell maturation antigen (BCMA) is one protein that is expressed at high levels on myeloma cells. GSK2857916, the antibody-drug conjugate being investigated in this trial, targets and binds to BCMA, is internalised, and leads to myeloma cell death.
In this trial, GSK2857916 is given in combination with established myeloma treatment, - dexamethasone plus either lenalidomide or bortezemib. The treatment received alongside the trial drug is decided for each individual patient by the trial doctors.
This trial is for people with myeloma who have previously received treatment for myeloma, and the myeloma has either not responded to treatment, or has responded well but has now come back.

Eligibility:

Include, but not limited to, the following:

Including but not limited to the following,
- A diagnosis of multiple myeloma.
- Received at least one previous treatment for myeloma, and the myeloma has progressed either during or after this treatment (including previous autologous stem cell transplant)
- Myeloma protein levels in the blood >5g/L or myeloma light chain >100mg/L.
- No serious medical conditions
- Patients with previous or concurrent active cancer will be allowed, if the cancer is not related to the current myeloma.
- No history of current corneal eye disease, except for a very mild form known as mild punctate keratopathy.

Contact person:

Lewis Edwards (Clinical trials Coordinator, Linear Clinical Research)
Email ledwards@linear.org.au
Phone


Email
Phone

Principal Investigator:

Dr Bradley Augustson

Sponsor:

Glaxosmithkleine

Phase:

I/II

Protocol Number:

LO180303

Trial Registration Number:

NCT03544281

Clinical Trials.gov

ANZ Clinical Trial Registry