CompletedPhase IIIInterventional

A study comparing talquetamab in combination with daratumumab or in combination with daratumumab and pomalidomide versus daratumumab in combination with pomalidomide and dexamethasone in participants with multiple myeloma that returns after treatment or is resistant to treatment

Multiple myeloma is a type of blood cancer that affects white blood cells in the bone marrow. Although treatments can work well at first, the cancer often comes back or becomes resistant to treatment over time. This trial is testing a targeted medicine called talquetamab. Talquetamab works by helping the body's own immune system find and attack cancer cells. In this trial, researchers are comparing combinations that include talquetamab against a common standard treatment (daratumumab, pomalidomide, and dexamethasone). The study aims to discover which combination keeps myeloma under control for longer. Adults who have already had at least one previous treatment for myeloma may be eligible. Taking part involves having injections under the skin, taking tablets, and visiting the clinic for regular health and blood monitoring.

At a glance

Status

Completed

Phase

Phase III

Sponsor

Janssen (Netherlands)

Enrolment target

810

Start

13 Oct 2022

Estimated completion

29 Mar 2024

Relapsed or refractory multiple myeloma

What is this study about?

Multiple myeloma is a cancer that starts in plasma cells, which are white blood cells found inside your bone marrow. In healthy bodies, plasma cells help fight off infections. In multiple myeloma, abnormal cells build up, crowd out healthy blood cells, and cause problems like bone pain, tiredness, and frequent infections. While treatments can put the disease into remission, it is very common for the cancer to return (relapse) or stop responding to standard medicines (refractory).

To tackle this, scientists are developing immunotherapies—treatments that empower your own immune system to destroy cancer cells. Talquetamab is a specialised antibody that acts like a bridge. It grabs onto an immune cell (a T cell) with one end and attaches to a myeloma cell with the other. This brings the immune cell close enough to attack and kill the cancer cell.

This Phase III clinical trial compares combinations using talquetamab against an established three-drug treatment. By comparing these groups directly, doctors hope to see if talquetamab can safely keep myeloma from getting worse for longer, which could improve future options for people living with this illness.

Key takeaways

Phase III study comparing new talquetamab combinations against an existing standard treatment.
Aimed at adults whose multiple myeloma has returned or stopped responding to past therapy.
Talquetamab helps your own immune T cells target and destroy myeloma cells.
Treatment involves injections under the skin, oral tablets, and regular hospital monitoring.
Participation is voluntary, and you can leave at any time without losing standard medical care.

Who may be eligible?

This study is open to adults aged 18 and over who have multiple myeloma that has returned or stopped responding to earlier treatments. To take part, you must have already received at least one prior course of myeloma therapy that included certain standard drugs, such as lenalidomide and a proteasome inhibitor.

Your doctor must be able to detect the cancer through routine blood or urine tests, and there must be evidence that the cancer has started to grow or change since your last treatment. You will also need to be well enough to carry out daily activities and look after yourself.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am 18 years of age or older.
I have a confirmed diagnosis of multiple myeloma.
My cancer has returned or stopped responding after at least one previous treatment.
I have previously received standard drugs such as lenalidomide.
I am well enough to manage daily personal care and walk around.

Answer every question to see your result.

What does participation involve?

Taking part begins with a screening period lasting up to 28 days to check if the trial is right for you. If you join, you will be placed into one of three treatment groups. Depending on your group, you will receive talquetamab combined with daratumumab, with or without pomalidomide, or you will receive the standard combination of daratumumab, pomalidomide, and dexamethasone.

Treatments are given in 28-day cycles. Talquetamab and daratumumab are given as small injections under the skin, pomalidomide is taken as capsules by mouth, and dexamethasone is taken as tablets or an injection into a vein.

You will attend regular hospital appointments for check-ups, physical exams, and blood tests to monitor your health and see how the cancer responds. You can remain on study treatment as long as it is helping you and the side effects are manageable, with follow-up checks continuing over several years. Travel costs for study visits are usually reimbursed.

Potential risks and benefits

A potential benefit is that talquetamab combinations may help control your cancer for longer, though this cannot be promised. You will also receive very close, regular health monitoring from a specialist cancer team. However, all cancer treatments carry risks of side effects. Common risks include immune reactions like fever or chills (cytokine release syndrome), low blood counts, increased risk of infections, skin and nail changes, mouth soreness, and soreness where injections are given. Temporary nerve or thinking problems can also occur. Your care team will monitor you closely to manage any issues quickly, and you have the right to leave the study at any time without it affecting your standard NHS care.

Locations (1)

Derriford Hospital
Approximate
Plymouth, England

Common questions

Will I definitely receive the new drug talquetamab?

Not necessarily. A computer randomly assigns participants to one of three groups. Two groups receive talquetamab combinations, while one group receives standard approved treatments without talquetamab.

Do I have to pay for the trial medicines?

No. The study sponsor pays for the trial drugs and any extra tests required for the study. You may also receive reimbursement for reasonable travel and parking expenses.

How often will I need to visit the hospital?

Visits are more frequent during the first few weeks for treatment and safety checks. Over time, visits usually settle into regular appointments based on the 28-day treatment cycles.

What happens if my cancer gets worse during the trial?

Your study doctor will monitor your tests closely. If tests show your cancer is growing, the trial treatment will stop, and your medical team will discuss other treatment options with you.

Can I leave the study if I change my mind?

Yes. Taking part is completely voluntary. You are free to withdraw at any point, for any reason, and your regular doctors will continue to care for you.

How to find out more

Simon Waddell

JanssenUKRegistryQueries@its.jnj.com +44 7393 468879 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.