Not yet recruitingPhase IIIInterventional

A study of ramantamig plus daratumumab versus investigator’s choice in participants with newly diagnosed multiple myeloma

Multiple myeloma is a type of blood cancer that affects plasma cells in bone marrow. While existing treatments can help manage it, the cancer often returns, meaning new options are urgently needed. This Phase 3 trial compares a new medicine called ramantamig, given alongside an established treatment called daratumumab, against standard treatment options. Ramantamig works by helping your body's own immune system recognise and attack cancer cells. Doctors are looking for adults aged 18 and over who have been newly diagnosed with multiple myeloma and are not planning to have a stem cell transplant. Half the participants will receive the new drug combination, while the other half will receive current standard care. Taking part involves regular hospital visits, health checks, and blood tests over several years to carefully monitor your health and response to treatment.

At a glance

Status

Not yet recruiting

Phase

Phase III

Sponsor

Janssen-Cilag International N.V.

Enrolment target

1,000

Start

28 Oct 2026

Estimated completion

15 Aug 2028

Newly diagnosed 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 people, these cells make antibodies to fight off infections. In multiple myeloma, abnormal plasma cells grow out of control. Although modern therapies can keep the disease under control for long periods, it often comes back. Because of this, doctors are constantly searching for gentler, more effective treatments.

This clinical trial looks at an experimental drug called ramantamig. Ramantamig is a specialised type of immunotherapy. It acts like a bridge between your body's immune cells (called T-cells) and the myeloma cells. By locking onto specific proteins on both cells, it encourages your immune system to destroy the cancer cells directly. In this trial, ramantamig is given together with daratumumab, an already approved drug for multiple myeloma.

The main goal is to find out whether combining ramantamig with daratumumab works better at controlling the cancer than the current standard treatment combinations. It also checks whether this combination causes fewer or milder side effects. The results could help shape future care for people living with multiple myeloma across the UK and worldwide.

Key takeaways

A Phase 3 study comparing a new immunotherapy drug (ramantamig) against standard treatments for multiple myeloma.
Aimed at adults newly diagnosed with multiple myeloma who cannot have a stem cell transplant.
Participants are randomly assigned to either the new treatment combination or current standard care.
Includes regular health checks, scans, and blood tests over approximately five years.
Participation is entirely voluntary, and all travel expenses related to the study are reimbursed.

Who may be eligible?

You may be able to join this study if you are 18 or older and have recently been diagnosed with multiple myeloma, but have not yet started any main treatment. The trial is designed specifically for people who are not planning to have high-dose chemotherapy with a stem cell transplant, often because of older age or other health conditions.

To take part, you must feel well enough to carry out daily activities with little or no help. You will also need to have measurable signs of myeloma in your blood or urine tests so doctors can track your progress.

You will not be able to join if you have already received treatment for multiple myeloma (apart from a very short emergency course of steroids), if the cancer has spread into your brain or spinal fluid, or if you have had major surgery within the last two weeks. People with severe allergies to the study medications are also not eligible.

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 recently been diagnosed with multiple myeloma.
I have not yet started treatment for my myeloma.
I am not planned or eligible to have a stem cell transplant.
I am generally able to walk and take care of my daily needs.

Answer every question to see your result.

What does participation involve?

If you decide to join, you will first have a screening period lasting up to 28 days to make sure the trial is safe for you. You will then be placed into one of two treatment groups by a computer programme, completely by chance. One group receives ramantamig plus daratumumab. The other group receives standard combination therapy chosen by your doctor (such as daratumumab, bortezomib, lenalidomide, and dexamethasone). Most medicines are given as injections, drips into a vein, or tablets.

Throughout the study, you will have regular hospital visits for physical exams, blood and urine tests, heart checks (ECGs), and discussions about how you are feeling. The trial will follow your progress for up to five years or longer. All study medicines and extra tests are provided free of charge, and you can claim back reasonable travel and parking costs.

Potential risks and benefits

There is no guarantee that taking part will improve your cancer, as ramantamig is still being tested. However, you will receive close medical monitoring, and the findings may help improve care for future patients. Like all cancer treatments, the medicines can cause side effects. These can include strong immune reactions (such as fever or flu-like symptoms), nerve changes, tiredness, low blood cell counts, and a higher risk of infections. Your medical team will monitor you closely and treat any side effects promptly. Taking part is completely voluntary, and you are free to leave the trial at any point without it affecting your standard medical care.

Locations (9)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Kent and Canterbury Hospital
Unverified
Canterbury, England
Blackpool Victoria Hospital
Unverified
Blackpool, England
New Cross Hospital
Unverified
Wolverhampton, England
Addenbrookes Hospital
Unverified
Cambridge, England
Western General Hospital
Unverified
Lothian, Scotland
University Hospital Bristol and Weston, Bristol Haematology and Oncology Centre
Unverified
Bristol, England
University College Hospital, Cancer Clinical Trials Unit
Unverified
London, England
University Hospitals Birmingham NHS Foundation Trust
Unverified
Birmingham, England
Colchester General Hospital
Unverified
Colchester, England

Common questions

Can I choose which treatment group I join?

No. A computer assigns you to a group by chance. This is called randomisation, and it ensures the study results are fair and reliable.

Will I have to pay for anything?

No. The trial drugs and any study-related tests are provided at no cost to you. You can also be reimbursed for reasonable travel and parking expenses.

How long will I be in the study?

Participation usually lasts around five years, covering the time you receive treatment and regular follow-up visits to check on your health.

What happens if I experience severe side effects?

Your safety comes first. The medical team will check you frequently. If you develop serious side effects, they can adjust your treatment, pause it, or stop it altogether.

What if I change my mind later on?

You can leave the trial at any time, for any reason. Your regular doctors will simply continue your care using the standard treatments available on the NHS.

How to find out more

- Medical Information and Product Information Enquiry

medinfo@its.jnj.com +44 800 731 8450 / 10494 567 444 Official trial record

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