RecruitingPHASE4INTERVENTIONAL

Elranatamab Post Trial Access Study for Participants With Multiple Myeloma (MM)

This study is for people in the UK who have multiple myeloma, a type of blood cancer, and are currently taking a medicine called elranatamab as part of an earlier research study. If the medicine is working well for them and their doctor believes they are still benefiting, this study allows them to keep receiving elranatamab. It's designed to make sure eligible patients can continue their treatment until it's no longer helping, becomes unsafe, or is available for wider use. This is called 'post-trial access' and bridges the gap between a research study ending and the medicine potentially becoming available in clinics.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Pfizer

Enrolment target

Start

03 Oct 2023

Estimated completion

22 Feb 2032

Multiple Myeloma

What is this study about?

This study is about a medicine called elranatamab for people who have multiple myeloma. Multiple myeloma is a cancer of the plasma cells, a type of white blood cell found in the bone marrow. People who are invited to join this study have already been taking elranatamab in a previous research study sponsored by Pfizer (the company that makes the medicine). They are still taking it because it has been helping them, and their doctors believe they are still getting a benefit from the treatment.

The main goal of this study is to allow these patients to continue receiving elranatamab. It's like a bridge, making sure that if the medicine is working for someone, they can keep taking it even after the original study finishes. This is often called 'post-trial access' and it's a way to ensure ongoing care for patients who respond well to new treatments during research.

You would continue to receive elranatamab for as long as it benefits you, doesn't cause severe side effects, or until it becomes widely available for doctors to prescribe in your country. This helps ensure that patients who are doing well on a promising treatment can continue their care without interruption.

Key takeaways

This study is for ongoing treatment with elranatamab.
It's only for people already benefiting from elranatamab in a previous study.
It provides a way to continue treatment after an earlier research study ends.
Eligible participants can keep receiving the drug, if beneficial, until it's widely available or no longer working.
Your health will be closely monitored throughout your participation.

Who may be eligible?

This study is only for people who have already been taking elranatamab as part of an earlier research study, often called a 'Parent Study.' To join this new study, you must have been receiving elranatamab when that earlier study ended or finished, and your doctor must believe that the medicine is still helping you.

There are also some important rules about birth control that you would need to agree to follow if you join. Your doctor will discuss these with you in detail.

You cannot join this study if you weren't in one of the previous elranatamab studies, or if you had to stop taking elranatamab in those studies. Also, if you have any other serious health problems, including mental health issues like suicidal thoughts within the last year, which your doctor thinks might make it risky for you to take part, then you wouldn't be able to join. The study is open to both men and women aged 18 years and older.

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.

Are you currently taking elranatamab as part of an earlier research study?
Does your doctor believe that elranatamab is still helping your multiple myeloma?
Were you still receiving elranatamab when that earlier study finished?
Are you willing to discuss and follow specific rules about birth control?
Do you have any serious health conditions that your doctor has not already cleared for study participation?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to receive the medicine elranatamab. Your doctor and the study team will monitor your health closely to make sure the medicine is still working and that you are not experiencing any serious side effects. You will stay on elranatamab until your multiple myeloma gets worse, you have side effects that make it unsafe to continue, you decide you no longer want to be part of the study, the study officially ends, or if elranatamab becomes available for doctors to prescribe outside of a research study in the UK. The study team will explain what check-ups and appointments will be needed while you are receiving the treatment.

Potential risks and benefits

The main potential benefit of joining this study is that you can continue to receive elranatamab, which your doctor believes is currently helping your multiple myeloma. This offers ongoing treatment that might keep your cancer under control for longer. As with any medicine, there are potential risks and side effects from elranatamab, which your medical team will discuss with you in detail, based on your previous experience with the drug. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (28)

UCHealth Poudre Valley Hospital
Verified postcode
Fort Collins, United States· Recruiting
UCHealth Harmony
Verified postcode
Fort Collins, United States· Recruiting
UCHealth Greeley Hospital
Verified postcode
Greeley, United States· Recruiting
Longs Peak Hospital
Verified postcode
Longmont, United States· Recruiting
UCHealth Longs Peak Medical Center
Verified postcode
Longmont, United States· Recruiting
UCHealth - Medical Center of the Rockies
Verified postcode
Loveland, United States· Recruiting
Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center
Verified postcode
Coral Gables, United States· Recruiting
University of Miami Hospital and Clinics Deerfield Beach
Verified postcode
Deerfield Beach, United States· Recruiting
Sylvester Comprehensive Cancer Center
Verified postcode
Miami, United States· Recruiting
University of Miami Hospital and Clinics - Griffin Cancer Research Building
Verified postcode
Miami, United States· Recruiting
University of Miami Hospital and Clinics
Verified postcode
Miami, United States· Recruiting
University of Michigan
Verified postcode
Ann Arbor, United States· Recruiting

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that affects plasma cells, which are a kind of white blood cell found in your bone marrow.

What is 'post-trial access'?

It means if a medicine you're taking in a research study is working well for you, you can keep getting it even after the original study has finished.

Who can join this study?

This study is only for people who are already taking elranatamab in a previous research study and whose doctor thinks it's still helping them.

How long will I receive the medicine?

You'll continue to receive elranatamab as long as it's helping you, doesn't cause serious side effects, or until it becomes available for others to get outside of a study.

Can I stop taking part if I want to?

Yes, you can choose to leave the study at any time, and it won't affect your regular medical care.

How to find out more

Pfizer CT.gov Call Center

clinicaltrials.gov_inquiries@pfizer.com 1-800-718-1021 Official trial record

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