AuthorisedTherapeutic confirmatory (Phase III)Interventional

C1071015 - ELRANATAMAB POST TRIAL ACCESS: AN OPEN-LABEL, SINGLE-ARM STUDY FOR PARTICIPANTS WITH MULTIPLE MYELOMA CONTINUING FROM PFIZER-SPONSORED ELRANATAMAB CLINICAL STUDIES

This study, named C1071015, is designed for individuals with a type of blood cancer called multiple myeloma. It's specifically for those who are already receiving a medicine called elranatamab through a Pfizer-sponsored clinical trial and need to continue this treatment. The main goal is to allow these patients to keep taking elranatamab, which is in its final stages of testing (Phase III). Doctors will closely monitor participants for any side effects, including those that might lead to stopping the treatment, or any serious health problems. This ensures patients can continue accessing a promising new treatment while researchers gather more important safety information.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Pfizer Inc.

Enrolment target

Start

15 Nov 2023

Multiple myeloma

What is this study about?

This study, known as C1071015, is for people living with multiple myeloma, a type of cancer that affects plasma cells in the bone marrow. If you've been taking a new medicine called elranatamab as part of a Pfizer-sponsored clinical trial, and that trial is coming to an end, this study allows you to continue receiving the treatment.

Think of it as a way to bridge the gap. When a drug is still being researched, it's often given through clinical trials. Once those trials finish, sometimes patients who are benefiting from the medicine need a way to keep getting it. This study provides that pathway, ensuring continuity of care for those who are already on elranatamab.

The main purpose of this study is to make sure people can keep getting elranatamab. While you continue receiving the treatment, your doctors will also carefully watch for any side effects, especially those that are serious or might lead you to stop the medication. This helps researchers gather more important safety information about elranatamab over a longer period.

Key takeaways

This study is for people with multiple myeloma already taking elranatamab.
It helps you continue getting the treatment after your first study ends.
Doctors will closely monitor your health and any side effects.
The study is in its final phase of testing (Phase III).
You must be 18 years or older to participate.

Who may be eligible?

To join this study, you must be at least 18 years old. There is no upper age limit, meaning older adults are welcome to participate. This study is open to both men and women.

The most important requirement is that you must already be taking elranatamab as part of a previous clinical trial sponsored by Pfizer. This study is not for people who haven't received elranatamab before; it's a way for current participants to continue their treatment.

Quick self-check

Are you 18 years old or older?
Do you have multiple myeloma?
Are you currently receiving elranatamab as part of another Pfizer-sponsored clinical study?
Are you able to attend regular clinic visits for monitoring?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will continue to receive the medicine elranatamab. You will likely have regular visits to your clinic or hospital for check-ups. During these visits, doctors will monitor your health, check for any side effects, and perform assessments to see how you are responding to the treatment. This will involve physical examinations and possibly blood tests.

The exact number and type of visits, along with the total duration of your participation, will depend on your individual treatment plan and how you are responding. The study aims to allow you to continue receiving elranatamab as long as it is benefiting you and you are not experiencing significant side effects. There will also be follow-up observations to make sure you are doing well.

Potential risks and benefits

A potential benefit of joining this study is that you can continue to receive elranatamab, a treatment you are already using for multiple myeloma, which may be helping your condition. As with any medication, there are potential risks, mainly related to the side effects of elranatamab, which your doctors will monitor closely. You have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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France
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Spain
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Germany

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that starts in the plasma cells, which are part of your immune system and found in the bone marrow.

What is elranatamab?

Elranatamab is a medicine being tested for its ability to treat multiple myeloma. This study allows participants to continue using it.

Why is this study happening?

This study allows people already receiving elranatamab in another Pfizer trial to continue their treatment after that study finishes.

Will I have to pay to be in this study?

No, you will not have to pay for the study medication or any study-related procedures.

Can I stop participating in the study at any time?

Yes, you are free to withdraw from the study at any point, and it will not affect your medical care.