RecruitingOBSERVATIONAL

A Study of Real-Life Current Standards of Care in Participants With Relapsed and/or Refractory Multiple Myeloma

This study is designed to understand how current standard treatments for multiple myeloma work in everyday medical practice. It focuses on people whose multiple myeloma has returned or hasn't responded to earlier treatments (this is called relapsed and/or refractory multiple myeloma). Over a two-year period, researchers will observe how effective these treatments are, how safe they are, and how they impact patients' quality of life. Importantly, this isn't a study where new drugs are tested; instead, it simply observes the results of treatments already in use that doctors would prescribe anyway. This helps us learn more about the real-world experiences of people living with this condition.

At a glance

Status

Recruiting

Sponsor

Janssen Pharmaceutica N.V., Belgium

Enrolment target

300

Start

18 Nov 2021

Estimated completion

31 Jul 2028

Relapsed/Refractory Multiple Myeloma

What is this study about?

This study is looking at how well different treatments for multiple myeloma, a type of blood cancer, are working for people whose cancer has either come back or hasn't responded to previous treatments. This is often called 'relapsed and/or refractory' multiple myeloma. Instead of testing a new medicine, the researchers want to understand what happens when patients receive the 'standard care' — that is, the treatments that doctors already widely use and recommend.

Over two years, the study will collect information on patients' health, how safe the treatments are, and how patients feel about their treatment outcomes. This includes things like their day-to-day well-being and how their symptoms are managed. By observing actual patient experiences, doctors and researchers can get a clearer picture of how these standard treatments perform in real-world settings, outside of highly controlled clinical trials.

The main goal is to gain a better understanding of the journeys of people with relapsed and/or refractory multiple myeloma and the effects of their current treatment plans. This information can help improve how patients are cared for in the future.

Key takeaways

This study observes real-life treatments for multiple myeloma.
It focuses on patients whose cancer has returned or didn't respond to earlier treatments.
No new medicines are given; standard care is simply monitored.
The study tracks how effective treatments are and how patients feel over two years.
Your doctor decides your treatment, participation doesn't change it.
Your contribution helps improve understanding of multiple myeloma care.

Who may be eligible?

To be part of this study, you must have been diagnosed with multiple myeloma. If your multiple myeloma has come back or hasn't responded to previous treatments, you would be considered, especially if your doctor is planning to start you on a specific medication called talquetamab, or if you've recently started it within a few weeks before joining the study.

Generally, you should be able to carry out your daily activities without much difficulty, scoring a 0, 1, or sometimes 2 on a scale that measures your general well-being (called ECOG Performance Status). You must also be at least 18 years old. Importantly, you should not be pregnant or planning to become pregnant during the study.

For some parts of the study, you would need to have had at least three different types of treatment for your multiple myeloma in the past. You also need to show signs that your multiple myeloma is still active or has worsened on your current treatment, even after trying previous therapies.

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.

Have you been diagnosed with multiple myeloma?
Has your multiple myeloma either come back or not responded well to past treatments?
Are you able to manage your daily activities reasonably well (ECOG 0, 1, or 2)?
Are you at least 18 years old?
Are you not pregnant and not planning to become pregnant during the study period?
Are you about to start, or have recently started, a treatment called talquetamab, or have you had at least 3 previous lines of myeloma treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't be given any new or experimental medications. Instead, the study will simply observe the treatment you are already receiving or about to start as part of your usual care for multiple myeloma. This means you will continue to see your own doctors and receive your prescribed treatments as normal.

Over a period of two years, the research team will collect information from your medical records about your treatment, how it's affecting your multiple myeloma, and any side effects you might experience. You will also be asked to share how you are feeling and how the treatment is impacting your daily life through regular questionnaires.

There are no extra hospital visits or procedures specifically for this study. The information collected will come from your routine doctor appointments and your own reports, making it a very low-impact way to contribute important data about living with multiple myeloma.

Potential risks and benefits

Since this study only observes the treatments you would normally receive, there are no additional medical risks from participating beyond those associated with your existing medical care. You will not be given any new or different treatments because of this study. A potential benefit is that the information gathered from your experience can help doctors and researchers better understand multiple myeloma and its treatments, potentially leading to improved care for others in the future. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (87)

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

LKH Leoben
Verified postcode
Leoben, Austria· Recruiting
Krankenhaus der barmherzigen Schwestern
Verified postcode
Vienna, Austria· Recruiting
UZ Antwerpen
Verified postcode
Edegem, Belgium· Recruiting
Ziekenhuis Oost-Limburg
Verified postcode
Genk, Belgium· Recruiting
UZ Leuven
Verified postcode
Leuven, Belgium· Completed
Chu Helora Hospital De Mons Site Kennedy
Verified postcode
Mons, Belgium· Recruiting
Vitaz
Verified postcode
Sint-Niklaas, Belgium· Recruiting
Ucl de Mont-Godinne
Verified postcode
Yvoir, Belgium· Completed
CHRU de Lille Hopital Claude Huriez
Verified postcode
Lille, France· Completed
CHU de Montpellier Hopital Saint Eloi
Verified postcode
Montpellier, France· Completed
CHU de Nantes hotel Dieu
Verified postcode
Nantes, France· Completed
Centre hospitalier Lyon-Sud
Verified postcode
Pierre-Bénite, France· Completed

Common questions

What is 'standard care'?

Standard care refers to the treatments that are widely accepted and used by doctors for your condition, based on current medical guidelines.

Will I get a new medicine in this study?

No, this study only observes the treatments you would be getting anyway from your doctor. You won't receive any new or experimental drugs.

How long will I be in the study?

The study will follow your progress for up to two years.

What does 'relapsed and/or refractory' mean?

This means your multiple myeloma has either come back after treatment or hasn't responded well to previous treatments you've had.

Will my privacy be protected?

Yes, all your personal information will be kept confidential and handled according to strict privacy rules.

How to find out more

Study Contact

participate-in-this-study1@its.jnj.com 844-434-4210 Official trial record

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