Active not recruitingOBSERVATIONAL

Clinical Decision-making, Prognosis, Quality of Life and Satisfaction in Relapsed/Refractory Multiple Myeloma

This research is investigating people with multiple myeloma, a type of blood cancer, where treatments haven't worked as expected or the cancer has returned. The main goal is to understand if how a patient feels and reports their quality of life, particularly their level of tiredness, can predict their overall survival. This is important because while new treatments exist, they often have side effects that can impact daily life. Currently, there isn't much information on how patient feelings and experiences (known as patient-reported outcomes) are linked to how well people do in the long term, especially in this group of patients. The study aims to fill this gap by looking at existing information to see if these patient reports could be a useful tool for doctors.

At a glance

Status

Active not recruiting

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Enrolment target

530

Start

13 Nov 2017

Estimated completion

01 Dec 2025

Multiple Myeloma

What is this study about?

This study is about multiple myeloma, a type of cancer that affects plasma cells in the bone marrow. Specifically, it focuses on patients whose cancer has either come back after treatment or isn't responding to treatment anymore. These situations can be challenging, and while there are new medicines, they often come with side effects that can make everyday life difficult. This research is important because it's trying to understand something really personal: how a patient's own feelings about their health and well-being connect with their journey with the illness.

The main idea behind this study is to see if a patient's reported quality of life – things like how tired they feel – can help doctors understand how their illness might progress. Think of it like this: if you tell your doctor you're extremely tired, could that be an important sign about your overall health alongside other medical tests? Up until now, most studies have focused on the medical side of things. This research hopes to show that what patients experience and report can also give valuable clues about their prognosis (how the disease is likely to develop).

Doctors are keen to learn if these personal reports, known as 'patient-reported outcomes,' can be a useful tool for making decisions and planning care for people with this type of myeloma. It's about looking at the full picture, not just the test results, but also how the illness affects a person's daily life and overall well-being. This information could help doctors provide more personalised care and support for patients.

Key takeaways

This study focuses on multiple myeloma that has come back or is hard to treat.
It's trying to see if how you feel (your quality of life) can predict how your illness progresses.
Participation mainly involves answering questionnaires about your well-being.
No new medications or treatments are being given in this study.
Your input could help doctors better understand and care for future patients.

Who may be eligible?

To be part of this study, you would need to be an adult, aged 18 or older, and have multiple myeloma that has come back or isn't responding well to at least one previous treatment. The doctors use specific criteria to confirm this. You would also need to be able to understand the study and agree in writing to take part. Even if you're already in another research study, you might still be able to join this one, as long as you've completed an initial quality of life questionnaire.

There are also some reasons why you might not be able to participate. For example, if you have a mental health condition or a significant problem with your memory or thinking that would make it hard for you to understand and agree to the study. Also, if you've had a serious side effect from treatment (grade 3 or higher) within two weeks before the study starts, or if you've already had more than five different types of treatment for your myeloma, you wouldn't be able to join.

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 old or older.
I have multiple myeloma that has come back or isn't responding well to treatment.
I am able to understand and agree to take part in the study.
I haven't had more than five different types of treatment for my myeloma previously.

Answer every question to see your result.

What does participation involve?

This study primarily involves reviewing existing patient information. If you were participating, it would mainly involve completing 'quality of life questionnaires'. These questionnaires ask you about how you are feeling and how your illness impacts your daily life. There is no medication being tested in this particular study, and it doesn't involve any new treatments or procedures. The aim is to understand the link between your self-reported feelings and your health outcomes. The study duration is not specified but usually involves collecting information at different points in your treatment journey.

Potential risks and benefits

Participating in research studies always has potential benefits and risks. For this specific study, a potential benefit is that the information gathered from your experiences could help doctors better understand similar patients in the future, ultimately improving care for others. Since this study mainly involves questionnaires and reviewing existing data, the risks are generally low. However, you might find some questions about your health and well-being personal or emotionally challenging. You are always free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (35)

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

Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. LANCISI - G. SALESI
Verified postcode
Ancona, Italy
S. Orsola Malpighi
Verified postcode
Bologna, Italy
Divisione di Ematologia Ospedale A. Perrino
Verified postcode
Brindisi, Italy
ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO
Verified postcode
Cagliari, Italy
Unità di Onco-Ematologia - Azienda Ospedaliera - Garibaldi
Verified postcode
Catania, Italy
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
Verified postcode
Catania, Italy
Unità Operativa Oncologia Medica - A.O. Pugliese Ciaccio
Verified postcode
Catanzaro, Italy
Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi
Verified postcode
Cona, Italy
U.O. Ematologia - P.O. Annunziata - A.O. di Cosenza
Verified postcode
Cosenza, Italy
Unità di Ricerca e di Malattie del sangue - Ematologia San Luca Vecchio Pad. 16 - 1° Piano
Verified postcode
Florence, Italy
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
Verified postcode
Lecce, Italy
Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina
Verified postcode
Messina, Italy

Common questions

What is 'multiple myeloma'?

It's a type of cancer that starts in the plasma cells in your bone marrow, which are a type of white blood cell.

What does 'relapsed/refractory' mean?

It means the cancer has come back after treatment (relapsed) or it hasn't responded to treatment as expected (refractory).

What are 'quality of life questionnaires'?

These are forms where you answer questions about how your illness and treatment affect your daily life, feelings, and general well-being.

Will I receive new treatment in this study?

No, this study is about understanding how patients feel and how that relates to their health, not about testing a new medicine.

Can I stop participating if I change my mind?

Yes, you have the right to withdraw from the study at any time, for any reason, without affecting your medical care.