Active not recruitingOBSERVATIONAL

Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE)

The PREAMBLE study is an important research project focusing on multiple myeloma, a type of blood cancer. Its main goal is to understand how well the currently approved treatments for this condition are working for patients in their daily lives, outside of highly controlled clinical trial settings. The study includes two main groups of patients: those who have been recently diagnosed with multiple myeloma and those whose condition has come back or hasn't responded to previous treatments. By observing how these treatments are used and their outcomes in real-world clinics, researchers hope to gain valuable insights into their effectiveness and help improve care for future patients. This is not a study testing new drugs, but rather observing current practices.

At a glance

Status

Active not recruiting

Sponsor

Bristol-Myers Squibb

Enrolment target

2,555

Start

13 Jun 2012

Estimated completion

31 Mar 2030

Multiple Myeloma

What is this study about?

The PREAMBLE study is an important observational study focusing on multiple myeloma, a cancer that affects plasma cells in the bone marrow. When you hear about clinical trials, you often think of testing new medicines. However, this study is different. It's an 'observational' study, which means researchers will simply be looking at and collecting information about how existing, approved multiple myeloma treatments are being used and how well they are working in standard medical care. They are not giving participants any new or experimental medications.

The main aim is to understand the effectiveness of all approved multiple myeloma therapies when used in real-world settings. This includes people who have just been diagnosed with multiple myeloma (NDMM) and those who have already had treatment but their myeloma has come back or hasn't responded as expected (RRMM). By gathering this information, the study hopes to provide a clearer picture of how these treatments perform outside of very structured research environments, which can be incredibly useful for doctors and patients.

Ultimately, the insights gained from an observational study like PREAMBLE can help healthcare professionals better understand which treatments are most effective for different groups of patients in everyday practice. This could lead to improved treatment choices and better care for people living with multiple myeloma in the future.

Key takeaways

It's an observational study, not testing new drugs.
Aims to understand real-world effectiveness of multiple myeloma treatments.
Includes both newly diagnosed and previously treated patients.
Your treatment decisions remain with your doctor.
Low direct risk, as you're receiving standard care.
Your participation helps improve future care for others.

Who may be eligible?

To take part in this study, you would need to be an adult aged 18 or over. This study is for people who have multiple myeloma.

If you have been diagnosed with multiple myeloma and your condition has either come back or hasn't responded to previous treatments, you might be eligible if you've had at least one prior line of therapy. You should also have started or be about to start certain approved treatments for multiple myeloma (such as IMiDs, PIs, or newer combination therapies and agents like CAR T-cell therapies) within a certain timeframe around joining the study.

If you have been newly diagnosed with multiple myeloma and haven't had any prior treatment for it, you might also be eligible. Similar to the other group, you would need to have started or be about to start certain standard frontline multiple myeloma treatments within a specific timeframe around joining the study. You cannot take part if you are currently in another clinical trial for multiple myeloma or receiving treatment for another type of cancer apart from multiple myeloma.

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 18 years old or older?
Do you have multiple myeloma?
Are you currently receiving or about to start an approved multiple myeloma treatment?
Are you NOT currently in another clinical trial for multiple myeloma?
Are you NOT currently being treated for another primary cancer (other than multiple myeloma)?

Answer every question to see your result.

What does participation involve?

As this is an observational study, you would continue to receive your standard medical care and treatments as prescribed by your doctor for multiple myeloma. The study involves collecting information about your treatment, how your condition progresses, and your general health, usually from your existing medical records and potentially through some additional visits or questionnaires.

There are no experimental medications or specific new interventions given as part of this study. Your doctor will make all decisions about your treatment. The study team will simply observe and record the details of your care and its outcomes. The exact number of visits and the total duration aren't specified here, but typically, observational studies involve data collection over a period, which could range from months to a few years, depending on the research questions.

Potential risks and benefits

The potential benefits of taking part in this study are indirect. By providing information about your experience, you contribute to a better understanding of multiple myeloma treatments in the real world, which could help future patients. As an observational study, it generally carries low direct risks, as you are not undergoing experimental treatments or procedures that are outside of your usual care. The main burden would be the time involved in providing informed consent and potentially for data collection. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (130)

Local Institution
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Birmingham, United States
Local Institute
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Goodyear, United States
Local Institution - 0023
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Anaheim, United States
Local Institution
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Anaheim, United States
Local Institution - 0045
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Burbank, United States
Local Institution
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Corona, United States
Local Institution - 0048
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Downey, United States
Local Institution - 0052
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Fountain Valley, United States
Local Institute
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Los Angeles, United States
Local Institute
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Santa Rosa, United States
Local Institution - 0051
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Santa Rosa, United States
Local Institution
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Brooksville, United States

Common questions

What is an 'observational study'?

An observational study means researchers watch and collect information about how current treatments are working in real life, without giving new drugs or changing your care.

Will I receive new medicine in this study?

No, this study is about observing how approved multiple myeloma treatments work. You will continue to receive your standard care from your doctor.

Who is eligible for this study?

Adults (18+) with multiple myeloma, either newly diagnosed or whose condition has returned/not responded to previous treatment, who are receiving certain approved therapies.

How long will I be in the study?

The duration isn't specified, but observational studies typically collect data over months or years, depending on the research questions.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, and this will not affect the medical care you receive.