Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A MULTICENTER, RANDOMIZED, OPEN LABEL PHASE II STUDY OF CARFILZOMIB, CYCLOPHOSPHAMIDE AND DEXAMETHASONE (CCyd) as pre transplant INDUCTION and post transplant consolidation or CARFILZOMIB, LENALIDOMIDE AND DEXAMETHASONE (CRd) as pre transplant INDUCTION and post transplant consolidation or continuous treatment with CARFILZOMIB, LENALIDOMIDE AND DEXAMETHASONE (12 cycles) without transplant, all followed by MAINTENANCE with LENALIDOMIDE (R) versus LENALIDOMIDE AND CARFILZOMIB (CR) IN NEWLY DIAGNOSED MULTIPLE MYELOMA (MM) PATIENTS ELEGIBLE FOR AUTOLOGOUS TRANSPLANT

This study is for adults newly diagnosed with multiple myeloma who are healthy enough for a stem cell transplant. It compares different treatment plans to find the best way to manage their cancer. Some patients will receive a combination of drugs (carfilzomib, cyclophosphamide, and dexamethasone) or another combination (carfilzomib, lenalidomide, and dexamethasone), both before and after a stem cell transplant. Other patients will receive the carfilzomib, lenalidomide, and dexamethasone combination for a longer period without a transplant. All groups will then have ongoing treatment with lenalidomide, or lenalidomide and carfilzomib. The main goal is to see how well these treatments control the cancer and how long patients stay healthy without the cancer getting worse.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Universita' Degli Studi Di Torino

Enrolment target

477

Start

21 Jan 2025

NEWLY DIAGNOSED MULTIPLE MYELOMA (MM) PATIENTS ELEGIBLE FOR AUTOLOGOUS TRANSPLANT

What is this study about?

This research study is looking at several different ways to treat a type of cancer called multiple myeloma, specifically in people who have been recently diagnosed with it. Multiple myeloma affects plasma cells, a type of white blood cell found in your bone marrow.

The study wants to find out which treatment approach works best. It compares a few different plans: some involve strong initial treatment with drugs, followed by a stem cell transplant, and then ongoing maintenance treatment. Other plans involve strong initial drug treatment for a longer time, but without a stem cell transplant. All participants will then move on to a continuous treatment phase to help keep the cancer in check. Scientists want to see which of these ways of combining treatments leads to the best outcomes for patients.

The main things the researchers are checking are how well the treatments shrink the cancer and how long patients remain healthy without their cancer growing or returning. They're also looking closely at how many patients achieve a very good response, where the cancer is barely detectable. By comparing these different approaches, they hope to improve future treatments for multiple myeloma.

Key takeaways

This study is for newly diagnosed multiple myeloma patients eligible for an autologous stem cell transplant.
It compares different treatment plans, with and without a stem cell transplant.
All treatment plans include various drug combinations and a maintenance phase.
The main goal is to find better ways to control the cancer and improve long-term outcomes.
Participation involves taking new medications, regular check-ups, and potentially a stem cell transplant.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for adults who have recently been diagnosed with multiple myeloma. This means you haven't received treatment for your multiple myeloma before participating in this trial.

To be considered, you also need to be well enough to have a type of treatment called an autologous transplant. This is a procedure where your own stem cells are collected and then given back to you after high-dose chemotherapy.

There isn't an upper age limit for this study, as long as your doctors believe you are generally healthy enough to take part and manage the treatments involved.

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 I recently been diagnosed with multiple myeloma (not treated before)?
Am I generally healthy enough to consider a stem cell transplant?
Am I 18 years old or older?
Am I open to receiving different combinations of medications, potentially including a stem cell transplant?
Am I able to attend regular hospital appointments for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive one of several specially designed treatment plans. This will involve taking different medications, either as pills (like Revlimid) or as infusions (like Kyprolis, which is given into a vein). The treatment is typically given in cycles, with periods of taking medication followed by rest periods.

Depending on the group you're in, your treatment might include a stem cell transplant. This is a common treatment for multiple myeloma and involves collecting your healthy stem cells, having high-dose chemotherapy, and then having your stem cells returned to you.

You'll have regular hospital visits for check-ups, blood tests, and to receive your treatments. These visits will help the doctors monitor how you're responding to the treatment and manage any side effects. After the main treatment, you'll continue with maintenance medication and follow-up appointments. The total duration of your involvement could be several years, including the ongoing maintenance phase.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as gaining access to new treatments before they are widely available, and closely monitored medical care. You would also be contributing to medical knowledge that could help future patients. However, there are also potential risks; the treatments might cause side effects, and they might not work for everyone. Always remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Italy

Common questions

What is 'multiple myeloma'?

Multiple myeloma is a cancer that affects specific white blood cells (plasma cells) found in your bone marrow, which is the spongy tissue inside your bones.

What does 'autologous transplant eligible' mean?

It means you are healthy enough to have a stem cell transplant using your own healthy stem cells, which is a common treatment for multiple myeloma.

What are the main goals of this study?

The study aims to find out which combination of treatments works best at controlling multiple myeloma and how long patients stay healthy without the cancer getting worse.

Will I definitely get a stem cell transplant if I join?

Not necessarily. Some parts of the study include a transplant, while others explore treatment without one. You would be assigned to one of these groups.

What does 'maintenance treatment' involve?

After your initial treatment, you'll receive ongoing medication (like Revlimid, or Revlimid and Kyprolis) to help keep your cancer in remission for as long as possible.