Active not recruitingPHASE1INTERVENTIONAL

A Study Evaluating the Safety, Pharmacokinetics, and Activity of Cevostamab in Participants With Relapsed or Refractory Multiple Myeloma

This research study is testing a new treatment called Cevostamab for people battling multiple myeloma that has either returned or hasn't improved with other treatments. It's a 'Phase 1' study, which means it's an early stage where doctors are mainly checking if the drug is safe and well-tolerated. They also want to understand how the body handles Cevostamab and if it shows any signs of helpful activity. Participants will receive Cevostamab on its own, or combined with other common multiple myeloma medicines like Pomalidomide and Dexamethasone, or Daratumumab and Dexamethasone. All treatments will be given directly into the bloodstream.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Genentech, Inc.

Enrolment target

126

Start

26 Jul 2021

Estimated completion

10 Dec 2029

Multiple Myeloma

What is this study about?

This study is testing a new medicine called Cevostamab for people who have multiple myeloma. Multiple myeloma is a type of cancer that affects plasma cells, which are found in your bone marrow. Sometimes, treatments don't work as well as hoped, or the cancer comes back. This is called 'relapsed or refractory multiple myeloma'. The main goal of this study is to see if Cevostamab is safe when given to people with this condition. Because it's a new drug, understanding its safety is the first and most important step.

The study also wants to find out how Cevostamab works in the body – how long it stays, how it's broken down, and whether it has any effects on the cancer. Participants might receive Cevostamab by itself, or in combination with other medicines that are already used to treat multiple myeloma, such as Pomalidomide and Dexamethasone, or Daratumumab and Dexamethasone. Giving a new drug with existing treatments can sometimes make them work better together.

All participants will receive the treatment through a drip into a vein. This study is important because it could lead to new treatment options for people with multiple myeloma who haven't had success with current therapies. By carefully looking at how this new drug works, researchers hope to improve future treatments for this condition.

Key takeaways

This study is testing a new drug, Cevostamab, for multiple myeloma that has returned or not responded to previous treatments.
It's an early-stage study primarily focused on checking the safety of Cevostamab.
The drug will be given into your vein, sometimes alone and sometimes with other standard myeloma medicines.
Regular health checks and bone marrow samples will be needed to see how the treatment is working and monitor your safety.
You must meet specific health criteria and agree to birth control if you could have children, to participate.

Who may be eligible?

To join this study, people generally need to be in reasonably good health, able to carry out daily activities with little difficulty, and expected to live for at least 12 weeks. You would also need to have multiple myeloma that has either come back or hasn't responded to previous treatments, and your cancer must still be measurable so doctors can track any changes.

There are specific rules for women who could become pregnant and men. If you're a woman, you must agree to either avoid sex or use reliable birth control during the study and for several months after your last dose of medication. If you're a man, you must agree to either avoid sex or use a condom, and not donate sperm, during the study and for some time after your last dose. This is to make sure your partner or any potential baby isn't exposed to the study drugs.

For some parts of the study, you might need to have received a certain number of previous treatments for your multiple myeloma. The study also requires you to agree to provide bone marrow samples, which help doctors understand how the treatment is working.

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 that has returned or hasn't responded to previous treatments?
Are you generally well enough to do most everyday activities?
Are you able to commit to using birth control or avoiding sex if needed (for both men and women)?
Are you willing to provide bone marrow samples?
Have any side effects from your past treatments mostly gone away (to a mild level or better)?

Answer every question to see your result.

What does participation involve?

Taking part in this study means you will receive the experimental drug, Cevostamab, which will be given as a drip into your vein. Depending on which group you are in, you might also receive other standard multiple myeloma medications like Pomalidomide, Daratumumab, and Dexamethasone, also administered into your vein or as tablets. You will have regular appointments for check-ups, blood tests, and other assessments to monitor your health and how the treatment is working. This will include providing bone marrow samples.

The study is 'open-label', meaning both you and your study doctor will know which treatment you are receiving. The total length of your participation will depend on how you respond to the treatment and the safety monitoring required, but it will involve ongoing visits for drug administration and health assessments. There will also be a follow-up period after your last dose to continue monitoring your safety.

Potential risks and benefits

Participating in any clinical trial, including this one, involves potential benefits and risks. A potential benefit of this study is that you might receive a new treatment, Cevostamab, that could help manage your multiple myeloma, especially if other treatments haven't worked well. However, because this is an early-stage study, the main goal is to find out if the drug is safe, and we don't yet know how effective it will be. There are risks associated with any new medication, and Cevostamab may cause side effects that are not yet fully known. Your study team will discuss all known potential side effects with you and monitor you closely. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (26)

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

City of Hope
Verified postcode
Duarte, United States
City of Hope - Lennar Foundation Cancer Center
Verified postcode
Irvine, United States
Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center
Verified postcode
Denver, United States
Karmanos Cancer Institute.
Verified postcode
Detroit, United States
Washington University School of Medicine
Verified postcode
St Louis, United States
Peter MacCallum Cancer Centre
Verified postcode
Melbourne, Australia
The Alfred Hospital
Verified postcode
Melbourne, Australia
Cross Cancer Institute
Verified postcode
Edmonton, Canada
Hamilton Health Sciences
Verified postcode
Hamilton, Canada
University Health Network
Verified postcode
Toronto, Canada
Fakultni Nemocnice Ostrava
Verified postcode
Ostrava, Czechia
Rigshospitalet
Verified postcode
København Ø, Denmark

Common questions

What is multiple myeloma?

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

What does 'relapsed or refractory' mean?

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

What is Cevostamab?

Cevostamab is a new drug being tested in this study to see if it can help treat multiple myeloma.

What is a 'Phase 1' study?

A Phase 1 study is usually the first time a new drug is tested in people. The main aim is to check its safety and find the right dose, rather than focusing on how well it treats the disease yet.

Will I know if I'm getting Cevostamab or another drug?

Yes, this is an 'open-label' study, which means both you and your doctors will know exactly which medicines you are receiving.