A clinical trial to look at the safety and early activity of cevostamab at different doses in people with multiple myeloma after other treatments have not worked

An open-label, multicenter, Phase Ib trial evaluating the safety, pharmacokinetics, and activity of subcutaneous cevostamab (BFCR4350A) in patients with relapsed or refractory multiple myeloma

  • Multiple Myeloma
Trial Status:

Not yet recruiting

This trial runs in
Countries
  • Australia
  • Belgium
  • Greece
  • Italy
  • Korea, Republic of
Trial Identifier:

GO43227

      Show trial locations

      The source of the below information is the publicly available website ISRCTN.com. It has been summarised and edited into simpler language.

      The below information is sourced from the publicly available website ISRCTN.com and has not been edited.

      Results Disclaimer

      Trial Summary

      The purpose of this study is to evaluate the safety and tolerability of subcutaneous (SC) cevostamab, including estimation of the maximum tolerated dose (MTD), characterization of dose-limiting toxicity (DLTs), and to identify the recommended phase II dose (RP2D) of SC cevostamab in participants with relapsed or refractory multiple myeloma (R/R MM)

      F. Hoffmann-La Roche (Switzerland) Sponsor
      GO43227 Trial Identifier
      Both Gender
      ≥18 Years Age
      No Healthy Volunteers

      The aim of this document is to give people interested in this clinical trial the background, treatment plan, scope of participants who are able to take part, benefits and risks. We recommend that this should be read carefully by potential participants and shared with close family members and caregivers. 

      Why is the clinical trial needed?

      Multiple myeloma (MM) is a type of bone marrow cancer. In cases where a person's cancer comes back after treatment (relapsed MM) or does not respond to treatment (refractory MM), other treatment options are needed. Researchers hope that using drugs, like cevostamab, designed to help a person's own immune system target and destroy cancer cells, will provide better health outcomes for people living with relapsed or refractory MM. 

       

      How does the clinical trial work?

      This clinical trial is recruiting people who have been diagnosed with relapsed or refractory MM.

      The purpose of the clinical trial is to test the safety of cevostamab, delivered as an injection into the layer between the skin and the muscle (subcutaneously) at different doses, and to understand the way the body responds to and processes cevostamab. This trial will also look at how well cevostamab treats relapsed or refractory MM. These results will then be used to help doctors decide which dose to give to people living with relapsed or refractory MM in future clinical trials.

      Participants will be given cevostamab, the clinical trial treatment, for up to one year. Participants will have a follow-up visit approximately one month after receiving their last dose of cevostamab, or after starting a new anti-cancer treatment, whichever happens first. Participants who complete 13 cycles of treatment will continue to have follow-up assessments until disease progression, start of new anti-cancer therapy, or withdrawl from clinical trial participation, whichever happens first.  

      The clinical trial is split up into 13 periods called "cycles", each lasting 28 days. In Cycle 1 (at a minimum), participants will need to stay in hospital for at least three days (72 hours) after each of the three injections of cevostamab to be monitored for side effects. Participants will be seen by the clinical trial doctor every two weeks during Cycles 2-6, then every four weeks during Cycles 7-13. These hospital visits will include medical tests to see how the participant is responding to the treatment and any side effects they may be experiencing. Participants are free to stop taking the trial treatment and leave the clinical trial at any time. 

       

      What are the main endpoints of the clinical trial?

      The main clinical trial endpoints (the main results that are measure in the trial to see if the medicine has worked and whether it is safe) are: the number and seriousness of any side effects experienced by the participant while taking the trial treatment, and the relationship between cevostamab dose and its safety profile. 

      Other clincal trial endpoints include:

      • How well, how quickly and for how long a participant's MM responds to cevostamab treatment;
      • How long before a participant's MM cancer gets worse;
      • How long a participant survives; and 
      • How the levels of cevostamab in the blood affect the body and how the immune system responds to cevostamab.

       

      Who can take part in this clincal trial?

      People can take part in this trial if they are at least 18 years old, have been diagnosed with relapsed or refractory MM, and have no alternative treatment options.

      People may not be able to take part in this trial if they have previously received certain cancer treatments, are pregnant or breastfeeding, or are planning to become pregnant, or have a history of autoimmune disease, severe allergies, or certain other medical conditions. 

       

      What treatmnet will participants be given in this clinical trial?

      This is an open-label trial, which means everyone involved, including the participants and the doctors, know which medicine is being used to treat each participant. Everyone who joins this clinical trial will be given cevostamab as an injection in the tissue layer between the skin and muscle for up to 13 cycles of 28 days:

      • In Cycle 1, some participants will join a 'dose escalation phase', where they will receive step-up (increasing) doses of cevostamab on Day 1, Day 8, and Day 15 (recommended target dose reached on Day 15)
      • In Cycles 2-6, participants will receive the target dose of cevostamab every two weeks
      • In Cycles 7-13, participants will receive the target dose of cevostamab every four weeks
      • This will be followed by an 'expansion phase' to further understand the safety and activity of cevostamab at step-up and recommended target doses. One or more expansion phase groups may be opened in order to, for example, test a combination of step-up versus target doses.

      If a participant experiences a potential side effect called 'cytokine release syndrome' (when the body's immune cells are activated and release large amounts of inflammatory substances throughout the body), they may receive another medicine called tocilizumab.

       

      Are there any risks or benefits in taking part in this clinical trial?

      The safety or effectiveness of the trial treatment or its use may not be fully known at the time of the trial. Most trials involve some risks to the participant, although it may not be greater than the risks related to routine medical care or the natural progression of the health condition. Potential participants will be told about any risks and benefits of taking part in the clinical trial, as well as any additional procedures, tests, or assessments they will be asked to undergo. These will all be described in an informed consent document (a document that provides people with the information they need to make a decision to volunteer for a clinical trial). A potential participant should also discuss these with members of the research team and with their usual healthcare provider. Anyone interested in taking part in a clinical trial should know as much as possible about the trial and feel comfortable asking the research team any questions about the trial.

      Risks associated with the clinical trial drugs

      Participants may have side effects (an unwanted effect of a drug or medical treatment) from the drugs used in this clinical trial. Side effects can be mild to severe and even life-threatening, and can vary from person to person.

      • Cevostamab: Potential participants will be told about the known side effects of cevostamab, and where relevant, also potential side effects based on human and laboratory studies or knowledge of similar drugs. Cevostamab will be given by subcutaneous injection (involves inserting a short needle into the tissue layer between the skin and the muscle of, for example, the abdomen or upper thigh). Participants will be told about any known side effects of subcutaneous injection.
      • Tocilizumab: Potential participants will be told about the known side effects of tocilizumab, and where relevant, also potential side effects based on human and laboratory studies or knowledge of similar drugs. Tocilizumab will be given by intravenous infusion (involves inserting a needle into a vein to allow the medicine to enter the bloodstream right away). Participants will be told about any known side effects of intravenous infusions.

      Potential benefits associated with the clinical trial

      Participants' health may or may not improve from participation in the clinical trial, but the information that is collected may help other people who have a similar medical condition in the future.

       

      For more information about this clinical trial see the ForExpert tab on the specific ForPatients page or follow this link to the ISRCTN registry: https://www.isrctn.com/ISRCTN26168155.

      Trial Summary

      The purpose of this study is to evaluate the safety and tolerability of subcutaneous (SC) cevostamab, including estimation of the maximum tolerated dose (MTD), characterization of dose-limiting toxicity (DLTs), and to identify the recommended phase II dose (RP2D) of SC cevostamab in participants with relapsed or refractory multiple myeloma (R/R MM)

      F. Hoffmann-La Roche (Switzerland) Sponsor
      GO43227 Trial Identifier
      Cevostamab Treatments
      Multiple myeloma Condition
      Official Title

      An open-label, multicenter, Phase Ib trial evaluating the safety, pharmacokinetics, and activity of subcutaneous cevostamab (BFCR4350A) in patients with relapsed or refractory multiple myeloma

      Eligibility Criteria

      Both Gender
      ≥18 Years Age
      No Healthy Volunteers

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