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A clinical trial to look at the safety and effectiveness of cevostamab in combination with lenalidomide in people with high-risk multiple myeloma receiving maintenance after transplant
A Study Evaluating the Safety and Efficacy of Multiple Treatment Combinations in Participants With Multiple Myeloma
- Multiple Myeloma
Trial Status:
Recruiting
This trial runs in
Countries
- Poland
- Spain
Trial Identifier:
NCT05583617 2021-005918-34 CO43923
Trial Summary
CO43923 is a platform study that will evaluate the safety, efficacy, and pharmacokinetics (PK) of multiple treatment combinations in subsets of patients with multiple myeloma (MM). The study is designed with the flexibility to open new treatment substudies as new treatments become available. Information regarding the substudy opened is found below.
Hoffmann-La Roche
Sponsor
Phase 1/Phase 2
Phase
NCT05583617 , CO43923 , 2021-005918-34
Trial Identifier
All
Gender
≥18 Years
Age
No
Healthy Volunteers
Why is the CO43923 clinical trial needed?
Multiple myeloma (MM) is a type of bone marrow cancer. A drug called lenalidomide works well in people with less aggressive (low/intermediate risk) MM when used after a stem cell transplant, known as ‘maintenance’ treatment. However, new maintenance treatments are needed for people who have been diagnosed with an aggressive (high-risk) form of MM.
Researchers hope that using lenalidomide in combination with drugs designed to help a person’s own immune system target and destroy cancer cells, like cevostamab, will provide better health outcomes for people with high-risk MM after a transplant.
How does the CO43923 clinical trial work?
This clinical trial is recruiting people who have a health condition called MM. People can take part if they have been diagnosed with high-risk MM that has previously responded to treatment and have received a transplant.
The purpose of this clinical trial is to test the safety and effectiveness of cevostamab in combination with lenalidomide and how the body processes these drugs.
Participants will be given the clinical trial treatment cevostamab in a hospital at different intervals throughout the trial for 13 treatment periods (also known as “cycles”), with each cycle lasting 28 days. Participants will also be given lenalidomide daily for 21 days in 28-day cycles until their disease worsens or until they stop treatment due to side effects.
Participants will be seen by the clinical trial doctor at different intervals throughout the clinical trial. These hospital visits will include checks to see how the participant is responding to the treatment and any side effects they may be having. After their final dose, participants will be seen by the clinical trial doctor around every 3 months at the hospital or by telephone for as long as they agree. Participants’ total time in the clinical trial will be roughly 3‒5 years. Participants are free to stop trial treatment and leave the clinical trial at any time.
What are the main endpoints of the CO43923 clinical trial?
The main clinical trial endpoint (the main results that are measured in the trial to see if the medicine has worked) is: to evaluate the safety of cevostamab in combination with lenalidomide, as measured by the number and type of side effects that participants experience.
The other clinical trial endpoints include the percentage of participants who have either no detectable cancer or who have cancer that has reduced in size by at least 50% compared with the beginning of the trial (objective response rate), and how long participants live (overall survival).
Who can take part in this clinical trial?
People can take part in this trial if they are at least 18 years old, have been diagnosed with high-risk MM, have previously received a transplant within the past 100 days and have not yet started maintenance treatment.
People may not be able to take part in this trial if they have received previous treatment with cevostamab, have certain other medical conditions, have previously received certain treatments, are pregnant or breastfeeding, or are planning to become pregnant.
What treatment 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 clinical trial drug is being used. Everyone who joins this clinical trial will be given cevostamab in combination with lenalidomide in 28-day cycles, followed by lenalidomide alone in 28-day cycles:
- In Cycle 1, participants will be given step-up (or increasing) doses of cevostamab as an infusion into the vein on Day 1, Day 8, and Day 15 (recommended target dose reached on Day 15)
- From Cycles 2‒6, participants will be given cevostamab as an infusion into the vein on Day 1 and Day 15 at the target dose, and then once every 28 days from Cycles 7‒13
- From Cycles 1–13 and onwards, participants will be given lenalidomide as a capsule to be swallowed once a day on Days 1‒21 of each 28-day cycle
Step-up dosing aims to prevent and/or reduce side effects. If a participant experiences a 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 drug called tocilizumab.
Are there any risks or benefits in taking part in this clinical trial?
The safety or effectiveness of the experimental treatment or 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, tocilizumab and lenalidomide
Potential participants will be told about the known side effects of cevostamab, tocilizumab and lenalidomide, and where relevant, also potential side effects based on human and laboratory studies or knowledge of similar drugs.
Cevostamab and tocilizumab will be given by intravenous infusion (into a vein). Participants will be told about any known side effects of intravenous administration.
Lenalidomide will be given as an oral capsule (to be swallowed). Participants will be told about any know side effects of oral administration.
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.
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For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow this link to ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT05583617
Trial Summary
CO43923 is a platform study that will evaluate the safety, efficacy, and pharmacokinetics (PK) of multiple treatment combinations in subsets of patients with multiple myeloma (MM). The study is designed with the flexibility to open new treatment substudies as new treatments become available. Information regarding the substudy opened is found below.
Hoffmann-La Roche
Sponsor
Phase 1/Phase 2
Phase
NCT05583617 , CO43923 , 2021-005918-34
Trial Identifier
Cevostamab, Lenalidomide, Tocilizumab
Treatments
Multiple Myeloma
Condition
Official Title
A Platform Study Evaluating the Safety and Efficacy of Multiple Treatment Combinations in Patients With Multiple Myeloma
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Diagnosed with MM per International Myeloma Working Group (IMWG) criteria
- Eastern Cooperative Oncology Group Performance Status of 0, or 1, or 2
- Resolution of AEs from prior anti-cancer therapy to Grade <=1
- Agreement to undergo scheduled assessments and procedures
Additional Inclusion Criteria for Substudy 2:
- Completion of planned induction therapy and achievement of at least a partial response (PR)
- Autologous Stem Cell Transplant (ASCT) within 100 days prior to first study treatment and the absence of progressive disease
- Cytogenetic high-risk features at diagnosis
- Treatment with any investigational medicinal products, systemic cancer therapies, immunotherapies received previously in CO43923 (any arms) within 5 half-lives or 3 weeks whichever is the shortest
- Agreement to comply with all local requirements of the lenalidomide risk minimization plan, which includes the global pregnancy prevention program
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom even if they have had a prior vasectomy, and agreement to refrain from donating sperm
Exclusion Criteria
- Inability to comply with protocol-mandated hospitalization and procedures
- History of confirmed progressive multifocal leukoencephalopathy
- History of other malignancy within 2 years prior to screening
- Current or past history of central nervous system (CNS) disease
- Significant cardiovascular disease that may limit a participant's ability to adequately respond to a CRS event
- Symptomatic active pulmonary disease or requiring supplemental oxygen
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment, or any major episode of infection requiring treatment with IV antibiotics where the last dose of IV antibiotics was given within 14 days prior to first study treatment
- Known or suspected chronic active Epstein-Barr virus (EBV) infection
- Positive serologic or PCR test results for acute or chronic hepatitis B virus (HBV) infection
- Acute or chronic hepatitis C virus (HCV) infection
- Known history of HIV seropositivity
- Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation that such a live, attenuated vaccine will be required during the study
- Any medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results
Additional Exclusion Criteria for Substudy 2:
- Severe hypersensitivity reactions to lenalidomide
- History of autoimmune disease
- Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
- Harbor lesions at proximity of vital organs that may develop sudden decompensation/deterioration in the setting of a tumor flare
- Chronic treatment with more than 10 milligrams (mg)/day of corticosteroids. The maximal authorized dose of corticosteroids in the study is 10 mg/day when not used to treat an AE or as a premedication for cevostamab dosing
- History of erythema multiforme, Grade >=3 rash, or blistering following prior treatment with immunomodulatory derivatives
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study treatment
For the latest version of this information please go to www.forpatients.roche.com