Phase 2 Myeloma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with multiple myeloma (MM) according to recognised international diagnostic standards
• People whose general health and ability to carry out daily activities falls within an acceptable range on a standard medical scale (scores 0, 1, or 2 out of 4) (confirm with trial site)
• People whose side effects from any previous cancer treatment have largely resolved to a mild level or better
• People who are willing and able to attend scheduled check-ups and complete required procedures

For one part of the trial (SS2) only, additional criteria apply:

• People who have completed a planned initial course of treatment and whose myeloma has responded at least partially to that treatment
• People who have had a stem cell transplant using their own stem cells within the 100 days before starting the study, and whose myeloma has not gotten worse since then
• People whose myeloma was identified at diagnosis as having certain high-risk genetic features
• People who have previously taken part in a related study (CO43923) and whose last treatment from that study was received far enough in the past (based on a specific time calculation)
• People who are willing to follow all local safety requirements related to a medication called lenalidomide, including a pregnancy prevention program
• People who can be abstinent from heterosexual intercourse or who are willing to use contraception throughout the study (for people of childbearing potential)
• People who can be abstinent from heterosexual intercourse or who are willing to use a condom (even after a vasectomy), and who agree not to donate sperm during the study (for male participants)

For another part of the trial (SS4) only, an additional criterion applies:

• People with relapsed or treatment-resistant multiple myeloma who have previously been treated with at least three specific types of therapy (a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody), and for whom no suitable standard treatment options remain available

Who may not be able to join:

• People who are unable to follow the study's required hospital visits and procedures
• People with a history of a serious brain condition called progressive multifocal leukoencephalopathy
• People who have had another type of cancer within the past two years
• People with a current or past history of disease affecting the brain or spinal cord
• People with significant heart conditions that could affect how safely the body responds to a potential treatment side effect called cytokine release syndrome (CRS)
• People with active lung disease causing symptoms, or who currently need supplemental oxygen
• People with a known active infection (bacterial, viral, fungal, or other) at the time of enrolling, or who recently needed intravenous (IV) antibiotics within 14 days before starting the study treatment
• People with a known or suspected long-term active Epstein-Barr virus (EBV) infection
• People with blood test results showing a current or past hepatitis B virus infection
• People with a current or past hepatitis C virus infection
• People with a known history of HIV infection
• People who have received a live vaccine within 4 weeks before starting study treatment, or who may need one during the study
• People with any other medical condition or abnormal test result that, in the treating doctor's judgement, would make participation unsafe or affect the reliability of the study results

For SS2 only, additional exclusion criteria apply:

• People who have had a serious allergic reaction to lenalidomide or similar immunomodulatory medications
• People who have tumour lesions located near vital organs that could suddenly worsen if the tumour were to temporarily flare in response to treatment
• People who received treatment in any arm of a related study (CO43923) within a specific recent time period
• People with a known active infection at the time of enrolment, or who recently needed IV antimicrobials within 14 days before starting study treatment
• People with a history of a serious skin reaction (such as erythema multiforme, a severe rash of grade 3 or higher, or blistering) from previous use of immunomodulatory drugs
• People who are pregnant, breastfeeding, or planning to become pregnant during the study or within 5 months after the final dose of study treatment

For both SS2 and SS4, additional exclusion criteria apply:

• People with a history of autoimmune disease
• People with a known history of a serious immune system overreaction condition called haemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
• People who have previously had a severe allergic or anaphylactic reaction to a monoclonal antibody therapy or a related type of biological medicine
• People who have received a high cumulative dose of steroid medication (equivalent to 140 mg or more of prednisone) in the 14 days before the first study dose, not counting pre-treatment medications
• People with an active symptomatic COVID-19 infection at the time of enrolment, or who recently required IV antiviral treatment within 14 days before starting the study — people with active COVID-19 must have recovered and returned two negative antigen tests (at least 24 hours apart) before starting
• People with a detectable and measurable level of Epstein-Barr virus (EBV) or cytomegalovirus (CMV) in the blood before starting study treatment

For SS4 only, additional exclusion criteria apply:

• People who have received investigational treatments, systemic cancer therapies, or immunotherapies within a recent period before the study start (based on a specific time calculation)
• People with a history of severe allergic reaction, including a serious rash (grade 3 or higher), to specific medications including IMiDs, dexamethasone, CELMoDs, or the inactive ingredients in those medicines
• People with known serious allergies, hypersensitivities, or intolerances to a range of substances used in the study treatments, including boron, mannitol, hyaluronidase, sorbitol, corticosteroids, monoclonal antibodies, or human proteins (confirm with trial site)
• People currently taking strong medications that significantly affect how the body breaks down certain drugs (called strong CYP3A modulators), or who have taken proton-pump inhibitors within 2 weeks of starting the study
• People with uncontrolled high blood pressure or uncontrolled diabetes within 14 days before enrolment
• People taking other medications that strongly affect a liver enzyme system called CYP3A4/5, including within 14 days of starting the study
• People with a history of a cancer other than multiple myeloma, unless they have been free of that cancer for 5 or more years
• People with significant nerve damage in the hands or feet (peripheral neuropathy above grade 2)
• People who have previously been treated with a drug called cevostamab, any other drug targeting the same protein (FcRH5), or a drug called iberdomide
• People who are pregnant, breastfeeding, or planning to become pregnant during the study or within 5 months after the final dose of study treatment
• People with a history of Stevens-Johnson syndrome, toxic epidermal necrolysis, or a drug reaction causing a rash with internal organ involvement
• People currently taking systemic (whole-body) immunosuppressant medications
• People who have received CAR T-cell therapy within 12 weeks before the study start phase
• People who have had a stem cell transplant using their own stem cells within 100 days before the study start phase
• People who have previously had a stem cell transplant using another person's cells (allogeneic SCT)
• People who have tumour masses (plasmacytomas) located near vital organs that could suddenly worsen if the tumour were to temporarily flare in response to treatment

Important: Always verify eligibility with the trial site directly before applying.