Phase
Condition
Multiple Myeloma
Cancer/tumors
Platelet Disorders
Treatment
Cevostamab
RO7296682
Dexamethasone
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 SS2:
Completion of planned induction therapy and achievement of at least a partialresponse (PR)
Autologous Stem Cell Transplant (SCT) within 100 days prior to first study treatmentand 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 3weeks whichever is the shortest
Agreement to comply with all local requirements of the lenalidomide riskminimization plan, which includes the global pregnancy prevention program
For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception
For male participants: agreement to remain abstinent (refrain from heterosexualintercourse) or use a condom even if they have had a prior vasectomy, and agreementto refrain from donating sperm
Additional Inclusion Criteria for SS4:
- Previously exposed to at least a PI, an IMiD, and an anti-CD38 antibody for thetreatment of R/R MM for whom no suitable SOC therapy options are available
Exclusion
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 toadequately respond to a CRS event
Symptomatic active pulmonary disease or requiring supplemental oxygen
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infectionat study enrollment, or any major episode of infection requiring treatment with IVantibiotics where the last dose of IV antibiotics was given within 14 days prior tofirst 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 ofstudy treatment or anticipation that such a live, attenuated vaccine will berequired during the study
Any medical condition or abnormality in clinical laboratory tests that, in theinvestigator's judgment, precludes the participant's safe participation in andcompletion of the study, or which could affect compliance with the protocol orinterpretation of results
Additional Exclusion Criteria for SS2:
Hypersensitivity reactions to lenalidomide or other immunomodulatory drugs
Harbor lesions at proximity of vital organs that may develop suddendecompensation/deterioration in the setting of a tumor flare
Prior treatment with any investigational medicinal product, systemic cancer therapy,or immunotherapies in any arm of study CO43923 within 5 half-lives or 3 weeks,whichever is shorter
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episodeof infection requiring treatment with IV antimicrobials where the last dose of IVantimicrobial was given within 14 days prior to first study treatment
History of erythema multiforme, Grade >=3 rash, or blistering following priortreatment with immunomodulatory derivatives
Pregnant or breastfeeding, or intending to become pregnant during the study orwithin 5 months after the final dose of study treatment Exlcusion CriteriaApplicable to SS2 and SS4
History of autoimmune disease
Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activationsyndrome (MAS)
History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisonewithin the 14-day period before the first dose of the study drug (does not includepretreatment medication)
Active symptomatic COVID-19 infection at study enrollment or requiring treatmentwith IV antiviral where the last dose of IV antiviral treatment was given within 14days prior to first study treatment. Participants with active COVID-19 infectionmust have clinical recovery and two negative antigen tests at least 24 hours apartprior to first study treatment.
Positive and quantifiable EBV PCR or CMV PCR prior to first study treatment
Additional Exclusion Criteria for SS4:
Treatment with any investigational medicinal products, systemic cancer therapies,immunotherapies within 5 half-lives or 12 weeks before starting pre-phase
History of anaphylaxis or hypersensitivity, including >=Grade 3 rash, during priortreatment with IMiDs, dexamethasone, any CELMoDs, or the excipients contained in theformulations
Known anaphylaxis, allergies, hypersensitivity, or intolerance to boron or mannitol,hyaluronidase, sorbitol, corticosteroids, monoclonal antibodies (or recombinantantibody-related fusion proteins), or human proteins, CRBN modulating agents ortheir excipients, or known sensitivity to mammalian-derived products
Administration of strong CYP3A modulators; administration of proton-pump inhibitorswithin 2 weeks of starting study treatment
Uncontrolled hypertension or uncontrolled diabetes within 14 days prior toenrollment
Concurrent administration of a strong inhibitor, modulator or inducer of cytochromeP450 (CYP3A4/5) (including within 14 days of initiating study treatment)
History of malignancies, other than MM, unless the subject has been free of thedisease for >=5 years
Peripheral neuropathy >Grade 2
Prior treatment with cevostamab or another agent targeting FcRH5 or iberdomide
Pregnant or breastfeeding, or intending to become pregnant during the study orwithin 5 months after the final dose of study treatment
History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug rash witheosinophilia and systemic symptoms
Treatment with systemic immunosuppressive medications
Prior treatment with CAR T-cell therapy (autologous or allogeneic) within 12 weeksbefore starting pre-phase
Autologous SCT within 100 days prior to starting pre-phase
Prior allogeneic SCT
Plasmacytoma in proximity of vital organs that may develop suddendecompensation/deterioration in the setting of a tumor flare
Study Design
Study Description
Connect with a study center
Prince of Wales Hospital
Randwick, New South Wales 2031
AustraliaActive - Recruiting
Prince of Wales Hospital; Haematology
Randwick, New South Wales 2031
AustraliaActive - Recruiting
St Vincent's Hospital Melbourne
Fitzroy, Victoria 3065
AustraliaActive - Recruiting
CHU Lyon Sud - Service Hématologie
Pierre Benite, 69310
FranceSite Not Available
Hopital Bretonneau
TOURS Cedex, 37044
FranceActive - Recruiting
Hopital Bretonneau; Hematologie Therapie Cellulaire
TOURS Cedex, 37044
FranceActive - Recruiting
IUCT Oncopole
Toulouse, 31059
FranceActive - Recruiting
IUCT Oncopole; Hematologie
Toulouse, 31059
FranceActive - Recruiting
IGR
Villejuif, 94800
FranceActive - Recruiting
Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II
Hamburg, 20246
GermanyActive - Recruiting
Universitätsklinikum Leipzig - Klinik und Poliklinik für Hämatologie
Leipzig, 04103
GermanyActive - Recruiting
Samsung Medical Center
Seoul, 06351
Korea, Republic ofActive - Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
Korea, Republic ofActive - Recruiting
Uniwersyteckie Centrum Kliniczne
Gda?sk, 80-214
PolandActive - Recruiting
Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii
Gda?sk, 80-214
PolandActive - Recruiting
Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii
Gdansk, 80-952
PolandSite Not Available
Oddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn, 10-228
PolandActive - Recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
Pozna?, 60-569
PolandActive - Recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu; Oddzial Hematologii i Transplantacji Szpiku
Pozna?, 60-569
PolandActive - Recruiting
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona 08915
SpainActive - Recruiting
Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia
Badalona, Barcelona 08915
SpainActive - Recruiting
Fundacion Jimenez Diaz
Madrid, 28040
SpainActive - Recruiting
Fundacion Jimenez Diaz; Servicio de Hematologia
Madrid, 28040
SpainActive - Recruiting
Hospital Clinico Universitario de Valencia
Valencia, 46010
SpainActive - Recruiting
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, 46010
SpainActive - Recruiting
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