
Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma (CERVINO)
CODICE STUDIO
NCT06158841
TIPOLOGIA
Ricaduti
NOME SPONSOR
AbbVie
DESCRIZIONE
Trattamento
Experimental: Etentamig
Participants will receive etentamig as a monotherapy. Drug: Etentamig
- Intravenous (IV) Infusion
- Other Names:
- ABBV-383
Experimental: Standard Available Therapy (SAT)
Participants will receive SAT, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. SAT choices are carfilzomib + dexamethasone (Kd), elotuzumab + pomalidomide + dexamethasone (EloPd), selinexor + bortezomib + dexamethasone (SVd). Drug: Carfilzomib
- IV Infusion
Drug: Pomalidomide
- Oral Capsule
Drug: Elotuzumab
- IV Infusion
Drug: Selinexor
- Oral Tablet
Drug: Bortezomib
- Subcutaneous or IV Injection
Drug: Dexamethasone
- Oral Tablet or IV Infusion
Obiettivo primario
- Progression Free Survival (PFS) [ Time Frame: Up to Approximately 5 Years ]
PFS is defined as the duration from the date of randomization to the date of confirmed disease progression (PD) determined by independent review committee (IRC) per international myeloma working group (IMWG) (2016) response criteria, or death, whichever occurs first. 5 Years - Objective Response Rate (ORR) [ Time Frame: Up to Approximately 5 Years ]
ORR is defined as the percentage of participants who achieve confirmed partial response (PR) + VGPR + complete response (CR) + stringent complete response (sCR) or per IRC assessment.
Criteri di inclusione
- Eastern Cooperative Oncology Group (ECOG) performance of <= 2.
- Diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) during or after the participant’s last treatment as stated in the protocol.
- Must have measurable disease with at least 1 of the following assessed within 28 days of enrollment:
- Serum M-protein >= 0.5 g/dL (>= 5 g/L).
- Urine M-protein >= 200 mg/24 hours.
- In participants without measurable serum or urine M protein, serum free light chain (FLC) >= 100 mg/L (10 mg/dL) (involved light chain) and an abnormal serum kappa lambda ratio.
- Must have received at least 2 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide (IMiD), and an anti-CD38 monoclonal antibody (mAb).
- Must be eligible to receive the Investigator’s choice standard available therapy (SAT) based on approved prescribing information, previous MM treatment history, and institutional guidelines.
Criteri di esclusione
- Clinically significant (per Investigator’s judgment) drug or alcohol abuse within the last 6 months.
- Clinically significant conditions such as but not limited to the following: neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months that would adversely affect the participant’s participation in the study.
- Central nervous system involvement of MM.
- Has received B-cell maturation antigen (BCMA)-targeted therapy.
FARMACI UTILIZZATI