Clinical trial NCT05927571: A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)
Official title: An Open-Label, Multicenter, Phase Ib Trial Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Patients With Relapsed or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Relapsed or Refractory Multiple Myeloma
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2023-07-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate safety and tolerability of the combination of cevostamab plus elranatamab and also determine the recommended Phase II dose (RP2D) for the study treatment. The study consists of a safety lead-in stage, and an expansion stage.


Eligibility criteria: Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Diagnosis of R/R MM per IMWG criteria
* For female participants of childbearing potential: agreement to remain abstinent or use contraception
* For male participants: agreement to remain abstinent or use a condom

Exclusion Criteria:

* Prior treatment with cevostamab or another agent targeting fragment crystallizable receptor-like 5 (FcRH5)
* Prior treatment with elranatamab
* Prior allogeneic stem cell transplantation (SCT)
* Absolute plasma cell count exceeding 500 per milliliter (mL) or 5% of the peripheral blood white cells
* Diagnosis of Waldenström macroglobulinemia or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, skin changes (POEMS) syndrome
* Participants with known history of amyloidosis
* History of autoimmune disease
* History of confirmed progressive multifocal leukoencephalopathy
* Peripheral motor polyneuropathy of prespecified grade
* Known or suspected chronic cytomegalovirus (CMV) and/or Epstein-Barr virus (EBV) infection
* Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
* Acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
* Human immunodeficiency virus (HIV) seropositivity
* History of central nervous system (CNS) myeloma disease
* Significant cardiovascular disease

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From signing of informed consent up to end of study (EOS) (approximately 36 months)
Secondary outcomes:
measure: Objective Response Rate (ORR) as Determined by the Investigator per International Myeloma Working Group (IMWG) Criteria
timeFrame: Up to approximately 36 months
measure: Complete Response (CR)/ Stringent Complete Response (sCR) Rate as Determined by the Investigator per IMWG Criteria
timeFrame: Up to approximately 36 months
measure: Rate of Very Good Partial Response (VGPR) or Better, as Determined by the Investigator per IMWG Criteria
timeFrame: Up to approximately 36 months
measure: Progression-Free Survival as Determined by the Investigator per IMWG Criteria
timeFrame: Up to approximately 36 months
measure: Duration of Response (DOR) as Determined by the Investigator (for Participants who Achieve a Response of Partial Response (PR) or Better)
timeFrame: Up to approximately 36 months
measure: Time to First Response (for Participants who Achieve a Response of PR or Better)
timeFrame: Up to approximately 36 months
measure: Time to Best Response (for Participants who Achieve a Response of PR or Better)
timeFrame: Up to approximately 36 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 36 months
measure: Serum Concentration of Cevostamab at Specified Timepoints
timeFrame: Up to approximately 36 months
measure: Serum Concentration of Elranatamab at Specified Timepoints
timeFrame: Up to approximately 36 months
measure: Number of Participants with Anti-Drug Antibody (ADA) Against Cevostamab
timeFrame: Up to approximately 36 months
measure: Number of Participants with ADA Against Elranatamab
timeFrame: Up to approximately 36 months
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Prahan
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Ramat-Gan
country: Israel
facility: Sheba Medical Center - PPDS
city: Tel Aviv-Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Center PPDS
city: Seocho
country: Korea, Republic of
facility: The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center - PPDS
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: