To hear about similar clinical trials, please enter your email below
Trial Title:
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)
NCT ID:
NCT05927571
Condition:
Relapsed or Refractory Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cevostamab
Description:
Cevostamab solution for infusion will be administered as IV as specified in each
treatment arm.
Arm group label:
Dose Expansion Cohort
Arm group label:
Safety Lead-In Cohort
Intervention type:
Drug
Intervention name:
Elranatamab
Description:
Elranatamab solution for injection will be administered SC as specified in each treatment
arm.
Arm group label:
Dose Expansion Cohort
Arm group label:
Safety Lead-In Cohort
Intervention type:
Drug
Intervention name:
Tocilizumab
Description:
Tocilizumab will be used as rescue medication for participants who experience a cytokine
release syndrome (CRS) event.
Arm group label:
Dose Expansion Cohort
Arm group label:
Safety Lead-In Cohort
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Alfred Hospital
Address:
City:
Prahan
Zip:
3181
Country:
Australia
Status:
Recruiting
Facility:
Name:
Rambam Health Care Campus
Address:
City:
Haifa
Zip:
3109600
Country:
Israel
Status:
Recruiting
Facility:
Name:
Sheba Medical Center - PPDS
Address:
City:
Ramat Gan
Zip:
5266202
Country:
Israel
Status:
Recruiting
Facility:
Name:
Tel Aviv Sourasky Medical Center PPDS
Address:
City:
Tel Aviv-Yafo
Zip:
6423906
Country:
Israel
Status:
Recruiting
Facility:
Name:
The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)
Address:
City:
Seocho
Zip:
06591
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Samsung Medical Center - PPDS
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Start date:
August 10, 2023
Completion date:
July 31, 2026
Lead sponsor:
Agency:
Genentech, Inc.
Agency class:
Industry
Source:
Genentech, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05927571
