Trial Title:
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
NCT ID:
NCT05828511
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
Newly diagnosed multiple myeloma (NDMM)
Autologous stem cell transplantation (ASCT)
Cluster of differentiation 3 (CD3)
BCMA
High dose chemotherapy (HDT)
International Myeloma Working Group (IMWG)
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
Note: Phase 1 part B will be randomized 1:1. All other participants will be
non-randomized.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Linvoseltamab
Description:
Linvoseltamab will be administered by intravenous (IV) infusion
Arm group label:
Phase 1 cohort
Arm group label:
Phase 2 - transplant eligible cohort
Arm group label:
Phase 2 - transplant ineligible cohort
Other name:
REGN5458
Summary:
This study is researching an experimental drug called linvoseltamab (called "study
drug"). The study is focused on participants with newly diagnosed multiple myeloma (NDMM)
who are eligible for high dose chemotherapy with autologous stem cell transplantation
(transplant-eligible) or ineligible for autologous stem cell transplantation
(transplant-ineligible).
The aim of this clinical trial is to study the safety, tolerability (how the body reacts
to the drug), and effectiveness (tumor shrinkage) of linvoseltamab in study participants
with NDMM as a first step in determining if the study drug has a role in the treatment of
NDMM.
This study consists of 2 phases:
- In Phase 1, the study drug will be given to participants to study the side effects
of the study drug and to establish the regimen (initial doses and full dose) of the
study drug to be given to participants in Phase 2.
- In Phase 2, the study drug will be given to more participants to continue to assess
the side effects of the study drug and to evaluate the ability of the study drug to
shrink the tumor (multiple myeloma) in participants with NDMM.
The study is looking at several research questions, including:
- What side effects may happen from taking linvoseltamab?
- What the right dosing regimen is for linvoseltamab?
- How many participants treated with linvoseltamab have improvement of their disease
and for how long?
- The effects of linvoseltamab study treatment before and after transplant
- How much linvoseltamab is in the blood at different times?
- Whether the body makes antibodies against linvoseltamab (which could make the drug
less effective or could lead to side effects).
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
1. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
2. Confirmed diagnosis of symptomatic multiple myeloma (MM) by International Myeloma
Working Group (IMWG) diagnosis criteria
3. Measurable disease, according to the 2016 IMWG response criteria, as defined in the
protocol
4. No prior therapy for MM, with the exception of prior emergent or palliative
radiation and up to 1 month of single-agent corticosteroids, with washout periods as
per the protocol
5. Participants must have evidence of adequate bone marrow reserves and hepatic, renal
and cardiac function as defined in the protocol
6. Participants must be age <70 and have adequate hepatic, renal, pulmonary and cardiac
function to be considered transplant-eligible. The specific thresholds for adequate
organ function are as per institutional guidance.
Key Exclusion Criteria:
1. Receiving any concurrent investigational agent with known or suspected activity
against MM, or agents targeting the A proliferation-inducing ligand (APRIL)/
Transmembrane activator and calcium modulator and cyclophilin ligand interactor
(TACI)/BCMA axis
2. Known central nervous system (CNS) involvement with MM, known or suspected
progressive multifocal leukoencephalopathy (PML), a history of neurocognitive
conditions, or CNS movement disorder, or history of seizure within 12 months prior
to study enrollment
3. Rapidly progressive symptomatic disease, (e.g. progressing renal failure or
hypercalcemia not responsive to standard medical interventions), in urgent need of
treatment with chemotherapy
4. Diagnosis of non-secretory MM, active plasma cell leukemia, primary light-chain (AL)
amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or known
POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly,
endocrinopathy, monoclonal protein, and skin changes)
Note: Other protocol-defined Inclusion/Exclusion criteria apply
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Facility:
Name:
UCI Health
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Facility:
Name:
Colorado Blood Cancer Instiute/SCRI
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Facility:
Name:
Norton Cancer Institute
Address:
City:
Louisville
Zip:
40207
Country:
United States
Status:
Recruiting
Facility:
Name:
Karmanos Cancer Institute
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Facility:
Name:
Rutgers Cancer Institute of New Jersey
Address:
City:
New Brunswick
Zip:
08901
Country:
United States
Status:
Recruiting
Facility:
Name:
Perlmutter Cancer Center
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Facility:
Name:
Columbia University Medical Center
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Facility:
Name:
Stony Brook University Hospital
Address:
City:
Stony Brook
Zip:
11794
Country:
United States
Status:
Recruiting
Facility:
Name:
Atrium Health Levine Cancer
Address:
City:
Charlotte
Zip:
28204
Country:
United States
Status:
Recruiting
Facility:
Name:
MD Anderson Cancer Centre
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
CHU De Lille
Address:
City:
Lille
Zip:
59000
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Hopital Pitié Salpetriere APHP
Address:
City:
Paris
Zip:
75013
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital Universitaire Necker Enfants Malades
Address:
City:
Paris
Zip:
75015
Country:
France
Status:
Recruiting
Facility:
Name:
Hospital Saint-Louis - APHP
Address:
City:
Paris
Zip:
75010
Country:
France
Status:
Recruiting
Facility:
Name:
Hospital Germans Trias i Pujol
Address:
City:
Badalona
Zip:
08916
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital General Universitario Doctor Balmis Alicante
Address:
City:
Alicante
Zip:
03010
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Politecnico La Fe
Address:
City:
Valencia
Zip:
46026
Country:
Spain
Status:
Recruiting
Facility:
Name:
Clinica Universidad de Navarra - Madrid
Address:
City:
Madrid
Zip:
28027
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Quironsalud Madrid
Address:
City:
Madrid
Zip:
28223
Country:
Spain
Status:
Recruiting
Facility:
Name:
Clinica Universidad de Navarra
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario de Salamanca
Address:
City:
Salamanca
Zip:
37007
Country:
Spain
Status:
Recruiting
Start date:
December 19, 2023
Completion date:
November 2, 2035
Lead sponsor:
Agency:
Regeneron Pharmaceuticals
Agency class:
Industry
Source:
Regeneron Pharmaceuticals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05828511
