Trial Title:
A Proof-of-Concept Trial to Study the Safety and Activity of Linvoseltamab in Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma
NCT ID:
NCT05955508
Condition:
Smoldering Multiple Myeloma (SMM)
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Smoldering Multiple Myeloma
Conditions: Keywords:
Linvoseltamab
Multiple Myeloma (MM)
B cell maturation antigen (BCMA)
Bispecific antibody
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Linvoseltamab
Description:
Administration by intravenous (IV) infusion
Arm group label:
Expansion (Part 2)
Arm group label:
Safety Run-In (Part 1)
Other name:
REGN5458
Summary:
This study is researching an investigational drug called linvoseltamab ("study drug") in
participants at high risk of developing multiple myeloma (MM), a group commonly labeled
as high-risk smoldering multiple myeloma (HR-SMM).
The aim of the study is to understand the safety and tolerability (how your body reacts
to linvoseltamab) as well as the effectiveness (how well linvoseltamab eliminates plasma
cells and prevents the development of MM) of the study drug. There are 2 parts to the
study.
- In Part 1, linvoseltamab will be given to a small number of participants to study
the early side effects (safety) of the study drug and make sure the treatment is
acceptable.
- In Part 2, linvoseltamab will be given to more participants to continue to assess
the side effects of the study drug and to evaluate the ability of linvoseltamab to
treat HR-SMM and prevent progression to MM.
The study is looking at several other research questions, including:
- How many participants treated with linvoseltamab (study drug) have improvement of
their HR-SMM?
- What side effects may happen from taking the study drug?
- How much study drug is in your blood at different times?
- Whether the body makes antibodies against the study drug (which could make the drug
less effective or could lead to side effects)
Criteria for eligibility:
Criteria:
KEY Inclusion Criteria:
1. High-risk SMM diagnosis within 5 years of study enrollment
2. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
3. Adequate hematologic and hepatic function, as described in the protocol
4. Estimated glomerular filtration rate ≥30 mL/min/1.73 m^2
KEY Exclusion Criteria:
1. Evidence of myeloma defining events *SLiM CRAB, as described in the protocol
*SLiM (greater than or equal to Sixty percent clonal plasma cells in the bone
marrow, involved/uninvolved free Light chain ratio of ≥100 with the involved free
light chain (FLC) being ≥100 mg/L, MRI with >1 focal lesion) CRAB (hyperCalcemia,
Renal insufficiency, Anemia, or lytic Bone lesions)
2. Diagnosis of systemic light chain amyloidosis, Waldenström macroglobulinemia
(lymphoplasmacytic lymphoma), soft tissue plasmacytoma, or symptomatic multiple
myeloma
3. Clinically significant cardiac or vascular disease within 3 months of study
enrollment, as described in the protocol
4. Any infection requiring hospitalization or treatment with IV anti-infectives within
28 days of first dose of study drug
5. Uncontrolled human immunodeficiency virus (HIV), hepatitis B virus (HBV), or
hepatitis C virus (HCV) infection; or other uncontrolled infection or unexplained
signs of infection
6. History of severe allergic reaction attributed to compounds with a similar chemical
or biologic composition as the study drug or excipient
NOTE: Other protocol defined inclusion/exclusion criteria apply
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Clinico Universitario Santiago de Compostela
Address:
City:
Santiago de Compostela
Zip:
15706
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen de las Nieves
Address:
City:
Granada
Zip:
18014
Country:
Spain
Status:
Recruiting
Facility:
Name:
University Hospital of Cabuenes
Address:
City:
Gijon
Zip:
33203
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitari Son Llatzer
Address:
City:
Palma Mallorca
Zip:
07198
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Germans Trias i Pujol
Address:
City:
Badalona
Zip:
08916
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Marques de Valdecilla
Address:
City:
Santander
Zip:
39008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Quiron Salud Madrid
Address:
City:
Pozuelo de Alarcón
Zip:
28223
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Clinico Universitario Virgen De La Arrixaca
Address:
City:
El Palmar
Zip:
30120
Country:
Spain
Status:
Recruiting
Facility:
Name:
Clinica Universidad de Navarra - Paploma
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Institut Catala d'Oncologia
Address:
City:
Barcelona
Zip:
08908
Country:
Spain
Status:
Recruiting
Facility:
Name:
Clinica Universidad de Navarra - Madrid
Address:
City:
Madrid
Zip:
28027
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Ramon y Cajal
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario de Salamanca
Address:
City:
Salamanca
Zip:
37007
Country:
Spain
Status:
Recruiting
Facility:
Name:
University Hospital Doctor Peset
Address:
City:
Valencia
Zip:
46017
Country:
Spain
Status:
Recruiting
Facility:
Name:
University Hospital La Fe
Address:
City:
Valencia
Zip:
46026
Country:
Spain
Status:
Recruiting
Start date:
January 30, 2024
Completion date:
December 19, 2032
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/NCT05955508
