NCT03761108 · Regeneron Pharmaceuticals
Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma
(LINKER-MM1)
What this study is about
The main purpose of this study is to learn about the safety of linvoseltamab and to find out what is the best dose of linvoseltamab to give to patients with multiple myeloma and to look for any signs that linvoseltamab can effectively treat cancer.
View original scientific description
The main purpose of this study is to learn about the safety of linvoseltamab and to find out what is the best dose of linvoseltamab to give to patients with multiple myeloma and to look for any signs that linvoseltamab can effectively treat cancer.
Interventions
DRUG
Linvoseltamab
Administered per the protocol
Primary outcome measures
Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period
Time frame: Up to 28 days
Phase 1 and Phase 2 for Japanese cohort only
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame: Up to 5 years
Phase 1
Incidence and severity of adverse events of special interest (AESI)
Time frame: Up to 5 years
Phase 1
Assessment of the pharmacokinetics (PK) of linvoseltamab
Time frame: Up to 5 years
Phase 1 part 2
Concentrations of linvoseltamab in serum over time
Time frame: Up to 5 years
Phase 2, for Japanese cohort only
Objective response rate (ORR) as determined by an Independent Review Committee (IRC)
Time frame: Up to 5 years
Phase 2, cohorts 1 and 2
Incidence and severity of cytokine release syndrome (CRS) with linvoseltamab
Time frame: Up to 5 years
Phase 2, cohort 3
ORR of IV linvoseltamab as assessed by investigator
Time frame: Up to 5 years
Phase 2, cohort 3
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 2. Confirmed diagnosis of active Multiple Myeloma (MM) by International Myeloma Working Group (IMWG) diagnostic criteria 3. Patients must have myeloma that is response-evaluable according to the 2016 IMWG response criteria as defined in the protocol.
- Phase 1, Part 1 (Dose Escalation): Patients with MM who have exhausted all therapeutic options that are expected to provide meaningful clinical benefit, either through disease relapse, treatment refractory disease or intolerance of the therapy and including either: a. Progression on or after at least 3 lines of therapy, or intolerance of therapy, including a proteasome inhibitor, an Immunomodulatory agent (IMiD), and an anti-CD38 antibody, OR b. Progression on or after an anti-CD38 antibody and have disease that is "double refractory" to a proteasome inhibitor and an IMiD, or intolerance of therapy. The anti-CD38 antibody may have been
Where
- Miami, Florida
- Tampa, Florida
- Atlanta, Georgia
- Indianapolis, Indiana
- Louisville, Kentucky
- Ann Arbor, Michigan
- Detroit, Michigan
- New Brunswick, New Jersey
- New York, New York
- Columbus, Ohio
- Portland, Oregon
- Houston, Texas
And 1 more location — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 20, 2026 · Source of record for eligibility and locations