NCT05828511 · Regeneron Pharmaceuticals
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
(LINKER-MM4)
What this study is about
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).
View original scientific description
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).
Interventions
DRUG
Linvoseltamab
Linvoseltamab will be administered by intravenous (IV) infusion
Primary outcome measures
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: End of the Observation period; up to day 28
Phase 1
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Post-Last Linvoseltamab Dose, up to 90 days
Phase 1
Severity of TEAEs
Time frame: Post-Last Linvoseltamab Dose, up to 90 days
Phase 1
Incidence of Adverse Events of Special Interest (AESIs)
Time frame: Post-Last Linvoseltamab Dose, up to 90 days
Phase 1
Severity of AESIs
Time frame: Post-Last Linvoseltamab Dose, up to 90 days
Phase 1
Proportion of participants with a Very Good Partial Response (VGPR) or better using the International Myeloma Working Group (IMWG) response criteria
Time frame: Up to 5 years
Phase 2
Proportion of participants achieving Minimal Residual Disease (MRD) negative status (at 10^-5) after induction with consolidation therapy
Time frame: Up to 5 years
Phase 2 Transplant-eligible cohort
Proportion of participants achieving MRD-negative status (at 10^-5) after induction without consolidation therapy
Time frame: Up to 5 years
Phase 2 Transplant-eligible cohort
Proportion of participants achieving MRD-negative status as their best response after treatment period I with continuing to treatment period II
Time frame: Up to 5 years
Phase 2 Transplant-ineligible cohort
Proportion of participants achieving MRD-negative status as their best response after treatment period I without continuing to treatment period II
Time frame: Up to 5 years
Phase 2 Transplant ineligible cohort
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 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
- Receiving any concurrent investigational agent with known or suspected activity against MM, or agents target
Where
- Los Angeles, California
- Orange, California
- Denver, Colorado
- Louisville, Kentucky
- Detroit, Michigan
- New Brunswick, New Jersey
- Mineola, New York
- New York, New York
- Stony Brook, New York
- Charlotte, North Carolina
- Durham, North Carolina
- Houston, Texas
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 May 13, 2026 · Source of record for eligibility and locations