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New treatment option for Multiple Myeloma
Official 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
ClinicalTrials.gov ID: NCT05828511
What this study is testing
What is Linvoseltamab?
Linvoseltamab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for multiple myeloma.
Also referred to as REGN5458, Lynozyfic™.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Confirmed diagnosis of symptomatic Multiple Myeloma (MM) by International Myeloma Working Group (IMWG) diagnosis criteria, as described in the...
- Response-evaluable myeloma, according to the 2016 IMWG response criteria, as defined in the protocol
- 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...
- Participants must have evidence of adequate bone marrow reserves and hepatic, renal and cardiac function as defined in the protocol
You likely can't join if
- Receiving any concurrent investigational agent with known or suspected activity against MM, or agents targeting the A proliferation-inducing ligand...
- Known Central Nervous System (CNS) involvement with MM, known or suspected Progressive Multifocal Leukoencephalopathy (PML), a history of...
- Rapidly progressive symptomatic disease, (e.g. progressing renal failure or hypercalcemia not responsive to standard medical interventions), in...
- Diagnosis of non-secretory MM, active plasma cell leukemia primary light-chain (AL) amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic...
See the full eligibility criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Confirmed diagnosis of symptomatic Multiple Myeloma (MM) by International Myeloma Working Group (IMWG) diagnosis criteria, as described in the protocol
- Response-evaluable myeloma, according to the 2016 IMWG response criteria, as defined in the protocol
- 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
- Participants must have evidence of adequate bone marrow reserves and hepatic, renal and cardiac function as defined in the protocol
- 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...
- 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...
- 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...
- Rapidly progressive symptomatic disease, (e.g. progressing renal failure or hypercalcemia not responsive to standard medical interventions), in urgent need of treatment with chemotherapy
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Orange, California, United States
- Denver, Colorado, United States
- Louisville, Kentucky, United States
- Detroit, Michigan, United States
- New Brunswick, New Jersey, United States
- Mineola, New York, United States
- New York, New York, United States
- Stony Brook, New York, United States
- Charlotte, North Carolina, United States
- Durham, North Carolina, United States
- Houston, Texas, United States
- Poitiers, Vienne, France
- Lille, France
- Montpellier, France
- Paris, France
- Antony, Île-de-France Region, France
- Paris, Île-de-France Region, France
- Villejuif, Île-de-France Region, France
- Badalona, Barcelona, Spain
+ 8 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Orange, California, United States; Denver, Colorado, United States; Louisville, Kentucky, United States; Detroit, Michigan, United States; New Brunswick, New Jersey, United States and 22 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.