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Compares treatment options for Multiple Myeloma
Official title A Study to Learn How Safe and How Well Linvoseltamab Works Compared to Standard Treatment in Adult Patients With Multiple Myeloma Who Are Not Eligible for Transplant
ClinicalTrials.gov ID: NCT06932562
What this study is testing
What is Linvoseltamab?
Linvoseltamab is an investigational medicine, being studied as a potential treatment for multiple myeloma.
Also referred to as REGN5458.
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. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplantation (transplant-ineligible).
- Phase 3: a large, late-stage study
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
- Participants must have confirmed diagnosis of symptomatic MM per IMWG criteria.
- Participants must not be considered a candidate for high-dose chemotherapy (HDT) and ASCT, as described in the protocol.
- Participants must have measurable disease as defined in the protocol.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Participants must have clinical laboratory values within a prespecified range.
You likely can't join if
- International Myeloma Working Group Frailty Index of 2 with the exception of participants who have a score of 2 based on age alone.
- Participants who defer transplant due to personal preference.
- Participants with non-secretory MM, active plasma cell leukemia, known light-chain (AL) amyloidosis in the presence of a concurrent diagnosis of...
- Any prior therapy for monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), or MM, with the exception of:
- focal radiation and/or
- a short course of corticosteroids as defined in the protocol.
See the full eligibility criteria
- Participants must have confirmed diagnosis of symptomatic MM per IMWG criteria.
- Participants must not be considered a candidate for high-dose chemotherapy (HDT) and ASCT, as described in the protocol.
- Participants must have measurable disease as defined in the protocol.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Participants must have clinical laboratory values within a prespecified range.
- International Myeloma Working Group Frailty Index of 2 with the exception of participants who have a score of 2 based on age alone.
- Participants who defer transplant due to personal preference.
- Participants with non-secretory MM, active plasma cell leukemia, known light-chain (AL) amyloidosis in the presence of a concurrent diagnosis of myeloma, any other form of amyloidosis, Waldenström macroglobulinemia, or...
- Any prior therapy for monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), or MM, with the exception of:
- focal radiation and/or
- a short course of corticosteroids as defined in the protocol.
- Participants who have received or are receiving any investigational agent or cell therapy with known or suspected activity against MM
- Participants who have known central nervous system (CNS) or meningeal involvement with MM or known or suspected progressive multifocal leukoencephalopathy (PML), a history of a neurocognitive condition or CNS movement...
- Participants who have uncontrolled intercurrent illness.
- Known contraindications to the use of daratumumab or lenalidomide per local prescribing information.
- History of allogeneic hematopoietic stem cell transplantation or solid organ transplant at any time. NOTE Other protocol defined inclusion/exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Adelaide, Australia
- Box Hill, Australia
- Canberra, Australia
- Geelong, Australia
- Heidelberg, Australia
- Kingswood, Australia
- Melbourne, Australia
- Sunshine Coast, Australia
- Linz, Austria
- Vienna, Austria
- Zagreb, Croatia
- Hradec Králové, Czechia
- Olomouc, Czechia
- Ostrava, Czechia
- Pilsen, Czechia
- Aarhus, Denmark
- Tallinn, Estonia
- Tartu, Estonia
- Helsinki, Finland
- Kuopio, Finland
+ 35 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 Adelaide, Australia; Box Hill, Australia; Canberra, Australia; Geelong, Australia; Heidelberg, Australia; Kingswood, Australia and 49 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.