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Compares treatment options for Relapsed Refractory Multiple Myeloma (RRMM)
Official title A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT05730036
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 relapsed refractory multiple myeloma (rrmm).
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, also called REGN5458. Linvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after many other therapies had failed.
- 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
- Age 18 years or older (or legal adult age in the country) at the time of the screening visit.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1. Patients with ECOG 2 solely due to local symptoms of myeloma (eg. pain) may be...
- Received at least 1 and no more than 4 prior lines of anti-neoplastic MM therapies, including lenalidomide and a proteasome inhibitor and...
- Patients must have measurable disease for response assessment as per the 2016 IMWG response assessment criteria, as described in the protocol
- Adequate hematologic function and hepatic function within 7 days of randomization, as well as adequate renal and cardiac function and corrected...
You likely can't join if
- Diagnosis of plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy...
- Prior treatment with elotuzumab and/or pomalidomide
- Participants with known MM brain lesions or meningeal involvement
- Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28 days before first administration of study drug, whichever is shorter
- History of allogeneic stem cell transplantation within 6 months, or autologous stem cell transplantation within 12 weeks of the start of study...
- Prior treatment with B-cell maturation antigen (BCMA) directed immunotherapies Note: BCMA antibody-drug conjugates are allowed.
See the full eligibility criteria
- Age 18 years or older (or legal adult age in the country) at the time of the screening visit.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1. Patients with ECOG 2 solely due to local symptoms of myeloma (eg. pain) may be allowed after discussion with the Medical Monitor.
- Received at least 1 and no more than 4 prior lines of anti-neoplastic MM therapies, including lenalidomide and a proteasome inhibitor and demonstrated disease progression on or after the last therapy as defined by the...
- Patients must have measurable disease for response assessment as per the 2016 IMWG response assessment criteria, as described in the protocol
- Adequate hematologic function and hepatic function within 7 days of randomization, as well as adequate renal and cardiac function and corrected calcium
- Life expectancy of at least 6 months Key
- Diagnosis of plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
- Prior treatment with elotuzumab and/or pomalidomide
- Participants with known MM brain lesions or meningeal involvement
- Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28 days before first administration of study drug, whichever is shorter
- History of allogeneic stem cell transplantation within 6 months, or autologous stem cell transplantation within 12 weeks of the start of study treatment. Participants who have received an allogeneic transplant must be...
- Prior treatment with B-cell maturation antigen (BCMA) directed immunotherapies Note: BCMA antibody-drug conjugates are allowed.
- History of progressive multifocal leukoencephalopathy (PML), known or suspected PML, or history of a neurocognitive condition or central nervous system (CNS) movement disorder (Parkinson's disease or Parkinsonism).
- Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first administration of study drug
- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); or another uncontrolled infection, as defined in the protocol 10 Cardiac ejection fraction \<40%. NOTE...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Gainesville, Florida, United States
- Lexington, Kentucky, United States
- Louisville, Kentucky, United States
- Stony Brook, New York, United States
- Charlotte, North Carolina, United States
- Durham, North Carolina, United States
- Portland, Oregon, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Camperdown, New South Wales, Australia
- St Leonards, New South Wales, Australia
- Auchenflower, Queensland, Australia
- Herston, Queensland, Australia
- Adelaide, South Australia, Australia
- Hobart, Tasmania, Australia
- Launceston, Tasmania, Australia
- Fitzroy, Victoria, Australia
- Geelong, Victoria, Australia
- Heidelberg, Victoria, Australia
+ 112 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; Gainesville, Florida, United States; Lexington, Kentucky, United States; Louisville, Kentucky, United States; Stony Brook, New York, United States; Charlotte, North Carolina, United States and 126 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.