BridgeMD
A proof-of-concept study to learn whether linvoseltamab can eliminate abnormal plasma cells that may lead to multiple myeloma in adult patients with High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma
EU CTIS ID: 2023-505242-25-00
What this study is testing
Safety Run-In (Part 1): To evaluate the safety and tolerability of linvoseltamab in ascending dose-level cohorts and select the highest dose level for investigation in the expansion part. Expansion (Part 2): To evaluate the ability of linvoseltamab to induce complete responses (CR) by dosing regimen.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- HR-MGUS or NHR-SMM as defined in the protocol
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Adequate hematologic and hepatic function, as described in the protocol
- Estimated glomerular filtration rate (GFR) ≥30 mL/min/1.73 m2 by the modification of diet in renal disease (MDRD) equation.
- NOTE: Other protocol defined inclusion criteria apply
You likely can't join if
- High-risk SMM according to risk stratification models as defined in the protocol.
- Evidence of any of myeloma-defining events, as described in the protocol
- Diagnosis of systemic light-chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), solitary plasmacytoma, or symptomatic MM
- Clinically significant cardiac or vascular disease within 3 months of study enrollment, as described in the protocol
- Any infection requiring hospitalization or treatment with IV anti-infectives within 28 days of the first dose of linvoseltamab
- Uncontrolled human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection; or other uncontrolled infection or unexplained signs of infection.
See the full eligibility criteria
- HR-MGUS or NHR-SMM as defined in the protocol
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Adequate hematologic and hepatic function, as described in the protocol
- Estimated glomerular filtration rate (GFR) ≥30 mL/min/1.73 m2 by the modification of diet in renal disease (MDRD) equation.
- NOTE: Other protocol defined inclusion criteria apply
- High-risk SMM according to risk stratification models as defined in the protocol.
- Evidence of any of myeloma-defining events, as described in the protocol
- Diagnosis of systemic light-chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), solitary plasmacytoma, or symptomatic MM
- Clinically significant cardiac or vascular disease within 3 months of study enrollment, as described in the protocol
- Any infection requiring hospitalization or treatment with IV anti-infectives within 28 days of the first dose of linvoseltamab
- Uncontrolled human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection; or other uncontrolled infection or unexplained signs of infection.
- NOTE: Other protocol defined exclusion criteria apply
The study team makes the final eligibility decision.
Where it's taking place
- United States
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. 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 EU CTIS; the study team decides eligibility.