The study is researching an experimental drug called linvoseltamab in combination with other drugs for the treatment of a blood cancer called multiple myeloma.
This trial is currently open and accepting patients.
The study is researching an experimental drug called linvoseltamab in combination with other drugs for the treatment of a blood cancer called multiple myeloma. Linvoseltamab has previously been studied as a single agent (without other cancer treatments) in participants with multiple myeloma that returned after multiple prior therapies and needed to be treated again.
In the initial study, some participants treated with linvoseltamab had improvement of their myeloma, including complete responses (no evidence of myeloma in their bodies). This study is the first time linvoseltamab will be combined with other cancer therapies. The main goal is to understand if linvoseltamab can be given safely with other cancer treatments, and if so, what dose of linvoseltamab should be used for each combination.
The study is looking at several other research questions, including:
The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.
General Key Inclusion Criteria:
Cohort Specific Inclusion Criteria:
For cohorts 1-6, each participant must have RRMM with progression following at least 3 lines of therapy, or at least 2 lines of therapy and either prior exposure to at least 1 anti-CD38 antibody, 1 immunomodulatory imide drug (IMiD) and 1 proteasome inhibitor (PI), or double-refractory to 1 PI and 1 IMiD, or the combination of 1 PI and 1 IMiD.
Cohort 1: Prior treatment with daratumumab is allowed if previously tolerated. However, participants enrolled in the expansion portion cannot be refractory to an anti-CD38 antibody containing regimen. In addition, all participants must have at least a 6-month washout from prior anti-CD38 antibody therapy.
Cohort 2: Prior treatment with carfilzomib is allowed if previously tolerated at the approved full dose. Carfilzomib-refractory participants may enroll in the dose finding portion provided they are triple-class refractory (PI, IMiD, anti-CD38 antibody). However, participants enrolled in the dose expansion portion cannot be refractory to carfilzomib. In addition, all participants must have at least a 6-month washout from prior carfilzomib therapy.
Cohort 3: Prior treatment with lenalidomide is allowed if previously tolerated at the approved full dose. However, a participant cannot be refractory to any combination regimen that included 25 mg of lenalidomide. In addition, participants must have at least a 6-month washout from any prior lenalidomide therapy (including maintenance therapy).
Cohort 4: Prior treatment with bortezomib is allowed if previously tolerated at the approved full dose. Bortezomib-refractory participants may enroll in the dose finding portion provided they are triple-class refractory (PI, IMiD, anti-CD38 antibody). However, participants enrolled in the dose expansion portion cannot be refractory to bortezomib. In addition, all participants must have at least a 6-month washout from prior bortezomib therapy.
Cohort 5: Prior treatment with pomalidomide is allowed if previously tolerated at the approved full dose. Additionally, participants must undergo at least a 6-month washout following prior pomalidomide therapy before enrollment.
Cohort 6: Prior treatment with isatuximab is allowed if previously tolerated. Additionally, participants must undergo at least a 3-month washout following prior anti-CD38 antibody therapy before enrollment.
Cohort 7 and 8: RRMM with progressive disease and received at least 3 lines of therapy including exposure to at least 1 anti-CD38 antibody, 1IMiD, and 1 PI or triple-class refractory disease (anti-CD38 antibody, IMiD, PI).
Cohort 9: Progressive RRMM in participants with triple-class refractory disease (anti-CD38 antibody, IMiD, PI) after at least 3 lines of therapy Cohort 10: Progressive RRMM after at least 3 lines of therapy including exposure to at least 1 anti-CD38 antibody, 1 IMiD, and 1 PI.
General Key Exclusion Criteria:
Cohort Specific Exclusion Criteria:
Cohort 2:
1. Dose expansion: Prior treatment with a B-cell maturation antigen (BCMA) -directed CAR T-cell therapy will not be exclusionary if completed at least 12 weeks prior to first study treatment
Cohort 3:
1. Known malabsorption syndrome or pre-existing gastrointestinal (GI) condition that may impair absorption of lenalidomide; delivery of lenalidomide via nasogastric tube or gastrostomy tube is not allowed.
Cohort 4:
1. Peripheral neuropathy grade ≥2
Cohort 5:
1. Known malabsorption syndrome or pre-existing GI conditions that may impair absorption of pomalidomide; delivery of pomalidomide via nasogastric tube or gastrostomy tube is not allowed.
Cohort 7:
Cohort 8:
Cohort 9:
Cohort 10:
NOTE: Other protocol defined inclusion/exclusion criteria apply
Phase 1
Enrollment: 317 patients (estimated)
View MoreJune 01, 2025
As of Sept 30, 2024, 22 pts had received tx (DL1: n=6; DL2: n=16). Median follow-up duration was 6.3 mos (range 1–21), with 55% of pts still receiving tx. Median age was 68.5 yrs (range 45–77), 68% were male, 23% had ISS stage III, and 55% had extramedullary or paraskeletal disease. Median prior LoT was 3 (range 2–9), including 86% of pts with TCE and 41% with triple-class refractory disease; 59% were refractory to ≥1 PI (9% BTZ-refractory).
Among evaluable pts, ORR was 79% (11/14; DL1 80% [4/5]; DL2 78% [7/9]). The 6-month DOR rate was 90% (95% CI 47–99) and 6-month PFS rate was 79% (95% CI 47–93). PK analysis found LINVO concentrations were not affected by addition of BTZ.
The most common TEAEs were neutropenia (any Grade [Gr] 59%; Gr 3–4 45%), thrombocytopenia (50%; 36%), and cytokine release syndrome (55%; 0%). ICANS was reported in 4 pts (all Gr 1–2 with onset during step-up dosing). Infections were reported in 82% of pts (Gr 3–4 36%); 1 pt died of pneumonia ≤30 days after last dose before start of combination tx. One DLT occurred at DL2 (Gr 3 CMV colitis on day 48; resolved with tx delay and ganciclovir).
View all clinical trial locations sorted by state.
New York, NY
Chapel Hill, NC
Winston-Salem, NC
Columbus, OH
Dallas, TX
We know how difficult and confusing this process can be. If you are interested in this clinical trial or have questions, you can call us at any time. You can also send us a direct message with questions.
(888) 828-2206If you are interested in keeping an eye on this trial, you can add it to your list of favorite trials. We'll send you alerts when this trial is updated.
You can explore trial locations from around the US and connect directly with a trial coordinator.
Find Nearby LocationsYou can print an overview of this trial to take in to your next appointment. Your doctor can help you understand if this trial may be right for you.
Still need help? Send us a message