OncoMatch/Clinical Trials/NCT06376526
IMMUNOPLANT for Newly Diagnosed Multiple Myeloma
Is NCT06376526 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Linvoseltamab for multiple myeloma.
Treatment: Linvoseltamab — The purpose of this study is to determine whether Linvoseltamab therapy in patients with newly diagnosed multiple myeloma will convert the disease status from minimal residual disease (MRD)-positive to MRD-negative, and increase the length of time that the disease is controlled. The researchers also want to find out the effects (good and bad) that Linvoseltamab has on participants and the condition.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: combination therapy containing at least two of: immunomodulatory drug, proteasome inhibitor, anti-CD38 — initial induction
Documentation of having received a triplet or quadruplet based initial combination therapy containing at least two of the following: Immunomodulatory drug (IMiD), proteosome inhibitor (PI), and/or anti-cluster of differentiation 38 (anti-CD38).
Cannot have received: systemic therapies for MM other than initial IMiD/PI/anti-CD38-based combination therapy (high-dose melphalan with autologous stem cell transplant, allogeneic stem cell transplant)
Exception: limited cycles of other induction therapies (e.g., CyBorD or pulse dexamethasone prior to main induction) allowed
Patients who have received prior systemic therapies for MM other than initial IMiD/PI/anti-CD38-based combination therapy (receiving limited cycles of other induction therapies, eg, cyclophosphamide, bortezomib and dexamethasone (CyBorD) or pulse dexamethasone prior to main induction is allowed). Exclusions include high-dose melphalan with autologous stem cell transplant (HDM-ASCT) and allogeneic stem cell transplant (SCT).
Lab requirements
Blood counts
ANC ≥1,000 cells/mcL (unless patient has ethnic/cyclic neutropenia or if neutropenia is thought to be due to MM); Platelets ≥50,000/mcL; Hemoglobin ≥8 g/dL (transfusions permitted)
Kidney function
Serum creatinine ≤ 1.5 X ULN (except if due to myeloma) or eGFR ≥30 mL/min/1.73 m2 (measured GFR can also be used)
Liver function
Serum total bilirubin ≤ 1.5 X ULN or direct bilirubin ≤ ULN for patients with total bilirubin levels > 1.5 ULN (except patients with Gilbert's syndrome who must have a total bilirubin of <3 X ULN); AST and ALT ≤ 2.5 X ULN
Adequate organ function, which is defined as follows: a. Absolute neutrophil count (ANC) ≥1,000 cells/microliter (mcL) (unless patient has ethnic/cyclic neutropenia or if neutropenia is thought to be due to MM) b. Platelets ≥50,000 platelets/mcL c. Hemoglobin ≥8 g/dL (transfusions permitted) d. Serum total bilirubin ≤ 1.5 X upper limit of normal (ULN) or direct bilirubin ≤ ULN for patients with total bilirubin levels > 1.5 ULN (except patients with Gilbert's syndrome who must have a total bilirubin of <3 X ULN) e. Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)) and alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (SGPT)) ≤ 2.5 X ULN f. Serum creatinine ≤ 1.5 X ULN (except if due to myeloma) or estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 (note that measured glomerular filtration rate [GFR], ie, 24-hour urine, can also be used)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Miami · Miami, Florida
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