OncoMatch/Clinical Trials/NCT06910124
Linvoseltamab in Addition to Lenalidomide (L2) During Maintenance Therapy of NDMM to Deepen Responses or Redrive MRD Negativity After Relapse
Is NCT06910124 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Linvoseltamab and Lenalidomide for multiple myeloma.
Treatment: Linvoseltamab · Lenalidomide — The purpose of this study is to determine whether giving linvoseltamab with lenalidomide during maintenance treatment to participants with multiple myeloma will: 1. Get rid of any residual multiple myeloma cells in participants' bodies which is known as minimal residual disease negative (MRD-) status. For participants that start the study with residual multiple myeloma cells in participants' bodies: to determine how long you remain MRD-. 2. Increase the length of time that participants' disease is controlled. For participants with relapsed disease, to determine whether participants can re-attain MRD- status. 3. Increase the length of time that participants' disease responds to treatment. The researchers also want to find out the effects that linvoseltamab has on participants and participants' condition.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Must have received: combination therapy containing at least two of: immunomodulatory drug (IMiD), proteasome inhibitor (PI), anti-CD38 — initial therapy
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)
Must have received: induction therapy with or without high-dose melphalan with autologous stem cell transplant (HDM-ASCT) — induction
receiving induction therapy with or without high-dose melphalan with autologous stem cell transplant (HDM-ASCT) and receiving lenalidomide maintenance therapy ≤ 12 months
Must have received: lenalidomide maintenance therapy (lenalidomide) — maintenance
receiving lenalidomide maintenance therapy ≤ 12 months
Cannot have received: systemic therapies for Multiple Myeloma other than initial IMiD/PI/anti CD38/HDM-ASCT-based combination therapy
Exception: corticosteroids, prior radiation therapy and surgery permitted
Patients who have received prior systemic therapies for Multiple Myeloma (MM) other than initial IMiD/PI/anti CD38/HDM-ASCT-based combination therapy
Lab requirements
Blood counts
ANC ≥ 1000/microlitre (unless patient has ethnic neutropenia); Platelets ≥ 50,000/microlitre; Hemoglobin ≥ 8 g/dL (transfusions permitted)
Kidney function
Serum creatinine ≤ 1.5 X ULN (except if due to myeloma) or eGFR/CrCl ≥ 15 mL/min/1.73 m2
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 ≤ 3 X ULN
Adequate organ function: ANC ≥ 1000/microlitre (unless patient has ethnic neutropenia); Platelets ≥ 50,000/microlitre; Hemoglobin ≥ 8 g/dL (transfusions permitted); 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 ≤ 3 X ULN; Serum creatinine ≤ 1.5 X ULN (except if due to myeloma) or eGFR/CrCl ≥ 15 mL/min/1.73 m2
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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