OncoMatch/Clinical Trials/NCT06918002
Elranatamab/Lenalidomide Consolidation and/or Elranatamab Maintenance Versus Standard of Care After D-VRd Induction in Transplant-eligible NDMM Patients
Is NCT06918002 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for multiple myeloma, newly diagnosed.
Treatment: Elranatamab · Lenalidomide (Revlimid®) · Daratumumab SC (Darzalex) · Bortezomib (Velcade®) · Dexamethasone — This study is designed as a multicenter, randomized, parallel groups, open-label, phase 3 study in subjects with untreated newly diagnoses Multiple Myeloma eligible for ASCT. 824 patients will be enrolled in this study from approximately 70 study sites. The 2 parts in the Treatment Phase are described below. Part 1: Induction/ASCT/Consolidation Phase (1:1 Randomization) After the screening period, patients will be randomly allocated (1:1) to either: * Arm A (standard of care arm): standard induction therapy with 4 cycles of D-VRd, followed by HDCT (Melphalan) + ASCT, D-VRd consolidation therapy * Arm B (experimental arm): standard induction therapy with 4 cycles of D-VRd, followed by elranatamab and lenalidomide consolidation therapy. Part 2: Maintenance Phase (1:1 Re-randomization) Patients will be re-randomized (1:1) and will enter the Maintenance Phase upon completion of consolidation therapy. * Arm C (standard of care arm): lenalidomide * Arm D (experimental arm): elranatamab
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic therapy for multiple myeloma
Exception: corticosteroids during screening not >160 mg dexamethasone (or equivalent)
Subjects previously treated with any systemic therapy for multiple myeloma. Patients are allowed corticosteroids during screening not >160 mg of dexamethasone (or equivalent).
Cannot have received: radiotherapy
Exception: localized radiotherapy within 14 days before initiating induction therapy not allowed
Patients with concurrent radiotherapy (localized) within the 14 days before initiating induction therapy are not eligible
Cannot have received: plasmapheresis
The subject has had plasmapheresis within 14 days of initiating induction therapy.
Lab requirements
Blood counts
Hemoglobin ≥7.5 g/dL (≥5 mmol/L); ANC ≥1.0 G/L; Platelet count ≥50 G/L for subjects with <50% bone marrow plasma cells, otherwise >30 G/L (no platelet transfusions in prior 15 days)
Kidney function
Calculated creatinine clearance ≥40 mL/min/1.73 m²
Liver function
AST ≤3 x ULN; ALT ≤3 x ULN; total bilirubin ≤3 x ULN (except congenital bilirubinemia: direct bilirubin ≤3 x ULN)
Cardiac function
No clinically significant cardiac disease (e.g., MI within 1 year, unstable angina, CHF NYHA III-IV, uncontrolled arrhythmia CTCAE v4 grade ≥2, QTcF >470 msec)
Patients must have clinical laboratory values (within 15 days of initiating induction therapy) as follows: Hemoglobin ≥7.5 g/dL (≥5 mmol/L)... ANC ≥1.0 G/L... AST ≤3 x ULN... ALT ≤ 3 x ULN... Total bilirubin ≤3 x ULN (except in subjects with congenital bilirubinemia, such as Gilbert syndrome, that require a direct bilirubin ≤3 x ULN)... Calculated creatinine clearance ≥40 mL/min/1.73 m²... Albumin corrected serum calcium ≤14 mg/dL (<3.5 mmol/L); or free-ionized calcium ≤6.5 mg/dL (≤1.6 mmol/L)... Platelet count ≥50 Giga/L for subjects who have <50% of bone marrow nucleated cells as plasma cells. If not, platelet count >30 G/L (platelets transfusions done during the 15 days before initiating induction therapy are not permitted). Subject has clinically significant cardiac disease, including: Subject has had myocardial infarction within 1 year before initiating induction therapy, or currently has an unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association [NYHA] class III IV). Subject has uncontrolled cardiac arrhythmia (common terminology criteria for adverse events [CTCAE] version 4 grade ≥2) or clinically significant electrocardiography (ECG) abnormalities. Subject with a baseline QT interval as corrected by Fridericia's formula (QTcF) >470 msec (12-lead ECG).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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