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 (Jun 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
Treatments studied
Immunotherapy
Other
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.
Frequently asked questions
Is NCT06918002 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages