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 (Sep 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): daratumumab + lenalidomide approx 2 years. Subjects with a negative MRD (for at least 12 months) after 24 cycles of daratumumab-lenalidomide will discontinue daratumumab and continue with lenalidomide monotherapy until disease progression, or study cut-off date (whichever occurs first). Subjects who did not achieve MRD negativity for at least 12 months after 24 cycles of daratumumab-lenalidomide will continue to receive daratumumab-lenalidomide until: * MRD negativity for at least 12 months is reached. Subjects will then continue with lenalidomide monotherapy until disease progression, or study cut-off date (whichever occurs first). * Disease progression * Or study cut-off date (whichever occurs first). * Arm D (experimental arm): elranatamab. Approx 2 years. Subjects with a negative MRD (for at least 12 months) after receiving M22 administration of elranatamab will discontinue study treatment with elranatamab. Subjects who did not achieve MRD negativity for at least 12 months after M22 elranatamab administration will continue to receive elranatamab, every 24 weeks, until MRD negativity for at least 12 months is reached, disease progression, or study cut-off date (whichever occurs first).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: systemic therapy for multiple myeloma
Exception: corticosteroids allowed if total dose ≤160 mg dexamethasone (or equivalent) within 14 days before initiating induction therapy
Subjects previously treated with any systemic therapy for multiple myeloma. Patients are allowed corticosteroids before or during screening, as far as the total dose received is not >160 mg of dexamethasone (or equivalent) within 14 days before initiating induction therapy.
Lab requirements
Blood counts
hemoglobin ≥7.5 g/dL (≥5 mmol/L); ANC ≥1.0 G/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
Kidney function
calculated creatinine clearance ≥40 mL/min/1.73 m²; renal insufficiency: creatinine clearance < 40mL/min/1.73 m2 or serum creatinine >177 μmol/L (>2 mg/dL) [defining event]
Liver function
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)
Cardiac function
no clinically significant cardiac disease; no myocardial infarction within 1 year; no unstable angina, congestive heart failure (NYHA class III-IV); no uncontrolled cardiac arrhythmia (CTCAE v4 grade ≥2); no clinically significant ECG abnormalities; baseline 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). Prior red blood cell (RBC) transfusion or the use of recombinant human erythropoietin is permitted. Absolute neutrophil count (ANC) ≥1.0 G/L (granulocyte colony stimulating factor [G-CSF] use is permitted). Aspartate aminotransferase (AST) ≤3 x ULN. Alanine aminotransferase (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).
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.
Is there an age limit?
Yes. Patients must be 69 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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