OncoMatch/Clinical Trials/NCT06974786
Frontline T-cell Engager vs Autologous Stem Cell Transplant (ASCT) and Measurable Residual Disease (MRD)-Guided Sequential Intensification thERapy in Multiple Myeloma
Is NCT06974786 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Elranatamab and Daratumumab for multiple myeloma, newly diagnosed.
Treatment: Elranatamab · Daratumumab · Lenalidomide — This is an open-label, multi-site, Phase II randomized trial with response-adaptive design for newly diagnosed multiple myeloma (NDMM) participants who have had prior induction therapy. The primary objective of this study is to compare the rates of achieving undetectable measurable residual disease (MRD) in the bone marrow with elranatamab and daratumumab employed as post-induction consolidation and maintenance treatment (Arm A) versus autologous stem cell transplant (ASCT) followed by lenalidomide and daratumumab treatment (Arm B).
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: proteasome inhibitor — induction
Prior induction therapy including one PI, lenalidomide, and an anti-CD38 mAb for 16-24 weeks, obtaining at least a partial response (PR).
Must have received: immunomodulatory agent (lenalidomide) — induction
Prior induction therapy including one PI, lenalidomide, and an anti-CD38 mAb for 16-24 weeks, obtaining at least a partial response (PR).
Must have received: anti-CD38 monoclonal antibody — induction
Prior induction therapy including one PI, lenalidomide, and an anti-CD38 mAb for 16-24 weeks, obtaining at least a partial response (PR).
Must have received: stem cell mobilization and collection
Prior completion of standard of care mobilization and collection of stem cells (minimum 2 × 10^6 CD34+ cells/kg) without use of chemotherapy mobilization, any time prior to or during screening phase.
Cannot have received: anti-BCMA therapy
Any anti-BCMA therapy
Cannot have received: epigenetic therapy
Epigenetic therapy
Cannot have received: investigational drug
treatment with an investigational drug or an invasive investigational medical device within 21 days or ≥5 half-lives, whichever is less
Cannot have received: investigational vaccine
Investigational vaccine within 4 weeks
Cannot have received: live, attenuated vaccine
Live, attenuated vaccine within 4 weeks before randomization
Cannot have received: radiation therapy
Radiotherapy within 14 days
Cannot have received: gene-modified adoptive cell therapy
Gene-modified adoptive cell therapy (e.g., CAR modified T cells, NK cells)
Cannot have received: cytotoxic chemotherapy
Cytotoxic therapy within 14 days
Cannot have received: third-generation EGFR TKI
Cannot have received: allogeneic bone marrow, hematopoietic stem cell or solid organ transplant
Prior allogeneic bone marrow, hematopoietic stem cell or solid organ transplant
Lab requirements
Blood counts
Hemoglobin ≥8g/dL without prior RBC transfusion within 14 days before the laboratory test; Platelets ≥75,000/µl; Absolute neutrophil count ≥1,000/µl (prior growth factor support is permitted but must be without support for 7 days for G-CSF or GM-CSF and for 14 days for pegylated G-CSF before screening lab test)
Kidney function
Creatinine clearance (CrCl) ≥40 mL/min based on calculation using Cockcroft-Gault formula or measured by a 24-hour urine collection
Liver function
Aspartate aminotransferase and alanine aminotransferase ≤2.5 × ULN; Total bilirubin ≤2 × ULN, except in participants with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin ≤3 × ULN is required)
Have clinical laboratory values meeting the following criteria during the Screening Phase and also at start of administration of study treatment: Hemoglobin ≥8g/dL without prior red blood cells (RBC) transfusion within 14 days before the laboratory test; recombinant human erythropoietin use is permitted; Platelets ≥75,000/µl; Absolute neutrophil count ≥1,000/µl (prior growth factor support is permitted but must be without support for 7 days for granulocyte colony stimulating factor (G-CSF) or granulocyte-macrophage colony stimulating Factor (GM-CSF) and for 14 days for pegylated G-CSF before screening lab test); Aspartate aminotransferase and alanine aminotransferase ≤2.5 × upper limit of normal (ULN); Renal function: Creatinine clearance (CrCl) ≥40 mL/min based on calculation using Cockcroft-Gault formula or measured by a 24-hour urine collection; Total bilirubin ≤2 × ULN, except in participants with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin ≤3 × ULN is required); Serum calcium corrected for albumin ≤14 mg/dL (≤3.5 mmol/L) or free ionized calcium ≤6.5 mg/dL (≤1.6 mmol/L)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham · Birmingham, Alabama
- Colorado Blood Cancer Institute · Denver, Colorado
- University of Iowa · Iowa City, Iowa
- University of North Carolina · Chapel Hill, North Carolina
- Oncology Hematology Care · Cincinnati, Ohio
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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