OncoMatch/Clinical Trials/NCT06461988
Talquetamab & Lenalidomide as Post Stem Cell Transplant Maintenance in Multiple Myeloma
Is NCT06461988 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Talquetamab and Talquetamab and Lenalidomide for multiple myeloma.
Treatment: Talquetamab · Talquetamab and Lenalidomide — Multiple myeloma (MM) is a heterogenous plasma cell malignancy characterized by clonal proliferation of plasma cells and organ damage. Autologous transplantation with high dose chemotherapy is the standard of care in frontline treatment of eligible patients with MM.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: autologous stem cell transplant — within 12 months of start of induction therapy and within day +60-120 post-transplant
Patients who have already received transplant should have undergone autologous stem cell transplant with Melphalan 140 mg/m2 within 12 months of start of induction therapy of multiple myeloma and are within day +60-120 post-transplant.
Must have received: induction therapy — within 12 months prior to the planned date of transplant
Patients who have not already received transplant must have begun induction therapy within 12 months prior to the planned date of transplant.
Cannot have received: lenalidomide (lenalidomide)
Exception: not refractory or intolerant
Participants must not be refractory to lenalidomide; Intolerance to lenalidomide 10 mg (or 5 mg for patients with creatinine clearance 30-60 ml/min).
Cannot have received: GRPRCD5-directed therapy
Received any prior GRPRCD5-directed therapy
Cannot have received: T-cell redirection therapy
Received prior T-cell redirection therapy (for example, antibody therapy or BiTE's) or Chimeric antigen T cell therapy.
Cannot have received: gene-modified adoptive cell therapy
Exception: within 3 months
Gene-modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, NK cells) within 3 months
Cannot have received: targeted therapy
Exception: within 21 days or ≥5 half-lives, whichever is less
Targeted therapy, epigenetic therapy, or 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
Exception: other than SARS CoV-2 vaccine approved/ in use under emergency approval within 4 weeks
Investigational vaccine other than SARS CoV-2 vaccine approved/ in use under emergency approval within 4 weeks
Cannot have received: live, attenuated vaccine
Exception: within 4 weeks
Live, attenuated vaccine within 4 weeks.
Cannot have received: monoclonal antibody therapy targeting multiple myeloma
Exception: within 21 days
Monoclonal antibody therapy targeting multiple myeloma within 21 days
Cannot have received: cytotoxic therapy
Exception: within 21 days
Cytotoxic therapy within 21 days
Cannot have received: proteasome inhibitor
Exception: within 14 days
PI therapy within 14 days
Cannot have received: IMiD agent
Exception: within 14 days
IMiD agent therapy within 14 days
Cannot have received: radiation therapy
Exception: within 14 days or focal radiation within 7 days
Radiotherapy within 14 days or focal radiation within 7 days
Lab requirements
Blood counts
Hemoglobin: ≥ 8 g/dL (without transfusion support or erythropoietin use within 7 days before the laboratory test); Platelets: ≥ 75×10^9/L in participants in whom <50% of bone marrow nucleated cells are plasma cells and ≥ 50×10^9/L in participants in whom ≥50% of bone marrow nucleated cells are plasma cells (without transfusion support or thrombopoietin receptor agonist within 7 days before the laboratory test); Absolute neutrophil count: ≥ 1.0×10^9/L (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 GCSF before the laboratory test)
Kidney function
Creatinine clearance: ≥30 mL/min based on Cockcroft Gault equation
Liver function
AST and ALT: ≤2.5×ULN; Total bilirubin: ≤2.0×ULN; except in participants with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin ≤1.5×ULN is required)
Cardiac function
New York Heart Association stage III or IV congestive heart failure, myocardial infarction or coronary artery bypass graft ≤6 months prior to randomization, uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities, history of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration, history of severe non-ischemic cardiomyopathy [excluded]
Have clinical laboratory values meeting the following criteria during the Screening Phase and also at start of administration of study treatment: Hemoglobin: ≥ 8 g/dL... Platelets: ≥ 75×10^9/L... Absolute neutrophil count: ≥ 1.0×10^9/L... AST and ALT: ≤2.5×ULN; Creatinine clearance: ≥30 mL/min; Total bilirubin: ≤2.0×ULN; Serum calcium corrected for albumin: ≤14 mg/dL or free ionized calcium ≤6.5 mg/dL. Cardiac exclusion: New York Heart Association stage III or IV congestive heart failure, myocardial infarction or coronary artery bypass graft ≤6 months prior to randomization, uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities, history of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration, history of severe non-ischemic cardiomyopathy.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Stanford University · Palo Alto, California
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