Talquetamab & Lenalidomide as Post Stem Cell Transplant Maintenance in Multiple Myeloma

NCT06461988 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: IRB-73317NCI-2024-06734
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Myeloma; Post Stem Cell Transplant

Keywords

Talequetamab; Lenalidomide

Outcome Measures

Primary Outcomes (1)

• Stringent Complete Response (sCR) + Complete Response (CR) Rate

  The primary outcome for this study, for the purposes of Clinical Trials.gov registration and results reporting, is the percentage of patients in complete response at 12 months.

  12 months after the start of talquetamab in each participant.

Secondary Outcomes (4)

• Minimal Residual Disease (MRD) negativity (10^-5) (ClonoSeqTM)

  2 years

• Progression free survival (PFS) and overall survival (OS)

  4 years

• Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), and hematologic and non-hematologic toxicities per NCI CTCAE v5 criteria

  1 year and 1 months post first patient treatment start

• Quality of life - PROMIS® (Patient-Reported Outcomes Measurement Information System and Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®)

  2 years

Study Arms (1)

Talquetamab

EXPERIMENTAL

Study participants will receive talquetamab (JNJ-64407564) for one cycle and a combination of talquetamab and lenalidomide for cycles 2-13 after autologous stem cell transplant (ASCT).

Drug: Talquetamab; Drug: Talquetamab and Lenalidomide

Interventions

Talquetamab DRUG

Talquetamab Step up dosing: C1D1: 10 mcg/kg C1D3: 60 mcg/kg C1D5: 400 mcg/kg C1D15: 800 mcg/kg Talquetamab 800 mg/kg SC Q4W in 28-day cycle for Cycles 2-13

Talquetamab

Talquetamab and Lenalidomide DRUG

Lenalidomide 10 mg, 3 weeks on 1 week off, until PD/ intolerance, C2-13 (Lenalidomide 5 mg for creatinine clearance 30-60 ml/min)

Talquetamab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have had a confirmed diagnosis of symptomatic multiple myeloma according to according to IMWG diagnostic criteria.
• Measurable disease at the time of myeloma diagnosis Measurable disease is defined as measurable M protein in the serum (≥ 0.5g/dL) or urine (≥ 200 mg/24h) or serum free light chain assay (defined as dFLC ≥ 10 mg/dL \[≥ 100 mg/L\]; difference between involved and uninvolved free light chain) at the time of diagnosis. Participants with smoldering myeloma are not eligible until they have progressed to symptomatic myeloma. Participants with purely non-secretory MM at the time of diagnosis as measured by electrophoresis and immunofixation and the absence of Bence Jones proteins in the urine are not eligible.
• Age \>18 years.
• 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. Patients who have not already received transplant must have begun induction therapy within 12 months prior to the planned date of transplant.
• Participants must not be refractory to lenalidomide
• Participants must not have progressive disease at any time prior to registration
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
• 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 (≥ 4.96 mmol/L; without transfusion support or erythropoietin use within 7 days before the laboratory test)
• \- Platelets: ≥ 75×109/L in participants in whom \<50% of bone marrow nucleated cells are plasma cells and ≥ 50×109/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: ≥ 1.0×109/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)
• \- AST and ALT: ≤2.5×ULN
• Creatinine clearance: ≥30 mL/min based on Cockcroft Gault equation
• 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)
• Serum calcium corrected for albumin: ≤14 mg/dL (≤3.5 mmol/L) or free ionized calcium ≤6.5 mg/dL

You may not qualify if:

• Intolerance to lenalidomide 10 mg (or 5 mg for patients with creatinine clearance 30-60 ml/min).
• Refractory or relapsed multiple myeloma at any time before enrollment
• Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients (refer to the talquetamab Investigator's Brochure and appropriate package inserts).
• Prior or concurrent exposure to any of the following, in the specified time frame as defined below:
• a. Received any prior GRPRCD5-directed therapy b. Received prior T-cell redirection therapy (for example, antibody therapy or BiTE's) or Chimeric antigen T cell therapy.
• b. Gene-modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, NK cells) within 3 months
• c. 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
• d. Investigational vaccine other than SARS CoV-2 vaccine approved/ in use under emergency approval within 4 weeks
• e. Live, attenuated vaccine within 4 weeks.
• f. Monoclonal antibody therapy targeting multiple myeloma within 21 days
• g. Cytotoxic therapy within 21 days i PI therapy within 14 days
• h. IMiD agent therapy within 14 days
• i. Radiotherapy within 14 days or focal radiation within 7 days
• A maximum cumulative dose of corticosteroids of ≥ 140 mg of prednisone or equivalent within 14-day period before the first dose of study drug (does not include pretreatment medications) (Section 13.8, Appendix 8)
• Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain MRI and lumbar cytology are required.

Sponsors & Collaborators

• Stanford University: lead
• Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

talquetamab; Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Surbhi Sidana, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly Xie

CONTACT

650-725-9363; kimbtxie@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 17, 2024
• Study Start: June 5, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 17, 2026

Record last verified: 2026-07

Locations

US (1)