Actively Recruiting
Subcutaneous Talquetamab in Elderly Patients With Multiple Myeloma in Early Relapse
Led by Larysa Sanchez · Updated on 2025-12-18
23
Participants Needed
1
Research Sites
110 weeks
Total Duration
On this page
Sponsors
L
Larysa Sanchez
Lead Sponsor
J
Janssen Research & Development, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Induction therapy approaches in recent years have evolved, now utilizing triple or quadruple drug regimens in the majority of patients. By combining anti-CD38 antibodies, proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), and steroids, patients achieve longer remissions with their first- and second-line therapies but also become refractory to most or all three major drug classes earlier. For patients who are refractory to at least 3 of the commonly administered PIs and IMiDs, occurring after 2 lines of therapy in many, the median overall survival is only 5 months. Elderly, frail patients are not often candidates at this point for aggressive therapies like stem cell transplantation and CAR T-cell therapy thus necessitating effective yet tolerable treatments for elderly patients in early relapse (1-3 prior therapy). Talquetamab is a GPRC5DxCD3 bispecific antibody that redirects patients' T cells to myeloma cells which express GPRC5D. In the phase 1 MonumenTAL-1, heavily pretreated patients with a median of 6 prior lines of therapy attained a 70% response rate with 405 μg/kg of subcutaneous (SC) talquetamab. Importantly, subcutaneous talquetamab was found to be tolerable for the treated population, which included 28% of patients aged ≥70, with only three patients experiencing dose-limiting toxicities in the form of grade 3 rashes which responded to steroids. The anti-CD38 antibody daratumumab eliminates CD38-positive T and B regulatory cells, potentiates the activity of bispecific antibodies like talquetamab, and may improve its efficacy when used in combination. The aim of this study will be to assess the efficacy and safety of treating elderly patients with relapsed/refractory multiple myeloma with at least ≥2 prior lines of therapy with subcutaneous talquetamab. Patients who have progressive disease on talquetamab or who fail to respond after 3 cycles will have subcutaneous daratumumab added to their regimen.
CONDITIONS
Official Title
Subcutaneous Talquetamab in Elderly Patients With Multiple Myeloma in Early Relapse
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of multiple myeloma according to IMWG criteria
- Measurable disease at screening by serum or urine M-protein or abnormal free light chain ratio
- Relapsed or refractory multiple myeloma after at least 1 prior line of therapy with 2 consecutive cycles
- Received at least 2 prior systemic antimyeloma therapies including a proteasome inhibitor and an immunomodulatory drug
- Anti-CD38 antibody-nafve or exposed in Part 2; refractory patients allowed in Part 1 only
- Hemoglobin 7 g/dL without recent transfusion or erythropoietin
- Platelet count 50x10^9/L without recent transfusion or thrombopoietin agonist
- Absolute neutrophil count 1.0x10^9/L without recent growth factor support
- Liver enzymes (AST and ALT) 2.5 times upper limit of normal
- Estimated glomerular filtration rate 30 mL/min
- Total bilirubin 2.0 times upper limit of normal, with exceptions for certain conditions
- Corrected serum calcium 14 mg/dL or free ionized calcium 6.5 mg/dL
- HIV-positive patients with controlled viral load and CD4+ count over 300 cells/mm3
- Male participants agree to use condoms and not donate sperm during study and 100 days after
- Willingness and ability to follow study restrictions
- Signed informed consent form
You will not qualify if you...
- Allergy or intolerance to study drugs or their ingredients
- Prior treatment with T-cell-engaging antibodies or GPRC5D-directed therapy
- Recent gene-modified cell therapy, investigational drugs, vaccines, or radiotherapy within specified timeframes
- Unresolved toxicities from previous cancer treatments above Grade 1 except alopecia or neuropathy
- Recent high-dose corticosteroids or stem cell transplantation within specified periods
- Active central nervous system myeloma involvement or plasma cell leukemia
- Other active or recent malignancies except certain treated cancers with low recurrence risk
- Stroke or seizure within 6 months before consent
- Active hepatitis B or C infection unless treated and undetectable
- Medical or psychiatric conditions interfering with study participation
- History of non-compliance with medical treatments
- Planning to father a child during study or 100 days after last dose
- Certain serious cardiac conditions
- Major surgery within 2 weeks before or planned during study
- Severe chronic obstructive pulmonary disease or uncontrolled asthma
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
N
Nicole K DeVito, BSc
CONTACT
L
Lupita Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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