External Beam Radiation Therapy in Combination With Talquetamab for the Treatment of Multiple Myeloma Patients With Extramedullary Disease
- Conditions
- Extramedullary Disease in Multiple MyelomaMultiple Myeloma
- Registration Number
- NCT06572605
- Lead Sponsor
- City of Hope Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria:<br><br> - Documented informed consent of the participant and/or legally authorized<br> representative<br><br> - Assent, when appropriate, will be obtained per institutional guidelines<br><br> - Agreement to allow the use of archival tissue from diagnostic tumor biopsies<br><br> - If unavailable, exceptions may be granted with study principal investigator<br> (PI) approval<br><br> - Age: = 18 years<br><br> - Karnofsky performance status (KPS) = 60%<br><br> - Diagnosis of multiple myeloma with extramedullary disease (EMD). EMD is defined as<br> soft-tissue plasmacytomas NOT arising from skeletal lesions (i.e., the EMD is not<br> contiguous with any bone/bony lesion)<br><br> - Measurable systemic disease defined as serum M-spike = 0.5 g/dl, 24-hour urine<br> M-spike = 200 mg/24 hours (hr), involved serum free light chain (FLC) = 10 mg/dl<br> with abnormal FLC ratio, and/or a non-target plasmacytoma = 2 cm in a single<br> diameter (NOTE: Non-target plasmacytoma must not be included in the EMD-EBRT field)<br><br> - At least one site of EMD must have an indication for palliative radiation per the<br> treating clinicians (e.g., including but not limited to pain, asymmetry, discomfort,<br> threatening to vital structure, etc.)<br><br> - Target EMD site must be encompassed by one radiation field per treating radiation<br> oncologist<br><br> - Subject must have received an immunomodulatory agent, a proteasome inhibitor, and an<br> anti-CD38 antibody<br><br> - Fully recovered from the acute non-hematologic toxic effects (except alopecia) to =<br> grade 1 to prior anti-cancer therapy<br><br> - Prior antitumor therapy must have been completed prior to enrollment as follows:<br><br> - = 2 weeks for prior external beam radiotherapy (XRT) to non-target site<br><br> - = 21 days for cytotoxic chemotherapy (systemic or intrathecal)<br><br> - = 28 days for prior adoptive cell therapy or T-cell redirecting therapies<br><br> - = 4 weeks or 5 half-lives (whichever is shorter) for other myeloma therapies<br><br> - Absolute neutrophil count (ANC) = 1,000/mm^3 (prior growth factor support is<br> permitted but must be without support for 7 days for granulocyte colony-stimulating<br> factor [G-CSF] or granulocyte-macrophage colony-stimulating factor [GM-CSF] and for<br> 14 days for pegylated GCSF before the laboratory test)<br><br> - Two repeat tests are allowed. If the repeat test satisfies criteria, the<br> participant may enroll provided all other criteria are met<br><br> - Platelets = 50,000/mm^3<br><br> - NOTE: No transfusion support or thrombopoietin receptor agonist within 7 days<br> before laboratory test<br><br> - Two repeat tests are allowed. If the repeat test satisfies criteria, the<br> participant may enroll provided all other criteria are met<br><br> - Hemoglobin = 8g/dL<br><br> - NOTE: No transfusion support or erythropoietin use within 7 days before the<br> laboratory test<br><br> - Two repeat tests are allowed. If the repeat test satisfies criteria, the<br> participant may enroll provided all other criteria are met<br><br> - Total bilirubin = 2.0 X upper limit of normal (ULN) (unless has congenital<br> bilirubinemia such as Gilbert's disease, in which case = 1.5 × ULN is required)<br><br> - Two repeat tests are allowed. If the repeat test satisfies criteria, the<br> participant may enroll provided all other criteria are met<br><br> - Aspartate aminotransferase (AST) = 2.5 x ULN<br><br> - Two repeat tests are allowed. If the repeat test satisfies criteria, the<br> participant may enroll provided all other criteria are met<br><br> - Alanine aminotransferase (ALT) = 2.5 x ULN<br><br> - Two repeat tests are allowed. If the repeat test satisfies criteria, the<br> participant may enroll provided all other criteria are met<br><br> - Creatinine clearance of = 30 mL/min per 24 hour urine test or the Cockcroft-Gault<br> formula<br><br> - Two repeat tests are allowed. If the repeat test satisfies criteria, the<br> participant may enroll provided all other criteria are met<br><br> - Women of childbearing potential (WOCBP): negative urine or serum pregnancy test<br><br> - If the urine test is positive or cannot be confirmed as negative, a serum<br> pregnancy test will be required<br><br> - Two repeat tests are allowed. If the repeat test satisfies criteria, the<br> participant may enroll provided all other criteria are met<br><br> - Agreement by females and males of childbearing potential to use an effective method<br> of birth control or abstain from heterosexual activity for the course of the study<br> through at least 6 months after the last dose of talquetamab<br><br> - Childbearing potential defined as not being surgically sterilized (men and<br> women) or have not been free from menses for > 1 year (women only)<br><br>Exclusion Criteria:<br><br> - Prior irradiation to target EMD site or field<br><br> - Prior GPRC5D therapy<br><br> - Prior radiopharmaceutical therapy<br><br> - Patients who have received previous radiation to > 25% of their bone marrow<br><br> - Prior allogeneic hematopoietic cell transplantation within the past 6 months or<br> prior autologous hematopoietic cell transplantation within the past 12 weeks<br><br> - A maximum cumulative dose of corticosteroids of = 140 mg of prednisone or equivalent<br> within 14-day period before the first dose of study drug (does not include<br> pre-treatment medications)<br><br> - Major surgery within 2 weeks prior to the start of administration of study<br> treatment, or will not have fully recovered from surgery, or has major surgery<br> planned during the time the participant is expected to be treated in the study, or<br> within 2 weeks after administration of the last dose of study treatment<br><br> - Note: Participants with planned surgical procedures to be conducted under local<br> anesthesia may participate. Kyphoplasty or vertebroplasty are not considered<br> major surgery. If there is a question whether a procedure is considered a major<br> surgery, the investigator must consult with the appropriate representative at<br> Janssen and resolve any issues before enrolling a participant in the study<br><br> - Ongoing or active infection<br><br> - Severe persistent asthma or severe chronic obstructive pulmonary disease (COPD)<br><br> - Presence of the following cardiac conditions:<br><br> - New York Heart Association stage III or IV congestive heart failure<br><br> - Myocardial infarction or coronary artery bypass graft = 6 months prior to<br> randomization<br><br> - Uncontrolled cardiac arrhythmia or clinically significant electrocardiogram<br> (ECG) abnormalities<br><br> - History of clinically significant ventricular arrhythmia or unexplained<br> syncope, not believed to be vasovagal in nature or due to dehydration<br><br> - History of severe non-ischemic cardiomyopathy<br><br> - Any of the following:<br><br> - Hepatitis B infection (i.e., hepatitis B virus surface antigen [HBsAg] or<br> hepatitis B virus [HBV]-deoxyribonucleic acid [DNA] positive). In the event the<br> infection status is unclear, quantitative viral levels are necessary to<br> determine the infection status<br><br> - Active hepatitis C infection as measured by positive hepatitis C virus<br> [HCV]-ribonucleic acid [RNA]
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of adverse events (phase 1b);Extramedullary disease (EMD)-modified overall response rate (ORR) (phase 2)
- Secondary Outcome Measures
Name Time Method Progression-free survival;Overall survival;Duration of response;Clinical benefit rate;Incidence of adverse events