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New treatment option for Extramedullary Disease in Multiple Myeloma
Official title External Beam Radiation Therapy in Combination With Talquetamab for the Treatment of Multiple Myeloma Patients With Extramedullary Disease
ClinicalTrials.gov ID: NCT06572605
What this study is testing
What is Talquetamab?
Talquetamab is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for extramedullary disease in multiple myeloma.
Also referred to as Anti-CD3/Anti-GPRC5D Bispecific Monoclonal Antibody JNJ-64407564, GPRC5D x CD3 Bispecific Antibody JNJ-64407564.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase I/II trial tests the safety and effectiveness of extramedullary disease (EMD)-directed external beam radiation therapy (EBRT) in combination with talquetamab for the treatment of multiple myeloma patients with extramedullary disease. Extramedullary disease in multiple myeloma involves the infiltration of organs and soft tissues by malignant plasma cells and has proven difficult to treat.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Documented informed consent of the participant and/or legally authorized representative
- Assent, when appropriate, will be obtained per institutional guidelines
- Agreement to allow the use of archival tissue from diagnostic tumor biopsies
- If unavailable, exceptions may be granted with study principal investigator (PI) approval
- Age: ≥ 18 years
You likely can't join if
- Prior irradiation to target EMD site or field
- Prior GPRC5D therapy
- Prior radiopharmaceutical therapy
- Patients who have received previous radiation to \> 25% of their bone marrow
- Prior allogeneic hematopoietic cell transplantation within the past 6 months or prior autologous hematopoietic cell transplantation within the past...
- 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...
See the full eligibility criteria
Who can join
- Documented informed consent of the participant and/or legally authorized representative
- Assent, when appropriate, will be obtained per institutional guidelines
- Agreement to allow the use of archival tissue from diagnostic tumor biopsies
- If unavailable, exceptions may be granted with study principal investigator (PI) approval
- Age: ≥ 18 years
- Karnofsky performance status (KPS) ≥ 60%
- Diagnosis of multiple myeloma with extramedullary disease (EMD). EMD is defined as soft-tissue plasmacytomas NOT arising from skeletal lesions (i.e., the EMD is not contiguous with any bone/bony lesion)
- Measurable systemic disease defined as serum M-spike ≥ 0.5 g/dl, 24-hour urine M-spike ≥ 200 mg/24 hours (hr), involved serum free light chain (FLC) ≥ 10 mg/dl with abnormal FLC ratio, and/or a non-target plasmacytoma ≥...
- At least one site of EMD must have an indication for palliative radiation per the treating clinicians (e.g., including but not limited to pain, asymmetry, discomfort, threatening to vital structure, etc.)
- Target EMD site must be encompassed by one radiation field per treating radiation oncologist
- Subject must have received an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody
- Fully recovered from the acute non-hematologic toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy
- Prior antitumor therapy must have been completed prior to enrollment as follows:
- ≥ 2 weeks for prior external beam radiotherapy (XRT) to non-target site
- ≥ 21 days for cytotoxic chemotherapy (systemic or intrathecal)
- ≥ 28 days for prior adoptive cell therapy or T-cell redirecting therapies
- ≥ 4 weeks or 5 half-lives (whichever is shorter) for other myeloma therapies
- Absolute neutrophil count (ANC) ≥ 1,000/mm\^3 (prior growth factor support is permitted but must be without support for 7 days for granulocyte colony-stimulating factor [G-CSF] or granulocyte-macrophage...
- Two repeat tests are allowed. If the repeat test satisfies criteria, the participant may enroll provided all other criteria are met
- Platelets ≥ 50,000/mm\^3
- NOTE: No transfusion support or thrombopoietin receptor agonist within 7 days before laboratory test
- Two repeat tests are allowed. If the repeat test satisfies criteria, the participant may enroll provided all other criteria are met
- Hemoglobin ≥ 8g/dL
- NOTE: No transfusion support or erythropoietin use within 7 days before the laboratory test
- Two repeat tests are allowed. If the repeat test satisfies criteria, the participant may enroll provided all other criteria are met
- Total bilirubin ≤ 2.0 X upper limit of normal (ULN) (unless has congenital bilirubinemia such as Gilbert's disease, in which case ≤ 1.5 × ULN is required)
- Two repeat tests are allowed. If the repeat test satisfies criteria, the participant may enroll provided all other criteria are met
- Aspartate aminotransferase (AST) ≤ 2.5 x ULN
- Two repeat tests are allowed. If the repeat test satisfies criteria, the participant may enroll provided all other criteria are met
- Alanine aminotransferase (ALT) ≤ 2.5 x ULN
- Two repeat tests are allowed. If the repeat test satisfies criteria, the participant may enroll provided all other criteria are met
- Creatinine clearance of ≥ 30 mL/min per 24 hour urine test or the Cockcroft-Gault formula
- Two repeat tests are allowed. If the repeat test satisfies criteria, the participant may enroll provided all other criteria are met
- Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
- If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Two repeat tests are allowed. If the repeat test satisfies criteria, the participant may enroll provided all other criteria are met
- Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of...
- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
What rules you out
- Prior irradiation to target EMD site or field
- Prior GPRC5D therapy
- Prior radiopharmaceutical therapy
- Patients who have received previous radiation to \> 25% of their bone marrow
- Prior allogeneic hematopoietic cell transplantation within the past 6 months or prior autologous hematopoietic cell transplantation within the past 12 weeks
- 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 pre-treatment medications)
- Major surgery within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated...
- Note: Participants with planned surgical procedures to be conducted under local anesthesia may participate. Kyphoplasty or vertebroplasty are not considered major surgery. If there is a question whether a procedure is...
- Ongoing or active infection
- Severe persistent asthma or severe chronic obstructive pulmonary disease (COPD)
- Presence of the following cardiac conditions:
- 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 electrocardiogram (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
- Any of the following:
- Hepatitis B infection (i.e., hepatitis B virus surface antigen [HBsAg] or hepatitis B virus [HBV]-deoxyribonucleic acid [DNA] positive). In the event the infection status is unclear, quantitative viral levels are...
- Active hepatitis C infection as measured by positive hepatitis C virus [HCV]-ribonucleic acid [RNA] testing. Participants with a history of HCV antibody positivity must undergo HCV-RNA testing. If a participant with...
- Plasma cell leukemia (\> 20% circulating plasma cells and/or \> 2.0 x 10\^9/L plasma cells) at the time of screening, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy...
- Known active central nervous system (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
- Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational...
- Stroke or seizure within 6 months prior to enrollment
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
- If HIV positive, any of the following:
- Detectable viral load at screening
- CD4+ T cell count ≤ 300
- AIDS-defining opportunistic infection within 6 months of screening
- Changes in highly active antiretroviral therapy (HAART) due to resistance/progression that occurred within 3 months prior to screening
- Changes in HAART due to toxicity within 4 weeks prior to screening
- Females only: Pregnant or breastfeeding
- Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.