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New treatment option for Relapsed Refractory Multiple Myeloma (RRMM)
Official title ELISA in Relapsed/Refractory MM
ClinicalTrials.gov ID: NCT06832865
What this study is testing
What is elranatamab?
elranatamab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for relapsed refractory multiple myeloma (rrmm).
Also referred to as PF-06863135.
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 is an open-label phase 2 study of elranatamab in combination with isatuximab administered subcutaneously in patients with relapsed and refractory multiple myeloma (RRMM) who have received at least two prior lines of therapy and who have had previous treatment with both immunomodulatory drugs (IMiDs) and a proteasome inhibitor (PI). The subcutaneous injection method of isatuximab administration, including the device used to administer isatuximab, is investigational.
- Phase 2: a mid-size study of how well it works
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
- 1\. This study will enroll patients with relapsed and refractory multiple myeloma who have had at least 2 prior lines of therapy including patients...
- 2\. Measurable disease of multiple myeloma as defined by at least one of the following:
- a. Serum monoclonal protein ≥ 0.5 g/dL. Patients with IgD disease and lower amounts of monoclonal protein may be permitted to enroll with PI approval
- b. ≥ 200 mg of monoclonal protein in the urine on 24-hour electrophoresis
- c. Serum free light chain ≥ 100 mg/L (10 mg/dL) and abnormal serum free kappa to serum free lambda light chain (FLC) ratio (\ 1.65)
You likely can't join if
- 1\. Patients with active plasma cell leukemia, POEMS syndrome, or amyloidosis are excluded from this trial.
- 2\. Stem cell transplant within 12 weeks prior to enrollment, or active GVHD.
- 3\. Ongoing Grade ≥2 peripheral sensory or motor neuropathy.
- 4\. History of any grade peripheral sensory or motor neuropathy with prior BCMA directed therapy. History of GBS or GBS variants, or history of any...
- 5\. Previous treatment with an anti-BCMA bispecific T cell engager. --a. Prior treatment with anti-BCMA CAR-T and/or ADC therapy is permitted...
- 6\. Participants who are receiving any investigational agents currently.
See the full eligibility criteria
Who can join
- 1\. This study will enroll patients with relapsed and refractory multiple myeloma who have had at least 2 prior lines of therapy including patients who have had previous treatment with both immunomodulatory drugs...
- 2\. Measurable disease of multiple myeloma as defined by at least one of the following:
- a. Serum monoclonal protein ≥ 0.5 g/dL. Patients with IgD disease and lower amounts of monoclonal protein may be permitted to enroll with PI approval
- b. ≥ 200 mg of monoclonal protein in the urine on 24-hour electrophoresis
- c. Serum free light chain ≥ 100 mg/L (10 mg/dL) and abnormal serum free kappa to serum free lambda light chain (FLC) ratio (\ 1.65)
- 3\. Age ≥18 years. --a. The effects of elranatamab and isatuximab on the developing human fetus are unknown. For this reason and because anti-BCMA bispecific antibodies are known to be teratogenic, women of...
- 4\. ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
- 5\. Participants must have adequate organ and marrow function as defined below:
- a. ANC ≥ 1000/μL. G-CSF is not permitted within 7 days of screening.
- b. Platelet count ≥ 50,000/µL. Platelet transfusion is not permitted within 7 days of screening.
- c. Hemoglobin ≥ 8 g/dL. Red blood cell transfusions are permitted to meet eligibility criteria.
- d. Calculated creatinine clearance of ≥ 30 mL/min by Cockcroft-Gault equation.
- e. Patient has adequate hepatic function, as evidenced by each of the following:
- Serum bilirubin values \< 2 mg/dL; and
- Serum aspartate transaminase (ALT) and/or aspartate transaminase (AST) values\< 2.5 × the upper limit of normal (ULN) of the institutional laboratory reference range. Patients with elevated bilirubin due to Gilbert's...
- 6\. Participants 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 regimen are...
- 7\. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart...
- 8\. Ability to understand and the willingness to sign a written informed consent document.
What rules you out
- 1\. Patients with active plasma cell leukemia, POEMS syndrome, or amyloidosis are excluded from this trial.
- 2\. Stem cell transplant within 12 weeks prior to enrollment, or active GVHD.
- 3\. Ongoing Grade ≥2 peripheral sensory or motor neuropathy.
- 4\. History of any grade peripheral sensory or motor neuropathy with prior BCMA directed therapy. History of GBS or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.
- 5\. Previous treatment with an anti-BCMA bispecific T cell engager. --a. Prior treatment with anti-BCMA CAR-T and/or ADC therapy is permitted; however, the participant cannot be refractory to this therapy if it was...
- 6\. Participants who are receiving any investigational agents currently.
- 7\. Participants who have had myeloma therapy or investigational drug within 2 weeks prior to start of treatment or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier.
- 8\. Known or suspected hypersensitivity to the study drug or any components of the device (e.g. adhesive which contains acrylic).
- 9\. Impaired cardiovascular function or clinically significant cardiovascular diseases, defined as any of the following within 6 months prior to enrollment:
- a. Acute myocardial infarction, acute coronary syndromes (e.g., unstable angina, coronary artery bypass graft, coronary angioplasty or stenting, pericardial effusion);
- b. Clinically significant cardiac arrhythmias (e.g., uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia);
- c. Thromboembolic or cerebrovascular events (e.g., transient ischemic attack, cerebrovascular accident, deep vein thrombosis [unless associated with a central venous access complication] or pulmonary embolism);
- 10\. Participants with known active HBV, HCV, HIV, or any active, uncontrolled bacterial, fungal, or viral infection. Active infections must be resolved at least 14 days prior to enrollment. Per institutional protocol...
- 11\. Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ and or other cancers treated with curative intent.
- 12\. Other surgical (including major surgery within past 14 days prior to enrollment) medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory...
- 13\. Live attenuated vaccine within 30 days of the first dose of study intervention.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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 Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
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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.