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โ† Trials
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IMMUNOPLANT for Newly Diagnosed Multiple Myeloma

RecruitingPhase 2Ages 18 Years - anyAllDickran Kazandjian, MD
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to determine whether Linvoseltamab therapy in patients with newly diagnosed multiple myeloma will convert the disease status from minimal residual disease (MRD)-positive to MRD-negative, and increase the length of time that the disease is controlled. The researchers also want to find out the effects (good and bad) that Linvoseltamab has on participants and the condition.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Diagnosis of newly-diagnosed multiple myeloma (NDMM) per International Myeloma Working Group (IMWG) criteria documented initially prior to induction treatment. 2. Documentation of having received a triplet or quadruplet based initial combination therapy containing at least two of the following: Immunomodulatory drug (IMiD), proteosome inhibitor (PI), and/or anti-cluster of differentiation 38 (anti-CD38). 3. Documentation of attaining a best response of partial response (PR) or better but MRD+ (sensitivity: โ‰ค10\^-5) after at least 4 cycles of combination therapy. Note: Patients who at baseline prior to initial combination therapy did not have IMWG evaluable disease and therefore a response assessment of VGPR was unable to be made but currently have residual MM by M-protein and/or involved light chains and/or MRD positivity may enroll. Also, patients who have no apparent bone marrow (BM) residual disease but rather extramedullary disease as evidenced by positron emission tomography (PET)/computed tomography (CT) may enroll. 4. Age โ‰ฅ18 years. 5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) โ‰ค 1. Patients with ECOG 2 solely due to local symptoms of myeloma (eg, pain) may be allowed after discussion with the PI (APPENDIX A). 6. Adequate organ function, which is defined as follows: * a. Absolute neutrophil count (ANC) โ‰ฅ1,000 cells/microliter (mcL) (unless patient has ethnic/cyclic neutropenia or if neutropenia is thought to be due to MM) * b. Platelets โ‰ฅ50,000 platelets/mcL * c. Hemoglobin โ‰ฅ8 g/dL (transfusions permitted) * d. Serum total bilirubin โ‰ค 1.5 X upper limit of normal (ULN) or direct bilirubin โ‰ค ULN for patients with total bilirubin levels \> 1.5 ULN (except patients with Gilbert's syndrome who must have a total bilirubin of \<3 X ULN) * e. Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)) and alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (SGPT)) โ‰ค 2.5 X ULN * f. Serum creatinine โ‰ค 1.5 X ULN (except if due to myeloma) or estimated glomerular filtration rate (eGFR) โ‰ฅ30 mL/min/1.73 m2 (note that measured glomerular filtration rate \[GFR\], ie, 24-hour urine, can also be used) based on institutional standard * g. Female patients of childbearing potential must have a negative serum pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 6 months following the last dose of study treatment. For more information on contraception requirements, please refer to Section 4.11. * h. Willing and able to provide written informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure. For more information on the informed consent process, please refer to Section 15.1. 7. Willing and able to comply with clinic visits and study-related procedures. Exclusion Criteria: 1. Patients who have received prior systemic therapies for MM other than initial IMiD/PI/anti-CD38-based combination therapy (receiving limited cycles of other induction therapies, eg, cyclophosphamide, bortezomib and dexamethasone (CyBorD) or pulse dexamethasone prior to main induction is allowed). Exclusions include high-dose melphalan with autologous stem cell transplant (HDM-ASCT) and allogeneic stem cell transplant (SCT). Note: Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent within 72 hours of start of study drug is not permitted. 2. Patients who are receiving any other investigational agents for any reasons. 3. Patients who receive a live attenuated vaccine within 4 weeks of scheduled study treatment administration. 4. Contraindication to any concomitant medication, including those medications administered for infusion reaction, antiviral, antibacterial, anticoagulation, tumor lysis, or hydration prophylaxis given prior to therapy (Sections 4.8, 4.9, and 7). 5. Patient has any of the following: 1. Human immunodeficiency virus (HIV)-positive with 1 or more of the following: * i. History of acquired immune deficiency syndrome (AIDS)-defining conditions cluster of differentiation 4 (CD4) count \<350 cells/mm3 * ii. Detectable viral load during screening or within 6 months prior to screening * iii. Not receiving highly active anti-retroviral therapy * iv. Had a change in anti-retroviral therapy within 6 months of the start of screening * v. Receiving anti-retroviral therapy that may interfere with study treatment as assessed after discussion with the Sponsor-Investigator in consultation with study pharmacist 2. Hepatitis B infection (ie, hepatitis B surface antigen (HBsAg) or hepatitis B virus (HBV)-deoxyribonucleic acid \[DNA\] positive). Patients with resolved infection (ie, patients who are HBsAg negative but positive for antibodies to hepatitis B core antigen (anti-HBc) and/or antibodies to hepatitis B surface antigen (anti-HBs)) must be screened using real-time polymerase chain reaction (PCR) measurement of HBV DNA levels. Those who are PCR positive will be excluded. In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection status. EXCEPTION: Patients with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination do not need to be tested for HBV DNA by PCR. 3. 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 history of chronic hepatitis C infection (defined as both HCV antibody and HCV RNA positive) completed an
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What it tests

  • Linvoseltamab
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Where

1 site
University of Miami
Miami, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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