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A First-in-human, Open-label, Phase 1 Study To Evaluate The Safety, Antitumor Activity, Pharmacokinetics, And Pharmacodynamics Of Subcutaneous SAR446523, An Anti-GPRC5D ADCC-enhanced Monoclonal Antibody, In Participants With Relapsed/Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ
Jacksonville, FL
Rochester, MN
This is a first-in-human study of SAR446523 conducted in patients with RRMM. The study consists of two parts: Dose escalation (Part A): In this part, up to 6 dose levels (DLs) of SAR446523 will be explored to determine the maximum administered dose (MAD), maximum tolerated dose (MTD), and recommended dose range (RDR) of 2 dose regimens which will be tested in the dose optimization part. Dose optimization (Part B): In this part, participants will be randomly assigned in a 1:1 ratio using interactive response technology (IRT) to either one of the chosen dose regimens of SAR446523 (determined from data coming from Part A), to determine the optimal dose as the recommended phase 2 dose (RP2D) of SAR446523.
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A Multi-center, Prospective, Longitudinal, Observational Study Focused On Obtaining And Storing Biospecimens From Multiple Myeloma In Various Stages Of Development, Before And After Treatment
Scottsdale/Phoenix, AZ
Rochester, MN
The purpose of this study is to enroll subjects with MM at defined stages of their disease course and at specified clinical milestones and collect biospecimens along with clinical data (including treatment). These data will be used to investigate the relationship between genomic, molecular and cellular features of tumor and immune microenvironments and their association with clinical and demographic variables.
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A Phase 3 Randomized Study Comparing JNJ-79635322 Versus Teclistamab In Participants With Relapsed Or Refractory Multiple Myeloma After 1 To 3 Prior Lines Of Therapy, Including An Anti-CD38 Antibody And Lenalidomide
Scottsdale/Phoenix, AZ
Jacksonville, FL
Rochester, MN
The purpose of this study is to evaluate how well JNJ-79635322 works when compared with teclistamab.
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A Phase II Randomized Study Comparing BTK Inhibitors (Ibrutinib Plus Rituximab Or Zanubrutinib Alone) Vs. BCL-2 Inhibitor (Venetoclax) And Rituximab In Previously Untreated Waldenströmâ??s Macroglobulinemia (WM) / Lymphoplasmacytic Lymphoma (LPL)
Jacksonville, FL
Rochester, MN
The purpose of this study is to evaluate the effects of ibrutinib and rituximab with or without venetoclax in treating patients with previously untreated Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving venetoclax with ibrutinib and rituximab with may work better in treating patients with previously untreated Waldenstrom's macroglobulinemia than ibrutinib and rituximab alone.
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Closed for Enrollment
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A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance To Lenalidomide Maintenance Therapy After Autologous Stem Cell Transplantation (ASCT) In Participants With Newly Diagnosed Multiple Myeloma (NDMM)
Jacksonville, FL
Rochester, MN
The purpose of this study is to compare the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM).
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An Open-label Phase I/II Trial Of Venetoclax-Dexamethasone In Relapsed And/or Refractory T(11;14) Systemic Light-Chain Amyloidosis
Rochester, MN
The purpose of this study is assess safety, safest dose, and effectiveness of venetoclax in combination with dexamethasone in participants with t(11;14) positive relapsed (comes back) or refractory (did not get better) light chain amyloidosis.
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