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Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the safety and change in disease activity of ABBV-453 in adult participants with relapsed/refractory (R/R) MM. Adverse events and change in disease activity will be assessed. ABBV-453 is an investigational drug being developed for the treatment of R/R MM. In Substudy 1 there will be a dose escalation phase where participants will receive various doses of ABBV-453 in combination with daratumumab + dexamethasone, to determine the best dose of ABBV-453. This will be followed by a dose expansion and selection phase where participants will receive 1 of 2 doses of ABBV-453 in combination with daratumumab + dexamethasone, or daratumumab + dexamethasone + pomalidomide (only during the expansion phase). In Substudy 2, there will be a dose escalation phase where participants will receive various doses of ABBV-453 alone. Approximately 130 adult participants with R/R MM will be enrolled in the study in approximately 40 sites worldwide. In Substudy 1 escalation phase, participants will receive oral ABBV-453 tablets in combination with subcutaneous (SC) daratumumab injections + oral dexamethasone tablets and in the expansion phase, will receive oral ABBV-453 tablets in combination with SC daratumumab injections + oral dexamethasone tablets or daratumumab injections + oral pomalidomide + oral dexamethasone tablets. In Substudy 2, Japanese participants will receive oral ABBV-453 tablets. The total study duration is approximately 4.5 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution. The effect of the treatment will be frequently checked by medical assessments, blood tests, and side effects.
This research is being done to determine if the combination of the Dendritic Cell (DC)/ Multiple Myeloma (MM) fusion vaccine with elranatamab is safe and effective in treating Relapsed or Refractory Multiple Myeloma (MM). The names of the study drugs and vaccine involved in this study are: * DC/MM fusion vaccine (a personalized cancer vaccine in which harvested participant tumor cells are fused with harvested participant dendritic blood cells) * Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) (a type of growth factor) * Elranatamab (a type of T-cell engager antibody)
Treatment for relapsed/refractory multiple myeloma continues to evolve with the approval of highly effective anti-BCMA CAR T therapies in recent years. However, despite the high prevalence of renal insufficiency in this population, pivotal clinical trials have excluded patients with impaired renal function, leading to an urgent, unmet clinical need to develop safe and effective lymphodepleting regimens prior to CAR T administration for this population. In addition, renal insufficiency is linked to poor disease-related outcomes and is highly associated with several underserved populations. This study is testing the hypotheses that: 1. low-dose total body irradiation (TBI) in combination with cyclophosphamide (Cy) as lymphodepletion prior to administration of cilta-cel will be safe and tolerable in patients with multiple myeloma who have impaired renal function 2. low-dose TBI-Cy as lymphodepletion prior to cilta-cel will result in comparable CAR T expansion/persistence and disease response rates as those seen with standard lymphodepleting chemotherapy (fludarabine / cyclophosphamide).
The purpose of this study is to learn about the study medicine called elranatamab.This study aims to compare elranatamab to other medicines for the treatment of MM (a type of cancer). This study is seeking participants who: * Are 18 years of age or older and have MM. * Have received treatments before for MM. * Have MM that has returned or not responded to their most recent treatment. Half of the participants will receive elranatamab. The other half of participants will receive a combination therapy selected by the study doctor. The selected combination therapy will include 2 to 3 different medicines commonly used to treat MM. Elranatamab will be given as a shot under the skin at the study clinic about once a week. This may change to a smaller number of shots later in the study. The medicines in the combination therapy will be taken by mouth (at home or at the study clinic) AND will be given either as: * a shot under the skin at the study clinic * through a needle in the vein at the study clinic The number of times these medicines will be taken depends on what combination therapy the study doctor selects. Participants may continue to receive elranatamab or a combination therapy until their MM is no longer responding. The study team will see how each participant is doing with the study treatment during regular visits at the study clinic. The study team will continue to follow-up with participants after study treatment with telephone contacts (or visits). The study will compare the experiences of people receiving elranatamab to those people receiving a combination therapy. This will help learn about the safety and how effective elranatamab is.
Primary Objective • Assess the safety and tolerability of low-dose lenalidomide administered by continuous subcutaneous (SC) infusion (STAR-LLD) in combination with dexamethasone and a proteasome inhibitor (PI). Secondary Objectives * • To establish the pharmacokinetic (PK) profile of STAR-LLD at a defined infusion rate targeting steady-state blood concentrations. * • Evaluate changes in efficacy indicators including objective response rate (ORR), progression-free survival (PFS), and duration of response (DOR). Exploratory Objective * To assess the impact of STAR-LLD on patient reported symptoms and outcomes. Primary Endpoints * The grade, frequency, and relationship of treatment-emergent adverse events (TEAEs) including adverse events of special interest (AESIs): (gastrointestinal \[GI\] toxicity, fatigue, hematologic toxicity, rash (non-infusion site). * The observation of dose-limiting toxicities (DLTs) of STAR-LLD during Cycle 1. Secondary Endpoints •• Blood concentrations of lenalidomide at on Day 1 and at steady state. * Changes in biomarkers during treatment. * Rate of complete response, very good partial response (VGPR), partial response (PR), stable disease (SD), and progressive disease. * Determination of ORR, PFS, and DOR
This is a post-trial access (PTA) open-label, single-arm study in Multiple Myeloma participants who continue to derive clinical benefit from elranatamab monotherapy in the Pfizer-sponsored elranatamab Parent Studies.
A randomized placebo controlled, phase 2 study of budesonide in subjects with multiple myeloma undergoing autologous stem cell transplant (ACST). The study includes a run-in period with 20 patients.
The key aim of the study is to define the two biologically and clinically distinct entities: progressive versus stable myeloma precursor conditions.
This is an open-label, multi-site, Phase II randomized trial with response-adaptive design for newly diagnosed multiple myeloma (NDMM) participants who have had prior induction therapy. The primary objective of this study is to compare the rates of achieving undetectable measurable residual disease (MRD) in the bone marrow with elranatamab and daratumumab employed as post-induction consolidation and maintenance treatment (Arm A) versus autologous stem cell transplant (ASCT) followed by lenalidomide and daratumumab treatment (Arm B).
This is an open-label study of the safety, biodynamics, and anti-cancer activity of SENTI-202 (an off-the-shelf logic gated CAR NK cell therapy) in patients with CD33 and/or FLT3 expressing blood cancers, including AML and MDS.