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Neoplasms, Plasma Cell clinical trials

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NCT ID: NCT06171685 Not yet recruiting - Clinical trials for Refractory Multiple Myeloma

Horizon Adaptive Platform Trial Evaluating Therapies in RRMM

Start date: July 31, 2024
Phase: Phase 2
Study type: Interventional

This trial is an adaptive platform trial. The structure of the protocol allows the trial to evolve over time. Multiple investigational arms will be included within the trial under a Master Protocol (MP). These investigational arms may be added as appendices at different times depending on whether they are trial-ready and whether accrual in the trial will support another arm. Accrual to an arm will terminate in accord with the arm's appendix to the Master Protocol. The purpose of this proposed structure is to support the recurrent research challenge of efficiently evaluating what is the best therapy for a particular patient.

NCT ID: NCT06145581 Not yet recruiting - Multiple Myeloma Clinical Trials

Remote Monitoring With Health-Coaching to Improve Quality of Life in Older Patients With Multiple Myeloma

Start date: June 2024
Phase: N/A
Study type: Interventional

This clinical trial tests the effectiveness of a home-based mindfulness physical activity program with remote monitoring combined with structured telephone-based health coaching to decrease fatigue and improve quality of life in older patients with multiple myeloma (MM). Studies have shown that MM patients have the highest symptom burden among all blood cancers, with older patients experiencing more symptoms and problems, such as fatigue and decreased quality of life, compared to younger patients. There is some data to support that physical activity may have beneficial effects on fatigue, physical function, and quality of life in older cancer patients. Studies have also shown that older patients prefer activities that are gentle, holistic, and home-based. Mindfulness-based interventions have been shown to have positive effects on sleep, depression, anxiety and cancer-related fatigue. Health coaching is a patient centered behavioral change intervention that is delivered by various healthcare professionals and involves goal-setting, self-discovery, and accountability. Health coaching interventions have been shown to increase physical activity levels and improve quality of life. A home-based mindfulness physical activity program with remote monitoring combined with structured telephone-based health coaching may decrease fatigue and improve the quality of life in older patients with MM.

NCT ID: NCT06142396 Not yet recruiting - Multiple Myeloma Clinical Trials

Pilot Study Dara-CyBorD in Newly Diagnosed Multiple Myeloma Patients With Renal Failure

Start date: January 1, 2024
Phase: Early Phase 1
Study type: Interventional

The goal of this study is to assess the efficacy of induction treatment with daratumumab-hyaluronidase (dara SC) with cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) for four cycles in patients with newly diagnosed multiple myeloma who have new onset renal failure. This study will also investigate the difference responses in African American (AA) patients versus non-African American patients. The primary questions this study aims to answer are: 1. To evaluate the very good partial response rate (VGPR) after 4 cycles of Dara-CyBord. 2. To evaluate the renal response rate (RRR) after 4 cycles of Dara-CyBord.

NCT ID: NCT06140524 Not yet recruiting - Clinical trials for Smoldering Multiple Myeloma (SMM)

A Proof-of-Concept Study to Learn Whether Linvoseltamab Can Eliminate Abnormal Plasma Cells That May Lead to Multiple Myeloma in Adult Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma

LINKER-MGUS1
Start date: July 15, 2024
Phase: Phase 2
Study type: Interventional

The primary purpose of the study is to understand how well the study drug can eliminate abnormal plasma cells and laboratory signs of high-risk monoclonal gammopathy of undetermined significance (HR-MGUS) and non high-risk smoldering multiple myeloma (NHR-SMM). This requires understanding the safety and tolerability of the study drug (how the body reacts to linvoseltamab) as well as the effectiveness of the study drug (how well linvoseltamab eliminates plasma cells). All participants will start treatment with gradually increasing doses of linvoseltamab (step-up doses) before they start receiving the assigned full dose. The study is split into 2 parts: - In Part 1, separate groups of 3-6 patients will receive different full doses of linvoseltamab to evaluate the short-term side effects (safety) and tolerability of the study drug within the first 5 weeks after starting treatment. The data collected will help to make a decision about the dosing regimens chosen for Part 2. - In Part 2, a larger number of participants will be randomized to different dosing regimens to further assess the side effects of linvoseltamab, and to evaluate the ability of linvoseltamab to eliminate abnormal plasma cells in HR-MGUS and NHR-SMM. The study is looking at several other research questions, including: - How many participants treated with linvoseltamab have improvement of their HR-MGUS or NHR-SMM? - What side effects may happen from taking the study drug? - How much study drug is in the blood at different times? - Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects).

NCT ID: NCT06133426 Not yet recruiting - Clinical trials for Lymphoma, Non-Hodgkin

Evaluation of the Role of Connected Scales in the Therapeutic Care of Hematology Patients

BTP
Start date: May 2024
Phase: N/A
Study type: Interventional

In this research, we will evaluate the feasibility of following by remote monitoring, using a connected scale, in hematology patients suffering from myeloma or lymphoma and requiring treatment with chemotherapy. 30 patients will be included in the research and will all use a connected scale for the duration of their participation (7 weeks +/- 1 week). During their participation, patients will be asked to weigh themselves once a day, ideally at a set time. Patient data will be accessible by the medical team via a remote monitoring platform. Alerts will be generated in the event of abnormal development of certain clinical parameters (weight, heart rate, etc.) allowing early treatment to be implemented by the medical team. At the end of their participation, we will evaluate patients' support and perception of this tool, as well as the healthcare consequences of the alerts generated by the remote monitoring platform.

NCT ID: NCT06126237 Not yet recruiting - Multiple Myeloma Clinical Trials

A Study of CM313 in Subjects With Relapsed or Refractory Multiple Myeloma

Start date: February 28, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multi-center, open-label, Phase 1/2 study to evaluate the safety, tolerability, Pharmacokinetics, pharmacodynamics and Preliminary Efficacy of CM313 in Subjects with Relapsed or Refractory Multiple Myeloma.

NCT ID: NCT06116734 Not yet recruiting - Multiple Myeloma Clinical Trials

Lapelga vs Gastrofil

Start date: November 1, 2023
Phase: Phase 3
Study type: Interventional

This study is examining one-time injection of biosimilar pegfilgrastim compared with multiple injection biosimilar filgrastim post autologous hematopoietic stem cell transplantation. Study aims to compare biosimilar pegfilgrastim - LaPelga and biosimilar filgrastim -Gastrofil to see if they are similar in efficacy in terms of neutrophil engraftment, limited adverse effects, and more convenience to our patients, with potential cost savings.

NCT ID: NCT06115135 Not yet recruiting - Clinical trials for Multiple Myeloma in Relapse

A Study of Venetoclax in Combination With Isatuximab and Dexamethasone for Relapsed/Refractory Multiple Myeloma

Start date: March 1, 2024
Phase: Phase 2
Study type: Interventional

A phase 2 study of venetoclax in combination with isatuximab and dexamethasone for relapsed/refractory multiple myeloma patients with t(11;14)

NCT ID: NCT06109233 Not yet recruiting - Multiple Myeloma Clinical Trials

A Perspective Study of the MRD-tailored Therapy in Patients With Newly Diagnosed Multiple Myeloma With Persistent Minimal Residual Disease After Initial Treatment

MRD
Start date: June 10, 2024
Phase:
Study type: Observational

The aim of this study was to observe the rate of MRD conversion and the impact on survival in newly diagnosed multiple myeloma (NDMM) patients with persistent MRD positivity after induction and consolidation therapy (autologous hematopoietic stem cell transplantation or consolidation of the original regimen) who were switched to high-intensity therapy, and to compare the rate of persistent MRD-negativity, progression-free survival (PFS), and overall survival (OS) between the two groups in comparison with NDMM patients who achieved MRD-negativity after the same induction and consolidation therapy.

NCT ID: NCT06099912 Not yet recruiting - Multiple Myeloma Clinical Trials

Dynamic Frailty Assessment for Guiding the Treatment in Older Adults With Newly Diagnosed Multiple Myeloma

DFA
Start date: July 1, 2024
Phase:
Study type: Observational

Investigators designed the single-center, prospective real-world based clinical study with the aim of applying the standardized geriatric assessment system IMWG-FS internationally for dynamic frailty assessment of elderly newly diagnosed multiple myeloma(NDMM), guiding therapeutic decision based on their fit/frail status (fit → intensive; frail → mild), to observe their treatment tolerance, treatment related adverse events(TRAE), treatment discontinued(TD), and survival(progression survivaland overall survival).