View clinical trials related to Multiple Myeloma.
Filter by:This is a phase I-II open-label, multicenter, non-randomized study aiming to evaluate the efficacy and safety of belantamab mafodotin in combination with carfilzomib (Kyprolis®) and dexamethasone (Kd). Since this is the first time that this combination is being evaluated in a clinical trial, a first dose escalation part will be developed following the classic 3+3 design, to establish the maximum tolerated dose (MTD) of the combination. Once the MTD will be defined, a dose expansion phase will be open to recruit up to 60 patients. Patients will receive treatment with belantamab-mafodotin + Kd, until unacceptable toxicity, disease progression, patient withdrawal, loss to follow-up, end of study, or death.
This is a single-center, single arm, phase I study designed to determine the safety and find the recommended Phase 2 dose (RP2D) or maximum dose level (MTD) of Belantamab Mafodotin in patients with high-risk smoldering multiple myeloma. The study will have a dose-finding part and a dose-expansion part. The maximum number of enrolled patients will be 30 with 18 patients for the dose-finding part and 12 patients for the dose-expansion part. Once we determine the MTD or RP2D in the dose-finding part, we will enroll and treat 12 additional patients at the MTD or RP2D in the expansion part. Efficacy will be assessed through the overall response rate (ORR) at the end of the study. With the limited number of patients for the dose-expansion part, we will not have formal futility monitoring rule.
This descriptive study aims to evaluate the experience of adults with relapsed or refractory multiple myeloma receiving standard of care isatuximab-irfc through collection of quantitative, qualitative and wearable data. Fifty adults with relapsed or refractory multiple myeloma receiving standard of care isatuximab-irfc will be enrolled across 2 sites, The University of California San Francisco and The University of Texas MD Anderson Cancer Center. Consented participants will be enrolled in a 3-month digital health coaching program through which electronic patient reported outcomes and wearable activity data will be collected. Outcomes include treatment experience, quality of life, financial toxicity, treatment adherence, symptom burden and health self-efficacy. These will be captured by patient reported outcome measures including the Patient's Qualitative Assessment of Treatment- Real World (PQAT-RW), Patient Global Impression of Change/Severity (PGIC/S), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30), Quality of Life Questionnaire Multiple Myeloma (QLQ-MY20), and the European QoL-5 Dimensions (EQ5D), Cancer Behavior Inventory-Brief Form (CBI-B), Center for Adherence Support Evaluation (CASE) Medication Adherence Index, Comprehensive Score for Financial Toxicity (COST) Instrument. Clinical data, including treatment history, healthcare utilization, and co-morbidities, as well as demographic data will be collected via the electronic health record from each clinical site. This data will be complemented by qualitative data from a selected cohort of study participants with a focus on treatment experience ranging from infusion burden, toxicity management, to overall quality of life. Evaluation of this data in combination will be used to better understand the treatment experience of individuals on standard of care isatuximab-irfc specifically, and with relapsed or refractory multiple myeloma generally, contributing to an existing gap in the literature regarding patient reported outcomes from diverse data sources. Outcomes will be analyzed with attention to the relationship between social determinants of health, including race, ethnicity, and geographic location, and treatment experience as reflected in both the qualitative and quantitative data.
This study evaluates the risks and experience of blood clots and bleeding in patients with blood cancers. While it is standard of care to use medications to reduce the risk of blood clots in hospitalized individuals, some patients with blood cancers have low platelet counts that can increase the concern for bleeding complications associated with these medications. At this time, the optimal management strategies for blood clots are not well known for patients with blood cancers. This pilot study evaluates additional information that could help doctors know which patients are at highest risk for blood clots.
The purpose of this study is to evaluate the safety and efficacy of mitoxantrone hydrochloride liposome injection in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma.
The purpose of this study is to characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose(s) of talquetamab combination regimens.
Observational clinical trial recruiting Smouldering Myeloma patients (SMM) or potential SMM patients. Study involves collecting blood and bone marrow samples to determine the features of the tumour genome and BM microenvironment, including immune dysfunction that are key drivers of progression from precursor conditions (MGUS and SMM) to MM.
Since 2009, the Department of Clinical Haematology at Limoges University Hospital Centre, supported by the HEMATOLIM network, has been operating the regional "ESCADHEM" system: [Secure outsourcing of injectable chemotherapy to the home care setting for malignant blood diseases]. In addition to Limoges University Hospital, Brive Hospital and Guéret Hospital, this system involves four Hospital at Home (HAH) structures across the three départements of the former Limousin region. In this process, chemotherapy administered by subcutaneous injection is prescribed by a hospital physician in one of the hospitals "authorised to deliver cancer treatments" in the former region of Limousin: Limoges University Hospital Centre, Brive Hospital or Guéret Hospital. This chemotherapy is then prepared in one of the three hospital pharmacies authorised to perform centralised reconstitution, in accordance with current standards. The preparation is then transferred to one of the four Hospital at Home (HAH) structures, which transports the product to the patient's home where it is administered by the nurse (IDE). This last step in the process is under the responsibility of the HAH structure coordinating physician, who is also responsible for waste collection. Supported by its experience within the ESCADHEM system with subcutaneous drugs and in the context of the arrival of new intravenous drugs, in short infusion form, the Department of Clinical Haematology, supported by the HEMATOLIM network (which became the HEMATOLIM association on 1 January 2020) and the professionals involved began the process of outsourcing these drugs to the HAH setting. One of these drugs is carfilzomib, used to treat multiple myeloma, and its outsourcing to the HAH setting was put in place from the end of 2018. In parallel with this, the Department of Clinical Haematology would like to set up a study to evaluate the feasibility of outsourcing this new drug, administered intravenously, based on a model that we know to be operational and secure for chemotherapies administered by subcutaneous injection. the Department of Clinical Haematology hope to be able to confirm the value of caring for multiple myeloma patients in an HAH setting by improving their quality of life and optimising their care pathway in organisational and economic terms. the Department of Clinical Haematology hope to be able to demonstrate that this organisation is not only efficient in the view of patients, but also for the healthcare professionals working in the Hospital, the HAH structure and in the community, involved throughout the care process. To conduct our study, the Department of Clinical Haematology selected the novel drug carfilzomib, used in the treatment of multiple myeloma. The prescribing conditions, treatment administration regimen and outsourcing quality processes for this drug are available in the annexes. These standard regimens were constructed on the basis of the protocols in the ESCADHEM system, extensively trialled and validated by the HAS, for drugs injected subcutaneously and following a collegial approach. We thus hope to demonstrate that the protocols used for drugs administered by subcutaneous injection - in particular, bortezomib and azacytidine - are applicable to carfilzomib following minor modifications to the procedures given the IV administration of the latter drug as a short infusion. It should be noted that it is essential that the first cycle of carfilzomib be administered, in its entirety, in an outpatient clinic setting. Thereafter, if the patient is eligible for treatment in an HAH setting, the 1st day of each cycle will be performed in an outpatient clinic. Following this study, the Department of Clinical Haematology hope to be able to publish our research and promote it at national and/or international congresses. This research should further reinforce our already significant experience in this type of care strategy for malignant blood diseases in the HAH setting, which we believe is simultaneously innovative, practical and beneficial for all the players in the care pathway concerned. The model will probably be useful for outsourcing to the HAH setting other novel drugs progressively arriving on the market with profiles similar to that of the drug we wish to study. Finally, our project aims to demonstrate that our procedures for the secure outsourcing of carfilzomib to the HAH setting, in place since the end of 2018 are valid and could be extended to other regions of France. Furthermore, the current health landscape is undergoing profound changes associated with budget constraints, as well as societal and technological evolutions, with the result that home care, and hence HAH structures, appear, more than ever, to be the model of the future.
This phase II clinical trial evaluates whether a modified modality of conditioning reduces treatment-related mortality (TRM) in patients who undergo a hematopoietic stem cell transplant (HSCT) for a hematological malignancy. HSCT is a curative therapy for many hematopoietic malignancies, however this regimen results in higher rates of TRM than other forms of treatment. In recent years, less intense conditioning regimens with radiation and chemotherapy prior to HSCT have been developed. Radiation therapy uses high energy sources to kill cancer cells and shrink tumors while chemotherapy drugs like fludarabine and cyclophosphamide work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This study evaluates whether a two-step approach with lower-intensity regimens of these treatments prior to HSCT reduces the rate of TRM.
This phase 3 randomized, open-label multicenter trial will compare the efficacy, safety and the impact on health-related quality of life (HR-QoL) of SPd versus EloPd in pomalidomide-naïve patients with MM who have received 1 to 4 prior anti-MM regimens and been treated with an immunomodulatory imide drug (IMiD), proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody (mAb).