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Neoplasms, Plasma Cell clinical trials

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NCT ID: NCT05892393 Recruiting - Multiple Myeloma Clinical Trials

Imaging Study of [89Zr]DFO-YS5 for Detecting CD46 Positive Malignancy in Multiple Myeloma

Start date: June 16, 2023
Phase: Phase 1
Study type: Interventional

This phase I trial tests the safety of [89Zr]DFO-YS5 positron emission tomography (PET) imaging and how well it works to detect CD46 positive cancer cells in patients with multiple myeloma. [89Zr]DFO-YS5 is an imaging agent called a radiopharmaceutical tracer. A radiopharmaceutical tracer uses a small amount of radioactive material that is injected into a vein to help image different areas of the body. [89Zr]DFO-YS5 targets a specialized protein called CD46, which is in certain multiple myeloma cancer cells, and [89Zr]DFO-YS5 PET scans may improve detection of multiple myeloma.

NCT ID: NCT05889221 Active, not recruiting - Multiple Myeloma Clinical Trials

Multicenter Phase 2 Study of Subcutaneous Isatuximab Plus Bortezomib, Lenalidomide and Dexamethasone in the Treatment of Newly Diagnosed Transplant Ineligible Multiple Myeloma

Start date: October 23, 2023
Phase: N/A
Study type: Interventional

Isatuximab was developed on a sub-cutaneous (SC) administration format. SC administration is expected to be more convenient for the patient, with a much shorter duration of administration compared to the currently approved IV route. The SC Isatuximab RP2D fixed dose was determined at 1400 mg in a phase1b assessing SC Isatuximab in combination with pomalidomide and dexamethasone in RRMM patients. A similar activity and a favorable safety administration profile compared to the IV formulation, was shown in this trial, as expected (Moreau et al, ASH 2021; Quach et al, ASCO 2022). This data should be confirmed in the ongoing IRAKLIA/EFC15951 phase 3 study, that compared in the RRMM, isatuximab plus pomalidomide and dexamethasone IV versus SC. Whether isatuximab SC, fixed 1400 mg dose, will show similar efficacy and safety profile as to anti-CD38Rd+V remains to be demonstrated. The investigators have planned to study the combination of SC isatuximab plus VRd (IsVRd) in patients with NDMM NTE in a phase 2 study across IFM (Intergroupe Francophone du Myeloma) centers in France to compare indirectly this data to the data obtained from studies that have studied this association in that population with the IV isatuximab formulation.

NCT ID: NCT05888636 Recruiting - Multiple Myeloma Clinical Trials

Transcriptomics and Epigenetics Analysis in Drug-Resistance of Multiple Myeloma

TEDROMM
Start date: June 18, 2019
Phase:
Study type: Observational [Patient Registry]

Multiple Myeloma (MM) is the more common hematological neoplastic disease second only to Hodgkin lymphoma. In MM patients, mutated genes are mainly KRAS (23%), NRAS (20%), FAM46C (11%), DIS3 (11%) e TP53 (8%). Epigenetics studies suggested that Changes in histone modifications and DNA methylation pattern, as well as non-coding RNAs (miRNAs) expression are involved in MM development. In particular, it has been shown that the aberrant expression of different miRNAs could discriminate healthy from ill patients. Unfortunately, the main critical issue for an effective treatment of MM is the intrinsic or acquired resistance to pharmacological treatments, due also to a plasmacellular clonal heterogeneity. The prospective study will involve a patient cohort with MGUS, MM smouldering and MM, with the aim to characterize different transcriptional and epigenetic features, also including miRNAs, among MM cells susceptible or resistant to conventional therapies. The final goal is to identify new prognostic and predictive biomarkers that could be used as therapeutic tools to improve clinical targeted therapies.

NCT ID: NCT05887206 Completed - Myeloma Multiple Clinical Trials

Corneal Toxicity in Patients Treated by Belantamab Mafodotin

Start date: May 2, 2022
Phase:
Study type: Observational

Belantamab Mafodotin is the first antibody conjugate targeting B-cell maturation antigen (BCMA) in relapsed or refractory multiple myeloma (RRMM). It is used in multiple myeloma refractory to an immunomodulatory drug or proteasome inhibitor and refractory and/or intolerant to an anti-CD38 monoclonal antibody. It has been found that the immunotherapy causes corneal side effects, Microcyst-like Epithelial Changes (MECs). They are round-shaped corneal inclusions that migrate from the peripheral cornea to the center, causing blurry vision, dryness and refractive shifts depending on their location and density.

NCT ID: NCT05880043 Recruiting - Clinical trials for Advanced Solid Tumors

A Study of GIC-102 (Allogeneic Natural Killer Cells) in Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma, and Multiple Myeloma

Start date: April 28, 2023
Phase: Phase 1
Study type: Interventional

This is a first-in-human trial to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor effects of GIC-102 in patients with advanced solid tumors, relapsed/refractory non-hodgkin lymphoma, and multiple myeloma.

NCT ID: NCT05879757 Recruiting - Multiple Myeloma Clinical Trials

Real-world Usage of HyQvia in Multiple Myeloma Adults With Secondary Immunodeficiency

Start date: October 17, 2023
Phase:
Study type: Observational

In this study, multiple myeloma participants with secondary immunodeficiency (SID) will be treated with HyQvia according to their clinic's standard practice. The study's main aim is to look into infusion parameters of HyQvia administration.

NCT ID: NCT05874193 Not yet recruiting - Clinical trials for Relapsed/Refractory Multiple Myeloma

A Collaborative Community Effort Using Belantamab Mafodotin in Relapsed/Refractory Myeloma

COSTA
Start date: June 2024
Phase: Phase 2
Study type: Interventional

This is a research study to find out if a drug called belantamab mafodotin in combination with dexamethasone, a steroid, can be safely and effectively given in the community setting. Belantamab mafodotin (BLENREP) was approved in the US in August 2020 under an FDA program called accelerated approval. In November 2022, belantamab mafodotin was removed from the market because a study to further confirm its activity in relapsed/refractory multiple myeloma did not deliver a supporting result. However, this confirmatory study demonstrated that some patients may still benefit from treatment with belantamab mafodotin, and that this benefit can be long lasting. Belantamab mafodotin is often given at large academic medical centers every 3 weeks. This study will assess whether it is possible to administer belantamab in the community setting every 6 weeks. It is unknown if administering belantamab every 6 weeks versus every 3 weeks will result in improved safety and/or reduced efficacy.

NCT ID: NCT05866757 Recruiting - Cancer Clinical Trials

Discontinuation Study

Start date: August 28, 2023
Phase: N/A
Study type: Interventional

An interventional, non-randomised study to assess the risk of progression after discontinuation of maintenance therapy in sustained MRD negative complete remission by flow cytometry MM patients without high-risk features who have completed at least two years of maintenance therapy or who have discontinued maintenance due to side effects. The primary endpoint is to assess the rates of sustained MRD negativity by NGF in the bone marrow at 12 months after discontinuation of maintenance therapy.

NCT ID: NCT05862012 Recruiting - Clinical trials for Relapsed/Refractory Multiple Myeloma

Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma

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

This study is a first-in-human, Phase 1, open-label study that will evaluate safety and anti-myeloma activity of ISB 2001 in participants with relapsed/refractory multiple myeloma (R/R MM).

NCT ID: NCT05860179 Not yet recruiting - Multiple Myeloma Clinical Trials

Examination of Trends in Multiple Myeloma Trial Patient Experiences

Start date: May 2024
Phase:
Study type: Observational

Historically, participation in clinical trials has been highly skewed towards specific demographic groups. However, research identifying which trial attributes impact participation, in either positive or negative ways, is limited. This study invites participants to record a wide range of data on their clinical trial experience, with the goal being to identify factors which persistently limit patients' ability to participate in, or complete, a trial in which they were initially interested. Data will be analyzed through a range of demographic lenses, in hopes of discovering patterns which might improve the experience of future multiple myeloma patients.