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Multiple Myeloma clinical trials

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NCT ID: NCT03710915 Active, not recruiting - Multiple Myeloma Clinical Trials

A Study of HG146 Capsule in Chinese Subjects With Relapsed and Refractory Multiple Myeloma

Start date: August 11, 2018
Phase: Phase 1
Study type: Interventional

This study is designed to evaluate the tolerability and safety of HG146 capsule in patients with multiple myeloma.

NCT ID: NCT03687125 Active, not recruiting - Clinical trials for Multiple Myeloma in Relapse

Tinostamustine Conditioning and Autologous Stem Cell

TITANIUM1
Start date: September 19, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Phase 1 The primary objectives of Phase 1 of this study are to: Establish the safety, toxicity, and maximum tolerated dose (MTD) of the tinostamustine conditioning regimen. Identify the recommended Phase 2 dose (RP2D) of tinostamustine for use in the Phase 2 portion of the study. The secondary objective of Phase 1 of this study is to: Investigate the pharmacokinetics (PK) of tinostamustine.

NCT ID: NCT03674463 Active, not recruiting - Clinical trials for Refractory or Relapsed Multiple Myeloma

LCAR-B4822M-02 Cells in Treating Relapsed/Refractory (R/R) Multiple Myeloma

Start date: July 26, 2018
Phase: Phase 1
Study type: Interventional

This is a single arm, open-label, phase 1 study, to determine the safety and efficacy of LCAR-B4822M CAR-T cells in treating patients diagnosed with refractory/relapsed multiple myeloma (r/r MM).

NCT ID: NCT03672253 Active, not recruiting - Multiple Myeloma Clinical Trials

CAR-T Re-treatment for Refractory/Relapsed Multiple Myeloma

Start date: July 26, 2018
Phase: Phase 1
Study type: Interventional

This is a single arm, open-label, single-center, phase 1 study, to determine the safety and efficacy of autologous reinfusion of CAR-T cells targeting BCMA in the treatment of refractory/relapsed multiple myeloma (r/r MM) who get recurrence and progression after previous CAR-T cell therapy.

NCT ID: NCT03631043 Active, not recruiting - Clinical trials for Smoldering Plasma Cell Myeloma

Personalized Vaccine in Treating Participants With Smoldering Multiple Myeloma

Start date: December 21, 2018
Phase: Early Phase 1
Study type: Interventional

This early phase I trial studies the side effects of personalized vaccine in treating participants with smoldering multiple myeloma. Vaccines made from a person's blood and bone marrow may help the body build an effective immune response to kill cancer cells.

NCT ID: NCT03493737 Active, not recruiting - Multiple Myeloma Clinical Trials

Cost-Utility Analysis Hospital Versus Home in Multiple Myeloma

ADHOMY
Start date: April 10, 2018
Phase:
Study type: Observational

Bortezomib needs repetitive visits at hospital for injections. Hospital-at-Home (HaH) might be an attractive and suitable alternative in this situation. This study aim to perform a cost-utility analysis of two different strategies in several HaH structures within the Grand Est region in France.

NCT ID: NCT03486067 Active, not recruiting - Multiple Myeloma Clinical Trials

Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Subjects With Relapsed and Refractory Multiple Myeloma

Start date: April 3, 2018
Phase: Phase 1
Study type: Interventional

Study CC-93269-MM-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Part B), first-in-human clinical study of CC-93269 in subjects with relapsed and refractory multiple myeloma.

NCT ID: NCT03440411 Active, not recruiting - Multiple Myeloma Clinical Trials

Pom-dex Versus Pom-Cyclo-dex in MM Patients With Biochemical or Clinical Relapse, During Lena Maintenance Treatment

PO-3887
Start date: February 18, 2016
Phase: Phase 3
Study type: Interventional

The combination lenalidomide plus low-dose dexamethasone (Rd) is an active treatment for Multiple Myeloma (MM) patients, both at diagnosis and at relapse. Pomalidomide, is an immunomodulatory molecule (IMID), derivative of thalidomide, developed to improve the efficacy and reduce the toxicity of the parent molecule. Pomalidomide and dexamethasone (pom-dex) proved to be an effective and safe treatment in MM patients refractory to lenalidomide and refractory/intolerant to bortezomib. The addition of chemotherapy to novel drugs has been evaluated both at diagnosis and at relapse. The combination of pomalidomide-cyclophosphamide-prednisone proved to be safe and effective in relapsed/refractory MM patients. The combination pomalidomide-cyclophosphamide-dexamethasone (pom-cyclo-dex) was tested in a phase II study in patients with relapsed and refractory MM, demonstrating a good tolerability using pomalidomide at the dose of 4 mg. Pom-cyclo-dex resulted in a superior response rate and PFS compared to pom-dex. The increased hematologic toxicities, as a result of the addition of oral cyclophosphamide, were manageable. With an overall response rate of 65% the combination demonstrated a promising efficacy.The first aim of our trial, is to compare the combination of pom-cyclo-dex vs pom-dex. Relapsed myeloma is defined as previously treated myeloma that progresses and requires the initiation of salvage therapy. According to IMWG recommendation, biochemical relapse is defined as an increase of ≥ 25% of tumor burden from lowest value, without any CRAB feature (CRAB is defined as the onset of clinical symptoms: hypercalcemia, renal failure, anemia and bone lesions) and detected in 2 consecutive determinations. Clinical relapse requires one or more direct indicators of progressive disease and end organ dysfunction (CRAB features). Treatment at relapse should start in case of clinical relapse or a significant paraprotein increase (doubling of M-component in 2 months). In case of biochemical relapse the standard is observation only, as in case of asymptomatic MM at diagnosis. However, a recently published trial, showed improved PFS and OS for newly diagnosed asymptomatic patients treated with lenalidomide and dexamethasone in comparison with observation only. Our hypothesis is that similarly, in the relapse setting, patients may benefit from an early intervention, meaning a treatment at biochemical relapse and not only in case of clinical relapse or rapid increase of M-component.

NCT ID: NCT03409692 Active, not recruiting - Multiple Myeloma Clinical Trials

Validation of a Personalised Medicine Tool for Multiple Myeloma That Predicts Treatment Effectiveness in Patients

MMpredict
Start date: June 14, 2017
Phase:
Study type: Observational

The consortium aims to commercialise the MMpredictor as a personalised medicine tool that predicts the most effective treatment strategy for individual Multiple Myeloma (MM) patients. MM is the second most common form of blood cancer contributing to 15% of all blood cancers and ~1,5% and 2% of all cancer deaths annually in the EU and US, respectively. Patients show a large variability in treatment response and side effects due to tumour heterogeneity and the patient's intrinsic characteristics. Therefore, not every treatment will be suitable for each patient, and treatment strategies are often based on trial-and-error. The availability of multiple (>20) treatment options complicates treatment decision-making even more. With the current development of many more promising treatments, there is an urgent unmet clinical need for a diagnostic assay that supports personalised cancer treatment in order to improve patient health outcomes, prevent side effects and reduce healthcare costs. SkylineDx has previously developed the MMprofiler, a microarray-based diagnostic test that can subtype MM patients and reliably predict MM patient survival (prognosis). In this project, the test's clinical value will be expanded to include the prediction of treatment effectiveness in individual patients based on Gene Expression Profiling. An addendum for new intended use will be filed to the current in vitro diagnostic (IVD) registration, while renaming the test to MMpredictor. The project will also focus on positioning the test as a cost-effective IVD test for personalised medicine, that will increase health outcome and quality of life of patients and reduce healthcare costs. The consortium consists of a life science SME specialised in molecular diagnostics, clinical centres with world renowned KOLs, a leading health economic institute, and a European MM patient advocacy organisation combining all the required complementary expertise to successfully bring the MMpredictor to market.

NCT ID: NCT03357952 Active, not recruiting - Multiple Myeloma Clinical Trials

A Study of JNJ-63723283, an Anti-programmed Death-1 Monoclonal Antibody, Administered in Combination With Daratumumab, Compared With Daratumumab Alone in Participants With Relapsed or Refractory Multiple Myeloma

Start date: November 16, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

The main purpose of this study is to assess the safety of the combination of JNJ-63723283 and daratumumab (Part 1); to compare the overall response rate (ORR) in participants treated with JNJ-63723283 in combination with daratumumab versus daratumumab alone (Part 2); and to compare progression-free survival (PFS) in participants treated with JNJ-63723283 in combination with daratumumab versus daratumumab alone (Part 3).