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Multiple Myeloma clinical trials

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NCT ID: NCT03875495 Recruiting - Multiple Myeloma Clinical Trials

A Phase I/II Study Evaluating Temferon in Multiple Myeloma Patients With Early Relapse After Front Line Therapy (TEM-MM)

Start date: March 6, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is a non-randomized, open label, phase I/II, dose-escalation study, involving a single injection of Temferon, an investigational advanced therapy consisting of autologous CD34+-enriched hematopoietic stem and progenitor cells exposed to transduction with a lentiviral vector driving myeloid-specific interferon-ɑ2 expression, which will be administered to up to 9 patients affected by multiple myeloma in early relapse after intensive front line treatment.

NCT ID: NCT03858205 Recruiting - Plasma Cell Myeloma Clinical Trials

Low-Dose Radiotherapy in Treating Painful Bone Metastases in Patients With Multiple Myeloma

Start date: March 11, 2019
Phase: N/A
Study type: Interventional

This phase II trial studies how well low-dose radiotherapy works in treating bone pain in patients with multiple myeloma that has spread to the bone. Radiation therapy uses high energy x-rays, gamma rays, neutrons, protons, or other sources to kill tumor cells and shrink tumors. Low-dose radiotherapy may be more convenient for patients and their families, may not interfere as much with the timing of chemotherapy, and may have less chance for short term or long-term side effects from the radiation.

NCT ID: NCT03852407 Recruiting - Multiple Myeloma Clinical Trials

Allogeneic Hematopoietic Cell Transplantation HLA-matched Donor After Flu-Mel vs Flu-Mel-ATG Conditioning

HLA
Start date: February 4, 2019
Phase: Phase 3
Study type: Interventional

The present project aims at comparing two conditioning regimens (Fludarabine-Melphalan (FM) vs Fludarabine-Melphalan-ATG (FM-ATG)). The hypothesis is that the FM-ATG regimen will be associated to better cGRFS.

NCT ID: NCT03850522 Recruiting - Clinical trials for Smoldering Multiple Myeloma

Phase IIa Trial of PD-L1 Peptide Vaccination as Monotherapy in High Risk Smoldering Multiple Myeloma

Start date: February 18, 2019
Phase: Phase 2
Study type: Interventional

This study is evaluating a new vaccine against PD-L1 as a possible treatment for high-risk smoldering multiple myeloma.

NCT ID: NCT03848676 Recruiting - Multiple Myeloma Clinical Trials

Genomic and Phenotypic Determinants of Resistance to Immunotherapies in Multiple Myeloma

Start date: July 1, 2018
Phase:
Study type: Observational

A total of 40 Multiple Myeloma (MM) patients at clinical relapse who progressed during Proteasome Inhibitors (PIs) or Immunomodulating Drugs (IMiDs)-based therapies and who are assigned to antiCD38-based salvage treatments, will be enrolled. We will collect bone marrow (BM) and peripheral blood (PB) samples from patients at specific timepoints: - baseline (BM, PB and buccal swab) - every 3 month (PB) - achievement of response (≥ Very Good Partial Response (VGPR)) (BM and PB) - relapse or refractory status to antiCD38-based treatments (BM and PB) Samples will be processed and stored in the "Hematological Laboratory" located in the University of Turin (Italy) for various proposed analyses: at specific time-points CD138+ (Plasma Cells-PCs) and marker CD138/19+ (B cells) will be immunomagnetically enriched from the BM mononuclear cells and frozen as viable cells in dimethyl sulfoxide (DMSO); PB mononuclear cells (PBMCs) will be isolated from whole blood by density-gradient centrifugation, and frozen as above; plasma fraction from PB and BM will be obtained by centrifugation and stored frozen; a buccal swab will be obtained at the time of enrollment as a source of control germline DNA and stored frozen.

NCT ID: NCT03836053 Recruiting - Clinical trials for Relapsed and/or Refractory Multiple Myeloma

Assessment of AMG 420 in Subjects With Relapsed and/or Refractory Multiple Myeloma

AMG420
Start date: March 6, 2019
Phase: Phase 1
Study type: Interventional

To confirm the maximum tolerated dose (MTD) from the BI 836909 trial of 400 mcg/d, given as 28-day continuous intravenous infusion in patients with relapsed and/or refractory multiple myeloma, to test the 600 mcg/d dose, given as a 28-day continuous iV infusion, and to expand on the dose determined as the Recommended Phase 2 Dose (RP2D).

NCT ID: NCT03829371 Recruiting - Multiple Myeloma Clinical Trials

STUDY COMPARING TWO STANDARD TREATMENTS IN AUTOLOGOUS STEM CELL TRANSPLANTATION INELIGIBLE POPULATION AFFECTED BY MULTIPLE MYELOMA

Start date: January 3, 2019
Phase: Phase 4
Study type: Interventional

Multiple myeloma (MM) is a neoplastic disease deriving from an abnormal proliferation of monoclonal plasma cells in the bone marrow. The survival of MM patients varies from less than 6 months to more than 10 years depending on the stage of disease at diagnosis and prognostic factors. Three current standard treatments are approved for elderly or younger patients with significant comorbidities not eligible for autologous stem cell transplantation (ASCT): bortezomib-melphalan-prednisone (VMP), melphalan-prednisone- thalidomide (MPT) and lenalidomide with low-dose dexamethasone (Rd). The consistent fraction of elderly patients with cancer and co-morbidities are at increased risk of developing frailty (the emergent geriatric syndrome), as well as physical and cognitive decline, with negative effect on nutrition and lifestyle, and eventually on responsiveness to and efficacy of treatments. A frailty scale was recently described that categorized patients with MM as fit, intermediate or frail based on age, comorbidities, and physical and cognitive functioning. The frailty score was a predictor of death, progression of the disease, toxicity and drug discontinuation. In this project, the investigators will compare available first line standard treatments, the triplet VMP versus the doublet Rd, in an unselected population of patients ≥ 65 years affected by MM in every day clinical practice. In the last decade, many novel and expensive drugs have been approved for this disease, yet the general older population is not adequately represented in validating trials. Nevertheless, the results and treatments derived from those trials have often been applied to the older population, with a high risk to produce a negative impact on patient functional capacity and ability to carry out daily tasks, cognitive function, depression status, nutritional condition, social situation/capability to stay at home and finally affecting their quality of life (QoL) and OS. The main aim of the project is to evaluate the best initial treatment for elderly MM patients and to compare benefits, risks, QoL and costs of currently available, standard treatments according to the frailty profile.

NCT ID: NCT03823534 Recruiting - Pain Clinical Trials

Post-Op Pain Control for Prophylactic Intramedullary Nailing.

Start date: February 20, 2019
Phase: Phase 3
Study type: Interventional

Nationally, the opioid crisis has become a major epidemic with increasing mortality rates each year. Orthopedic surgeons routinely prescribe narcotics instead of NSAIDs for post-op pain control because of risk of delayed healing and nonunion due to NSAID use. Orthopedic oncology, however, has a unique subset of patients that undergo prophylactic placement of intramedullary femoral nails. Because no fracture is present, these patients do not rely on inflammatory healing factors, allowing for post-op NSAID use. This study sets out to determine the effect of post-op toradol use in addition to opioids compared to solely opioids in patients undergoing prophylactic nailing of the femur.

NCT ID: NCT03807128 Recruiting - Multiple Myeloma Clinical Trials

MYeloma Resistance And Clonal Evolution

MYRACLE
Start date: February 11, 2019
Phase:
Study type: Observational [Patient Registry]

Multiple Myeloma (MM) is often associated with progression, temporary response to therapy and a high relapse rate over time resulting in a poor long-term prognosis. Because MM is classified as an incurable disease, therapeutic resistance is of great interest. However, knowledge about the biological mechanisms underlying resistance associated with MM therapies and about associated predictors remains poor. The MYRACLE cohort, a multicenter prospective cohort of patients with MM, is set up to address this limitation.

NCT ID: NCT03804424 Recruiting - Multiple Myeloma Clinical Trials

64Cu-LLP2A for Imaging Multiple Myeloma

Start date: November 20, 2018
Phase: Early Phase 1
Study type: Interventional

The investigators are performing a trial with goals to demonstrate the feasibility of imaging multiple myeloma (MM) patients with 64Cu-LLP2A-positron emission tomography (PET)/magnetic resonance (MR). The investigators suggest that 64Cu-LLP2A will allow for an accurate molecular imaging of MM lesions, which will have an important impact on early stage disease detection and in the long term on the initiation and choice of therapy in these patients.