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Multiple Myeloma clinical trials

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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: NCT03848845 Not yet recruiting - Multiple Myeloma Clinical Trials

Study Evaluating Safety, Tolerability and Clinical Activity of GSK2857916 in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Multiple Myeloma (RRMM)

DREAMM 4
Start date: March 13, 2019
Phase: Phase 2
Study type: Interventional

This is a phase I/II, single arm, open label, two-part study that will assess safety, tolerability and clinical activity of GSK2857916 given in combination with a programmed cell death-1 (PD-1) inhibitor pembrolizumab in subjects with RRMM. This study will enroll adult subjects with RRMM, who have undergone stem cell transplant or who are considered transplant ineligible. Part 1 is a dose escalation phase to evaluate the safety and tolerability of escalating doses of GSK2857916 in combination with 200 milligrams (mg) pembrolizumab to establish the recommended phase 2 dose (RP2D). The following dose levels of GSK2857916 are planned to be studied: 2.5 milligrams per kilograms (mg/kg) (dose level [DL] 1) and 3.4 mg/kg (DL2). Part 2 is a dose expansion cohort. Once the RP2D has been identified, an expansion cohort will open for enrolment to confirm the safety profile and to evaluate the clinical activity of the combination. Up to 40 evaluable subjects will be enrolled in this two-part study (up to 12 in Part 1, and 28 in Part 2).

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: NCT03844048 Not yet recruiting - Cancer Clinical Trials

An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial

Start date: April 15, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this extension study is to provide venetoclax and obtain long-term safety data for subjects who continue to tolerate and derive benefit from receiving venetoclax in ongoing studies.

NCT ID: NCT03841565 Withdrawn - Clinical trials for Recurrent Plasma Cell Myeloma

Daratumumab and Dexamethasone With Pomalidomide or Carfilzomib in Treating Patients With Relapsed Multiple Myeloma

Start date: March 31, 2019
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well daratumumab and dexamethasone with pomalidomide or carfilzomib work in treating patients with multiple myeloma that has come back. Immunotherapy with daratumumab may induce changes in body?s immune system and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as pomalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving daratumumab and dexamethasone with pomalidomide or carfilzomib work better in treating patients with multiple myeloma.

NCT ID: NCT03839459 Not yet recruiting - Clinical trials for Smoldering Multiple Myeloma

Denosumab for Smoldering Multiple Myeloma

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

This study will assess the safety and tolerability of denosumab in smoldering multiple myeloma subjects as well to see if denosumab can reduce subjects' risk of getting multiple myeloma.

NCT ID: NCT03837509 Not yet recruiting - Clinical trials for Relapsed or Refractory Multiple Myeloma

INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Relapsed or Refractory Multiple Myeloma

Start date: June 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and antitumor activity of INCB001158 in combination with daratumumab, compared with daratumumab alone, in participants with relapsed or refractory multiple myeloma who have received at least 2 but not more than 5 prior lines of therapy.

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: NCT03836014 Not yet recruiting - Clinical trials for Multiple Myeloma in Relapse

Study Comparing Continuous Versus Fixed Duration Therapy With Daratumumab, Lenalidomide, and Dexamethasone for Relapsed Multiple Myeloma

CONFIRM
Start date: March 2019
Phase: Phase 3
Study type: Interventional

The incorporation of proteasome inhibitors and immunomodulatory drugs into the standard of care has improved the outcome for patients with multiple myeloma (MM) over the past 10 years. However, most patients (>85%) still eventually relapse around 3-4 years after diagnosis, and ultimately die of their disease, despite salvage therapies. Relapse can occur even when complete remission is achieved after first-line therapy. Currently, daratumumab (Dara) is approved by the american FDA and EMA in combination with lenalidomide (Len) and dexamethasone (Dex) or bortezomib and Dex for the treatment of MM patients who have received at least one prior therapy. Therefore, the Dara-Len-Dex combination is likely to become the most widely used standard of care regimen for MM at the time of first relapse. However, although approval of the latter combination is meant for until disease progression (PD) ("continuous therapy") (CT), the actual optimal duration of relapse treatment is still unknown. Of note, many experts advocate that a "fixed duration" of therapy should be favored, especially if one can show that CT does not translate into a significant overall survival (OS) benefit. As a matter of fact, given the extremely high cost of such novel agents (>100 KEuros/year/patient), the pharmacoeconomic consequences of a "continuous" versus "fixed" duration therapy are also of utmost importance. Based on this background, the investigator propose to conduct a non-inferiority phase III randomized, multicenter, open label trial for treatment of MM at first relapse, comparing the Dara-Len-Dex combination administered continuously until PD, versus a fixed duration of 24 months. The choice of this duration is justified by the currently available evidence with respect to achievement of a plateau in terms of deep disease response, patients' compliance, and physicians' preference according to different surveys. The primary objective of this study is to estimate the OS rate at 4 years after diagnosis of relapse and initiation of salvage therapy. The primary endpoint is OS at 4 years after randomization. The analysis will be performed on both per-protocol and intent-to-treat sets of patients.

NCT ID: NCT03832127 Not yet recruiting - Myeloma Clinical Trials

Evaluation of PET 18F-Fludarabine for the Initial Assessment and End-treatment of Symptomatic Multiple Myeloma Patients

Myelofludate
Start date: April 1, 2019
Phase: Phase 1
Study type: Interventional

The objective of this exploratory study is to evaluate, for the first time, the sensitivity of 18F-Fludarabine to the initial diagnosis of MM compared to FDG-PET and MRI. The interest of this molecule will also be investigated as part of the end-of-treatment therapeutic evaluation.