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Neoplasms, Plasma Cell clinical trials

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NCT ID: NCT04150692 Withdrawn - Multiple Myeloma Clinical Trials

Escalation of Daratumumab Frequency Following Biochemical Progression in Relapsed/Refractory Multiple Myeloma

Start date: January 8, 2021
Phase: Phase 2
Study type: Interventional

In a small case series, the investigators identified five patients who had an initial response to standard daratumumab (weekly for 2 cycles, every other week for 4 cycles, then monthly thereafter) either as mono- or combination therapy, who then had daratumumab frequency escalated when early biochemical progression was noted, an investigational endeavor. In this series, patients received a median of 5 additional cycles of daratumumab at an escalated frequency (range: 2-8). Additionally, the median change in involved paraprotein after one cycle of weekly-escalated dara was -40% (range: -67% to +5%), with most achieving prior partial response or stable disease. In patients who initially have at least a partial response (PR) to daratumumab, who then have biochemical progression following de-escalation, it is conceivable that CD38 saturation is not optimized at the every 4 weeks dosing interval. The investigators believe that escalating the frequency of daratumumab in patients with biochemical progression, in this investigational setting, may recapture the initial response, delay clinical progression, and/or delay treatment changes.

NCT ID: NCT04024384 Withdrawn - Multiple Myeloma Clinical Trials

Daratumumab as Maintenance After Peripheral Blood Stem Cell Transplantation From HLA-identical or Haploidentical Family Donor in the Treatment of Refractory or Relapsed Multiple Myeloma: a Phase 2 Trial

DARALLO
Start date: July 2019
Phase: Phase 2
Study type: Interventional

The present protocol aims to test, whether an approach using (i) a reduced-toxicity TBF followed by a (ii) Daratumumab maintenance and (iii) prophylactic infusion of donor lymphocytes (pDLI), will be able to improve progression-free survival of patients with refractory or relapsed MM. This trial represents the first prospective protocol aiming to test the use of Daratumumab maintenance after HLA-identical or haploidentical allo-SCT in patients with MM.

NCT ID: NCT03983486 Withdrawn - Multiple Myeloma Clinical Trials

Rationale for Cytogenetic Risk Stratification by Imaging Flow Cytometry in Multiple Myeloma

CIF-PM
Start date: November 30, 2018
Phase:
Study type: Observational

A pioneer study demonstrated a proof of concept for IS-FISH with the new ISX technology. This state of the art technology has been recently acquired by the CHU of Amiens. In the present study the investigators want to establish a workflow for simultaneous immunostaining and characterization of FISH cytogenetic pathological signals with the imaging flow cytometer ISX, such as chromosomic gains, losses and translocations in multiple myeloma (MM). The gold standard technology for the detection of prognostic cytogenetic aberrations in MM is a FISH analysis after bone marrow (BM) plasma cells sorting (PCS).2,3 In MM, plasma cells isolation is usually based on CD38 and/or CD138 expression. Cytogenetic risk stratification is guided by the detection of 4 chromosomal aberrations: TP53 and CDKN2C deletions, CKS1B gains and t(4;14) translocation. Thanks to ISX technology the investigators may avoid cumbersome task of cell sorting (outsourced service for our hospital) meanwhile measuring precisely and qualitatively aberrant FISH signals on a large amount of cells.

NCT ID: NCT03952832 Withdrawn - Clinical trials for Smoldering Plasma Cell Myeloma

Leflunomide in Treating Patients With High-Risk Smoldering Multiple Myeloma

Start date: December 11, 2019
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well leflunomide works in treating patients with high-risk smoldering multiple myeloma. Leflunomide may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

NCT ID: NCT03856112 Withdrawn - Clinical trials for Recurrent Plasma Cell Myeloma

Ixazomib and Dexamethasone With or Without Venetoclax in Treating Patients With Non-t(11;14) Relapsed or Refractory Multiple Myeloma

Start date: June 21, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial studies the best dose and side effects of venetoclax and how well it works in combination with ixazomib and dexamethasone in treating patients with t(11;14) negative multiple myeloma that has come back or does not respond to treatment. Ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as venetoclax 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. It is not yet known how well venetoclax works with ixazomib and dexamethasone in treating patients with multiple myeloma.

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

Daratumumab, Pomalidomide, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma

Start date: August 7, 2020
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well daratumumab, pomalidomide, and dexamethasone work in treating patients with multiple myeloma that has come back (relapsed). 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. Giving daratumumab with dexamethasone and pomalidomide may work bettering in treating patient compared to dexamethasone and pomalidomide alone.

NCT ID: NCT03785184 Withdrawn - Multiple Myeloma Clinical Trials

A Study of Venetoclax Plus Lenalidomide and Dexamethasone for the Treatment of Newly Diagnosed t(11;14)-Positive Multiple Myeloma in Subjects Who Are Ineligible for High-Dose Therapy

Start date: April 29, 2019
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety and preliminary efficacy of venetoclax when combined with lenalidomide and dexamethasone for participants with newly diagnosed, active t(11;14) positive multiple myeloma (MM). This study will consist of 2 parts: Part 1 Dose Escalation and Part 2 Dose Expansion.

NCT ID: NCT03701321 Withdrawn - Clinical trials for Recurrent Plasma Cell Myeloma

Daratumumab, Bortezomib, and Dexamethasone With or Without Venetoclax in Treating Patients With Relapsed or Refractory Multiple Myeloma

Start date: January 25, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial studies the side effects and best dose of venetoclax when given together with daratumumab, bortezomib, and dexamethasone, and how well they work in treating patients with multiple myeloma that has come back (relapsed) or does not respond to treatment (refractory). Drugs used in chemotherapy, such as venetoclax and dexamethasone, 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. Immunotherapy with monoclonal antibodies, such as daratumumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving venetoclax with daratumumab, bortezomib, and dexamethasone may work better in treating patients with relapsed or refractory multiple myeloma compared to standard of care treatment, including chemotherapy.

NCT ID: NCT03660072 Withdrawn - Multiple Myeloma Clinical Trials

Postmarketing Study of Empliciti in Korean Patients With Multiple Myeloma

Start date: January 31, 2022
Phase:
Study type: Observational

This study is a regulatory postmarketing surveillance study for Empliciti with a representative sample of the overall Korean multiple myeloma (MM) population.

NCT ID: NCT03657420 Withdrawn - Multiple Myeloma Clinical Trials

Safety and Efficacy of ABI-009 (Nab-rapamycin) in Combination With Pomalidomide and Dexamethasone for Relapsed and Refractory Multiple Myeloma

Start date: May 30, 2019
Phase: Phase 1
Study type: Interventional

This research study is studying a combination of drugs as a possible treatment for multiple myeloma. The drugs that will be administered are: - ABI-009 (nab-rapamycin) - Pomalidomide - Dexamethasone