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Neoplasms, Plasma Cell clinical trials

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NCT ID: NCT05299424 Not yet recruiting - Multiple Myeloma Clinical Trials

A Study of CM336 in Patients With Relapsed or Refractory Multiple Myeloma

Start date: April 15, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multi-center, open-label, Phase 1/2 study in China to evaluate the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics and immunogenicity of CM336 in patients with relapsed or refractory multiple myeloma. This study consists of a dose escalation part (Phase 1) and a dose extension part (Phase 2 ). The safety and tolerability of CM336 will be evaluated in Phase 1 study, as well as the maximum tolerated dose (MTD) and the recommended dose level for Phase 2 study will be determined. The efficacy of CM336 will be evaluated in Phase 2 study.

NCT ID: NCT05298683 Not yet recruiting - Multiple Myeloma Clinical Trials

A Phase 2 Study of Isatuximab in Combination With Pomalidomide and Dexamethasone in MM Patients Who Received One Prior Line of Therapy Containing Lenalidomide and a Proteasome Inhibitor

Start date: May 2022
Phase: Phase 2
Study type: Interventional

This is an investigator-initiated (IIS), phase 2, prospective, open-label, multinational study, designed to be conducted in approximately 14 sites. Eligible patients will initially receive six 28-day cycles of isatuximab, pomalidomide, and low-dose dexamethasone. Following this phase: Patients who achieve ≥VGPR will be randomized in a 1:1 ratio to receive isatuximab, given either Q2W or once monthly, plus pomalidomide and low-dose dexamethasone. Patients with <VGPR will continue treatment with isatuximab Q2W, pomalidomide, and low-dose dexamethasone. The study will last for 42 months (recruitment and follow-up period), starting from the date of the first patient in (FPI) to the date of the last patient last visit (LPLV). Core study procedures consist of baseline and post-baseline safety and disease evaluations, including physical examination, hematologic/clinical chemistry tests, radiologic assessments, bone marrow evaluations, and blood/urine M-protein assessments. Patients will be allowed to continue treatment until disease progression, death, unacceptable AEs, lost to follow-up, or consent withdrawal.

NCT ID: NCT05276141 Not yet recruiting - Multiple Myeloma Clinical Trials

A Study of Belantamab Mafodotin and Nirogacestat in People With Multiple Myeloma That Has Not Responded to Treatment or Has Come Back After Treatment

Start date: March 31, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to find out whether combination treatment with the study drugs belantamab mafodotin and nirogacestat is a safe treatment for people who have relapsed or refractory multiple myeloma. The researchers will test different doses of belantamab mafodotin to find the safest dose to give with nirogacestat. They also want to find out whether belantamab mafodotin plus nirogacestat is an effective treatment for this type of bone marrow cancer, and will do tests that show whether the study treatment slows or stops the growth of cancer.

NCT ID: NCT05272826 Not yet recruiting - Multiple Myeloma Clinical Trials

Study of Iberdomide, Bortezomib, Dexamethasone With Isatuximab Added on Demand for ND-NTE MM Patients

BOREALIS
Start date: October 2024
Phase: Phase 2
Study type: Interventional

This study will evaluate efficacy and tolerability of iberdomide, bortezomib, dexamethasone and isatuximab on demand administered in combination.

NCT ID: NCT05184595 Not yet recruiting - Multiple Myeloma Clinical Trials

Cost-Utility Analysis of Home-based Versus Hospital-based Chemotherapy in Multiple Myeloma: Case of Carfilzomib

ADHOMY2
Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Carfilzomib is administered in treatment of Multiple Myeloma intravenously on two consecutive days, each week for three weeks (days 1, 2, 8, 9, 15, and 16), followed by a 12-day rest period (days 17 to 28). With COVID pandemic, the investigators had to limit patient visits to the hospital. The treatment protocols were modified by switching to weekly injections of carfilzomib according to the PLEIADES and ARROW 2 studies. Considering the frequency of intravenous (IV) administration, home-based chemotherapy in Hospital-at-Home (HaH) setting is an attractive and suitable alternative to standard hospital-based chemotherapy in Outpatient-Hospital (OH), and is expected to provide both cost-savings for the Health Insurance (HI) and improvement in patient quality of life (QoL). The purpose of the study is to assess the cost-utility of home-based compared to hospital-based carfilzomib administration in multiple myeloma. The investigators are also planning on assessing healthcare resource utilization and related costs, adverse and intercurrent events, and patients' quality of life and satisfaction, for each strategy.

NCT ID: NCT05181501 Not yet recruiting - Multiple Myeloma Clinical Trials

A Study of Fully Human BCMA CAR-T (CT103A) in Patients With Newly Diagnosed High-risk Multiple Myeloma (FUMANBA-2)

Start date: April 2022
Phase: Phase 1
Study type: Interventional

This study is a multi-center, single-arm clinical study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamic characteristics of CT103A as the first-line treatment in newly diagnosed high-risk multiple myeloma subjects with induction chemotherapy as bridging therapy.

NCT ID: NCT05147493 Not yet recruiting - Multiple Myeloma Clinical Trials

A Phase 2 Study of Isatuximab in Combination With Bortezomib, Cyclophosphamide and Dexamethasone Followed by Isatuximab and Lenalidomide Maintenance in Newly Diagnosed Patients With Multiple Myeloma and Severe Renal Impairment

Start date: April 2022
Phase: Phase 2
Study type: Interventional

This is an Investigator-Initiated, phase 2, prospective, open-label study designed to be conducted in six hospitals in Greece. Eligible patients will initially receive an induction phase of six 28-day cycles of isatuximab in combination with bortezomib, cyclophosphamide, and dexamethasone (VCd), followed by a maintenance phase with isatuximab and lenalidomide until disease progression, death, unacceptable adverse events, lost to follow up, or consent withdrawal, whichever occurs first. The study will last for approximately 36 months (follow-up period), starting from the date of the first patient in, to the date of the last patient last visit. The primary objective is to assess the effect of induction treatment with isatuximab in combination with VCd on the renal function of newly diagnosed patients with multiple myeloma and severe renal impairment (RI). The secondary objectives are to evaluate the effect of isatuximab in combination with VCd, followed by lenalidomide maintenance on: Overall response rate, Progression-Free Survival, Time to Response, Duration of Response, Overall Survival, Minimal Residual Disease negativity rate, Safety

NCT ID: NCT05119205 Not yet recruiting - Clinical trials for Multiple Myeloma Survival Outcome

Survival Outcomes of Multiple Myeloma Patients Admitted on Assiut Clinical Hematology Unit

Start date: January 2022
Phase:
Study type: Observational

Our study will discuss survival outcomes of multiple myeloma patients admitted on Assiut clinical Hematology and role of neutrophil to lymphocyte and lymphocyte to monocyte ratios as prognostic factors in multiple myeloma.

NCT ID: NCT05088330 Not yet recruiting - Clinical trials for Newly Diagnosed Multiple Myeloma

A Study to Access of Daratumumab Combined With VRD in the Treatment of Patients With Standard-risk Newly Diagnosed MM

Start date: December 1, 2021
Phase: N/A
Study type: Interventional

This is an open-label, single arm study to access the effect of treatment with D-VRD in patients with newly diagnosed standard risk multiple myeloma.

NCT ID: NCT05050305 Not yet recruiting - Multiple Myeloma Clinical Trials

Marizomib Central Nervous System (CNS)

Start date: March 2024
Phase: Phase 2
Study type: Interventional

This research is being done to test whether the investigational drug marizomib is safe and effective when used in combination with standard of care drugs for the treatment of multiple myeloma.