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Multiple Myeloma clinical trials

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NCT ID: NCT06121843 Recruiting - Multiple Myeloma Clinical Trials

A Study to Evaluate the Safety, Effectiveness and Tolerable Dose of BMS-986393 in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma

Start date: February 22, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to establish a safe and tolerable dose of BMS-986393 in combinations with alnuctamab, mezigdomide, and iberdomide in participants with relapsed and/or refractory multiple myeloma (RRMM).

NCT ID: NCT06119685 Recruiting - Multiple Myeloma Clinical Trials

IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers

Start date: October 25, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open label, Phase 1/2, first-in-human, multiple ascending dose, and dose-expansion study of IDP-023 administered as a single agent and in combination with or without interleukin-2 (IL-2), and with or without daratumumab or rituximab to evaluate the safety, tolerability and preliminary antitumor activity in patients with advanced hematologic cancers.

NCT ID: NCT06107738 Recruiting - Multiple Myeloma Clinical Trials

Iberdomide and Daratumumab as Maintenance Therapy After an Autologous Stem Cell Transplant for Multiple Myeloma

IBEX
Start date: December 21, 2023
Phase: Phase 2
Study type: Interventional

The goal of this phase 2 clinical trial is to learn if patients with Multiple Myeloma who are minimal residual disease positive after initial therapy (including an autologous stem cell transplant [ASCT]) will benefit from maintenance therapy with Iberdomide and subcutaneous (SC) Daratumumab. The main questions it aims to answer are: - Assess if giving Iberdomide and the SC Daratumumab in the maintenance setting is an effective treatment and warrants further investigation in patients with residual disease - Is giving Iberdomide and SC Daratumumab maintenance post ASCT a safe option Participants will: - provide informed consent and complete screening assessments for eligibility within 28 days of starting treatment - Screening assessments include specific laboratory tests, a medical history assessment and a physical examination (including temperature, pulse, blood pressure, respirations, height and weight), an assessment of your heart function, a breathing test, cancer imaging, a bone marrow biopsy, minimal residual disease testing (MRD) and a questionnaire - If eligible, patients will start treatment with Iberdomide (1.0 mg on day 1-21 of each 28 day cycle, with an increase to 1.3 mg on Cycle 4 if the 1.0 mg dose was tolerated, to a maximum of 26 cycles or progressive disease, whichever is first) and SC Daratumumab (1800 mg SC on days 1, 8, 15 and 22 of cycle 1 and 2, then 1800 mg SC on Day 1 and 15 of cycle 3-6 and 1800 mg SC on Day 1 for cycles 7-26 to a maximum of 26 cycles or progressive disease, whichever is first) - while receiving treatment on study, physical exams (including temperature, pulse, blood pressure, respirations, height and weight), toxicity assessments, laboratory assessments and questionnaires will be done at various times over the course of the 26 cycles - an MRD assessment is required at 6, 12 and 24 months after starting treatment - End of treatment will occur once 26 cycles are completed, or cancer has progressed whichever comes first. At that time, specific laboratory tests, a physical examination (including temperature, pulse, blood pressure, respirations, height and weight), cancer imaging, a bone marrow biopsy and minimal residual disease testing (MRD) will occur.

NCT ID: NCT06106945 Recruiting - Multiple Myeloma Clinical Trials

AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory Multiple Myeloma

Start date: December 5, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase I/II, modular, open-label, multicenter, dose escalation, and dose expansion/optimization study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD0305 in participants with RRMM.

NCT ID: NCT06105554 Recruiting - Multiple Myeloma Clinical Trials

Phase I/II Open Label Study of Belumosudil Mesylate Alone, and in Combination With Dexamethasone, in Patients With Relapsed/Refractory Multiple Myeloma

Start date: January 30, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

Phase 1 is to find the recommended dose of belumosudil mesylate that can be given to patients with relapsed/refractory MM. Phase 2 is to learn if the dose of belumosudil mesylate found in Phase 1 can help to control the disease.

NCT ID: NCT06103838 Recruiting - Multiple Myeloma Clinical Trials

18F-Fluciclovine PET/CT in Multiple Myeloma

Start date: March 25, 2024
Phase: Phase 2
Study type: Interventional

Background: Multiple myeloma (MM) is an incurable cancer of certain blood cells. MM often returns after treatment, and most people survive only 5 to 8 years after diagnosis. To improve survival, researchers need to find ways to identify returning disease earlier. Objective: To find out if the radiotracer 18F-fluciclovine (a substance injected into the blood during imaging scans) is better at detecting MM than the one (18F-FDG) currently used for this purpose. Eligibility: Adults aged 18 years or older with MM. The MM may be newly diagnosed (NDMM); or it may have returned or failed to respond after at least 1 prior line of treatment (RRMM). Design: Participants will be screened. They will have blood tests. They will have a positron emission tomography (PET) or computed tomography (CT) scan using 18F-FDG. The radiotracer will be injected into a vein. Then participants will lie on a table while the PET/CT scan takes images of their body. All participants will have 3 study visits. During each visit they will have: Two PET/CT scans. One with 18F-FDG, one with 18F-fluciclovine. An optional magnetic resonance imaging scan. A bone marrow biopsy. An area on the hip will be numbed; a needle will be inserted to draw out a sample of the soft tissue from inside the bone. These tests may be spread over 30 days for each visit. NDMM participants will have their second study visit 2 to 4 weeks after they complete their usual treatment for the disease. RRMM participants will have their second visit 6 months after their first. All participants will have a third study visit after 5 years or when their disease progresses.

NCT ID: NCT06100237 Recruiting - Multiple Myeloma Clinical Trials

Teclistamab or Talquetamab in Combination With Daratumumab for High-Risk Smoldering Myeloma (REVIVE Study)

REVIVE
Start date: December 4, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to see whether combination treatment of Teclistamab and Daratumumab (Tel-Dara) or combination Talquetamab and Daratumumab (Tal-Dara) will delay the onset of multiple myeloma.

NCT ID: NCT06095752 Recruiting - Multiple Myeloma Clinical Trials

Multiple Myeloma Prognostic Indices

Start date: November 1, 2023
Phase:
Study type: Observational

The aim of this study was to evaluate the impact of albumin / fibrinogen ratio, blood viscosity and RDW on the prognosis of a newly diagnosed MM patients

NCT ID: NCT06087653 Recruiting - Multiple Myeloma Clinical Trials

Safety, Efficacy, and Pharmacokinetics of Continuous Subcutaneous Lenalidomide in Multiple Myeloma (MM)

Start date: October 2, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Primary Objective • Assess the safety and tolerability of low-dose lenalidomide administered by continuous subcutaneous (SC) infusion (STAR-LLD) in combination with dexamethasone and a proteasome inhibitor (PI). Secondary Objectives - To assess the immunologic activity of natural killer (NK) cells and T cells for innate and humoral immunity. - To establish the pharmacokinetic (PK) profile of STAR-LLD at a defined infusion rate targeting steady-state blood concentrations. - To determine pharmacodynamic (PD) changes with STAR-LLD in a panel of biomarkers associated with clinical response to lenalidomide. - Evaluate changes in efficacy indicators including objective response rate (ORR), progression-free survival (PFS), and duration of response (DOR). Exploratory Objective - To assess the impact of STAR-LLD on patient reported symptoms and outcomes. Primary Endpoints - The grade, frequency, and relationship of treatment-emergent adverse events (TEAEs) including adverse events of special interest (AESIs): (gastrointestinal [GI] toxicity, fatigue, hematologic toxicity, rash (non-infusion site). - The observation of dose-limiting toxicities (DLTs) of STAR-LLD during Cycle 1. Secondary Endpoints - Immune profiles, functional assays for NK cell activation and antigen specific T-cell activity. - Blood concentrations of lenalidomide at on Day 1 and at steady state. - Changes in biomarkers during treatment. - Rate of complete response, very good partial response (VGPR), partial response (PR), stable disease (SD), and progressive disease. - Determination of ORR, PFS, and DOR

NCT ID: NCT06084962 Recruiting - Clinical trials for Relapse/Refractory Multiple Myeloma

A Study of DeepTag-GPRC5D Targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma

Start date: October 20, 2023
Phase: Phase 1
Study type: Interventional

Clinical Trial for the safety and efficacy of DeepTag-GPRC5D targeted CAR-T cells therapy for refractory/relapsed multiple myeloma