Clinical trials: Newly Diagnosed Multiple Myeloma
Newly Diagnosed Multiple Myeloma (NDMM)
Less Doses of Daratumumab Are Adequate to Achieve Response in Newly Diagnosed Multiple Myeloma
The goal of this clinical trial is to evaluate whether a modified (less frequent) dosing schedule of daratumumab, when added to standard VRd therapy, can be an effective induction regimen for treating newly diagnosed multiple…
- Trial name
- NCT07891923
- Testing
- Daratumumab (Intravenously) with VRd (Bortezomib, Lenalidomide, and Dexamethasone)
- Where
- 2 sites in India
- Volunteers
- 52 people
- Sponsor
- Tata Memorial Centre
Newly Diagnosed Multiple Myeloma (NDMM)
REAL World IMROZ OutcomEs (REALIZE Study)
Demonstrating the real-world effectiveness of Isa-VRD in routine NHS care is the key aim for this proposal Isatuximab (Isa) is an IgG1 monoclonal antibody that binds a specific epitope on the human CD38 receptor and has…
- Trial name
- REALIZE (NCT07889323)
- Volunteers
- 150 people
- Sponsor
- The Royal Wolverhampton Hospitals NHS Trust
Newly Diagnosed Multiple Myeloma (NDMM)
A Phase III, Multicentre Study to Evaluate Consolidation Treatment With AZD0120 Compared With ASCT, in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible (DURGA-6).
The purpose of this study is to measure the efficacy of AZD0120 compared with ASCT in terms of progression-free survival (PFS) according to the International Myeloma Working Group (IMWG) criteria 2016, and MRD negative complete…
- Trial name
- DURGA-6 (NCT07735637)
- Testing
- AZD0120, Cyclophosphamide, Fludarabine
- Where
- 114 sites in United States, Australia and 16 more
- Volunteers
- 750 people
- Sponsor
- AstraZeneca
Newly Diagnosed Multiple Myeloma
A Trial to Evaluate Safety and Efficacy of Anitocabtagene Autoleucel Versus Standard of Care in Newly Diagnosed Multiple Myeloma
The goal of this clinical study iMMagine-4 is to compare and assess the safety and effectiveness of anitocabtagene autoleucel versus standard of care therapy (SOCT) in participants with newly diagnosed multiple myeloma (NDMM) who…
- Trial name
- iMMagine-4 (NCT07887672)
- Testing
- Anitocabtagene autoleucel, Daratumumab, Bortezomib
- Volunteers
- 600 people
- Sponsor
- Kite, A Gilead Company
Multiple Myeloma, Newly Diagnosed Multiple Myeloma (NDMM)
18F-Fluciclovine PET/CT in Multiple Myeloma
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.
- Conditions
- Multiple Myeloma, Newly Diagnosed Multiple Myeloma (NDMM), Relapsed and/or Refractory Multiple Myeloma (RRMM)
- Trial name
- NCT06103838
- Testing
- 18F-fluciclovine injection, 18F-FDG PET/CT
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- National Cancer Institute (NCI)
Hematological Patients, Newly Diagnosed Multiple Myeloma
Biomarkers in Multiple Myeloma
The association between multiple myeloma (MM) and venous thromboembolism (VTE) is well known. Indeed, the incidence of VTE is increased in patients with newly diagnosed MM and in patients treated by immunomodulatory drugs in…
- Conditions
- Hematological Patients, Newly Diagnosed Multiple Myeloma, Chemotherapy
- Trial name
- VESICOM (NCT05259553)
- Testing
- Blood samples
- Where
- 2 sites in France
- Volunteers
- 70 people
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
Newly Diagnosed Multiple Myeloma
Study of SubQ Dara With Dose-Attenuated Bortezomib, Lenalidomide, Dexamethasone in Elderly NDMM
This is a single center, open-label, phase 2 study in elderly (age ≥ 70) subjects with newly diagnosed multiple myeloma who are transplant ineligible.
- Trial name
- NCT04052880
- Testing
- Daratumumab, Bortezomib, Lenalidomide
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Larysa Sanchez
High Risk Newly Diagnosed Multiple Myeloma
Horizon Two: HR NDMM (MMRC-100)
The Multiple Myeloma Research Consortium (MMRC) Horizon Two trial is a master protocol, multi-center, phase II randomized adaptive platform trial designed to efficiently evaluate multiple investigational therapies in high-risk…
- Trial name
- NCT07053436
- Testing
- Bispecific Monoclonal Antibody and Triplet Therapy, Monoclonal Antibody with Stem Cell Transplant
- Where
- 12 sites in United States
- Volunteers
- 300 people
- Sponsor
- Multiple Myeloma Research Consortium
Multiple Myeloma, Newly Diagnosed
Elranatamab/Lenalidomide Consolidation and/or Elranatamab Maintenance Versus Standard of Care After D-VRd Induction in Transplant-eligible NDMM Patients
This study is designed as a multicenter, randomized, parallel groups, open-label, phase 3 study in subjects with untreated newly diagnoses Multiple Myeloma eligible for ASCT.
- Trial name
- ElLen (NCT06918002)
- Testing
- Elranatamab, Lenalidomide (Revlimid®), Daratumumab SC (Darzalex)
- Where
- 69 sites in Belgium, France
- Volunteers
- 824 people
- Sponsor
- Intergroupe Francophone du Myelome
Newly Diagnosed Multiple Myeloma
Safety and Efficacy Study of a Triplet Combination of MLN9708, Lenalidomide and Dexamethasone in the Initial Management of Multiple Myeloma (IFM2013-06)
This is a phase II, multicenter, open-label study to evaluate the safety and efficacy of MLN9708 in combination with Lenalidomide and Dexamethasone in patients with newly diagnosed multiple myeloma.
- Trial name
- IFM2013-06 (NCT01936532)
- Testing
- MLN9708, Lenalidomide, Dexamethasone
- Where
- 10 sites in France
- Volunteers
- 42 people
- Sponsor
- Nantes University Hospital
Newly Diagnosed Multiple Myeloma
Isatuximab, Iberdomide, Bortezomib, Dexamethasone in Transplant Ineligible/Deferred Newly Diagnosed Myeloma
This study is to evaluate the combination of isatuximab, iberdomide, bortezomib, and dexamethasone in newly diagnosed multiple myeloma participants who are transplant ineligible or not intended for upfront transplant.
- Trial name
- IsaIberVD (NCT07601100)
- Testing
- Isatuximab, Iberdomide, Bortezomib
- Where
- 2 sites in United States
- Volunteers
- 88 people
- Sponsor
- Dana-Farber Cancer Institute
Newly Diagnosed Multiple Myeloma
Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT
This is a randomised, multicentre, controlled, open-label, Phase III global study comparing the efficacy and safety of standard induction regimens (IsaVRd and DRd) followed by AZD0120 versus standard induction regimens followed…
- Trial name
- DURGA-5 (NCT07764978)
- Testing
- AZD0120, Daratumumab, Dexamethasone
- Where
- 124 sites in United States, Australia and 13 more
- Volunteers
- 750 people
- Sponsor
- AstraZeneca
Newly Diagnosed Multiple Myeloma, T(11;14)
A Single-center, Prospective, Single-arm Clinical Study Exploring the Treatment of Newly Diagnosed Multiple Myeloma Patients With t(11;14) Suitable for Transplantation Using the SonKRd Regimen
The goal of this study is to evaluate treatment of newly diagnosed multiple myeloma patients with t(11;14) suitable for transplantation using the SonKRd regimen, consisting of Sodium Thiotepa, Caffizotide, Lenalidomide, and…
- Conditions
- Newly Diagnosed Multiple Myeloma, T(11;14), Sotoclax, Carfilzomib
- Trial name
- NCT07709884
- Testing
- Sotoclax, Carfilzomib, Lenalidomide
- Where
- China
- Volunteers
- 20 people
- Sponsor
- The First Affiliated Hospital of Soochow University
Newly Diagnosed Multiple Myeloma
NDMM Patients Candidates for ASCT Comparing Extended VRD Plus vs. Isa-VRD vs. Isa-V-Iberdomide
This is a Phase III open-label, 3-arm, parallel, randomized, controlled trial. The allocation ratio 1:1:1 and outcome assessment are blind to group allocation. Patients will be randomized from 3 arms.
- Trial name
- GEM21menos65 (NCT05558319)
- Testing
- Bortezomib, Isatuximab, Iberdomide
- Where
- 68 sites in Spain
- Volunteers
- 480 people
- Sponsor
- PETHEMA Foundation
Multiple Myeloma, Newly Diagnosed Multiple Myeloma
ELDORADO: Elranatamab Versus Daratumumab in Combination With RVd Lite for Newly Diagnosed Transplant Ineligible/Deferred Multiple Myeloma
This research study is being done to compare the efficacy and safety of the combination of elranatamab, lenalidomide, bortezomib, dexamethasone versus the combination of daratumumab, lenalidomide, bortezomib, dexamethasone for…
- Conditions
- Multiple Myeloma, Newly Diagnosed Multiple Myeloma, Transplant Ineligible, Newly Diagnosed Multiple Myeloma (NDMM)
- Trial name
- ELDORADO (NCT07247097)
- Testing
- Elranatamab (PF-06863135), Daratumumab and Hyaluronidase-fihj, Lenalidomide
- Where
- 3 sites in United States
- Volunteers
- 160 people
- Sponsor
- Massachusetts General Hospital
Multiple Myloma, Newly Diagnosed Multiple Myeloma (NDMM)
Safety and Efficacy of RN1201 Injection as First-Line Treatment for Newly Diagnosed Multiple Myeloma
This is a single-arm, dose-escalation exploratory study evaluating the safety and efficacy of RN1201, a BCMA/CD19-targeted allogeneic CAR-T cell therapy, in patients with newly diagnosed multiple myeloma.
- Trial name
- NCT07652138
- Testing
- BCMA/CD19-targeted allogeneic CAR-T
- Where
- China
- Volunteers
- 18 people
- Sponsor
- The First Affiliated Hospital of Soochow University
Newly Diagnosed Multiple Myeloma, Multiple Myeloma
Dara-RVd Induction for Newly Diagnosed Multiple Myeloma With Autologous Stem Cell Transplantation
This Phase II hybrid decentralized trial will examine the effect of daratumumab-based quadruplet induction therapy administered at an attenuated schedule in subjects with newly diagnosed multiple myeloma (NDMM) who are eligible…
- Conditions
- Newly Diagnosed Multiple Myeloma, Multiple Myeloma, Autologous Stem Cell Transplantation
- Trial name
- NCT06348147
- Testing
- Daratumumab, Lenalidomide, Bortezomib
- Where
- United States
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Multiple Myeloma, Newly Diagnosed, Multiple Myeloma (MM)
Frontline T-cell Engager vs Autologous Stem Cell Transplant (ASCT) and Measurable Residual Disease (MRD)-Guided Sequential Intensification thERapy in Multiple Myeloma
This is an open-label, multi-site, Phase II randomized trial with response-adaptive design for newly diagnosed multiple myeloma (NDMM) participants who have had prior induction therapy.
- Trial name
- FASTER (NCT06974786)
- Testing
- Elranatamab, Daratumumab, Lenalidomide
- Where
- 11 sites in United States
- Volunteers
- 100 people
- Sponsor
- SCRI Development Innovations, LLC
Multiple Myeloma, Newly Diagnosed Multiple Myeloma (NDMM)
Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone in NDMM
This research is testing whether the investigational drug isatuximab is safe and effective when used in combination with standard agents for the treatment of newly diagnosed multiple myeloma.
- Conditions
- Multiple Myeloma, Newly Diagnosed Multiple Myeloma (NDMM), Autologous Stem Cell Transplant
- Trial name
- NCT04653246
- Testing
- Isatuximab, Lenalidomide, Bortezomib Injection
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Jacob Laubach, MD
Multiple Myeloma, Newly Diagnosed Multiple Myeloma
A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM)
The purpose of this Phase 3 study is to evaluate if BRd prolongs progression free survival (PFS) and/or improves minimal residual disease (MRD) negative status compared with DRd in participants with TI-NDMM.
- Trial name
- DREAMM-10 (NCT06679101)
- Testing
- Belantamab mafodotin, Lenalidomide, Dexamethasone
- Where
- 181 sites in United States, Argentina and 22 more
- Volunteers
- 520 people
- Sponsor
- GlaxoSmithKline