Clinical trials: Newly Diagnosed Multiple Myeloma (NDMM), open to volunteers
Multiple Myeloma
Isatuximab-VRd in Transplant-Ineligible Newly Diagnosed Multiple Myeloma Patients
Primary Objective of the trial is to evaluate the efficacy and safety of Isa-VRd-based regimen in transplant-ineligible newly diagnosed multiple myeloma (TI-NDMM) patients receiving treatment in real-world clinical practice in…
- Trial name
- CHAMPION-01 (NCT07663253)
- Testing
- Isatuximab, Bortezomib, Lenalidomide
- Where
- 13 sites in China
- Volunteers
- 333 people
- Sponsor
- Shanghai Zhongshan Hospital
Multiple Myeloma
A Study of Ramantamig Plus Daratumumab Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) or Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With NDMM For Whom Stem Cell Transplant is Not Planned
The main purpose of this study is to see how well a new treatment ramantamig-D works compared to standard treatments that is either DVRd or DRd on progression-free survival (PFS; time until a participant's disease worsens) and…
- Trial name
- TRIlogy-7 (NCT07665450)
- Testing
- Ramantamig, Daratumumab, Lenalidomide
- Where
- 103 sites in Australia, Czechia and 12 more
- Volunteers
- 1,000 people
- Sponsor
- Janssen Research & Development, LLC
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 (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
Multiple Myeloma, Newly Diagnosed
KPD Consolidation After ASCT in NDMM Patients
This study aims to evaluate the efficacy and safety of post-transplant consolidation therapy with the KPD regimen (carfilzomib, pomalidomide, and dexamethasone) versus no consolidation, followed by maintenance therapy, in…
- Trial name
- NCT06879379
- Testing
- KPD (carfilzomib, pomalidomide, and dexamethasone) consolidation
- Where
- 3 sites in China
- Volunteers
- 202 people
- Sponsor
- Peking University People's Hospital
Multiple Myeloma, Frailty
Individualized Dynamic Frailty-tailored Therapy (DynaFiT) in Elderly Patients With NDMM
Frailty is dynamic and confers poor outcomes in elderly patients with newly diagnosed multiple myeloma (NDMM), mainly because of the high prevalence of treatment discontinuation due to intolerability.
- Trial name
- DynaFiT (NCT06099912)
- Where
- China
- Volunteers
- 131 people
- Sponsor
- FengYan Jin
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
Linvoseltamab in Addition to Lenalidomide (L2) During Maintenance Therapy of NDMM to Deepen Responses or Redrive MRD Negativity After Relapse
The purpose of this study is to determine whether giving linvoseltamab with lenalidomide during maintenance treatment to participants with multiple myeloma will: 1.
- Trial name
- NCT06910124
- Testing
- Linvoseltamab, Lenalidomide
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Dickran Kazandjian, MD
Plasma Cell Myeloma
Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment
This phase III trial compares three-drug induction regimens followed by double-or single-drug maintenance therapy for the treatment of newly diagnosed multiple myeloma in patients who are not receiving a stem cell transplant and…
- Trial name
- NCT05561387
- Testing
- Bortezomib, Daratumumab and Hyaluronidase-fihj, Dexamethasone
- Where
- 397 sites in United States
- Volunteers
- 510 people
- Sponsor
- SWOG Cancer Research Network
Multiple Myeloma (MM)
Validating DW-MRI and Fat Fraction in Multiple Myeloma Post-ASCT: The RAC-FAT Study"
This is a multicenter, observational, retrospective-prospective study designed to validate the predictive role of advanced imaging in patients with newly diagnosed multiple myeloma (NDMM).
- Trial name
- NCT07746232
- Testing
- DW-MRI (MY-RADS/RAC score), Fat Fraction (rFF%), Clinical Data Collection
- Where
- 10 sites in Italy
- Volunteers
- 92 people
- Sponsor
- Fondazione EMN Italy Onlus
Multiple Myeloma, Newly Diagnosed
Comparing ASCT Followed by Anti-BCMA CAR-T vs. ASCT Alone in NDMM Patients Eligible for ASCT
This is a prospective study comparing autologous hematopoietic stem cell transplantation followed by anti-BCMA CAR-T to autologous hematopoietic stem cell transplantation alone in the treatment of newly diagnosed multiple myeloma…
- Trial name
- ASCTvsCAR-T (NCT06963866)
- Testing
- autologous stem cell transplantation, CAR-T
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Xuzhou Medical University
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), Bortezomib (BTZ), Len (lenalidomide)
- Where
- 2 sites in India
- Volunteers
- 52 people
- Sponsor
- Tata Memorial Centre
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
Newly Diagnosed Multiple Myeloma
Conversion to Carfilzomib Therapy in Bortezomib Intolerant Newly Diagnosed Multiple Myeloma(NDMM) Patients
This is an open-label, single-arm, prospective study conducted in real-world clinical practice. It aims to evaluate the efficacy and safety in Chinese patients with newly diagnosed multiple myeloma who switch to carfilzomib-based…
- Trial name
- NCT06682156
- Testing
- Carfilzomib
- Where
- China
- Volunteers
- 50 people
- Sponsor
- The First Affiliated Hospital of Soochow University
Newly Diagnosed Multiple Myeloma (NDMM)
Real-world Immuno-therapy in Chinese Newly Diagnosed Multiple Myeloma Patients
To conduct a multicenter, prospective observational cohort study to investigate first-line immunotherapy patterns and clinical outcomes in NDMM patients in China.
- Trial name
- PRIMARY (NCT07296627)
- Where
- China
- Volunteers
- 500 people
- Sponsor
- Peking University People's Hospital
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
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
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
Newly Diagnosed High-Risk Cytogenetic Multiple Myeloma Patients Ineligible or Unwilling to Undergo ASCT, Newly Diagnosed Multiple Myeloma (NDMM)
RN1201 Injection in Newly Diagnosed High-Risk Cytogenetic 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 cytogenetically high-risk multiple myeloma…
- Trial name
- NCT07114432
- Testing
- BCMA/CD19-targeted allogeneic CAR-T
- Where
- 2 sites in China
- Volunteers
- 19 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Multiple Myeloma
D2 - Isa-Iber-VD Induction, Followed by Risk & Response Adapted Consolidation & Maintenance, in Transplant-Eligible NDMM
The purpose of the study is to determine the best treatment approach based on the risk profile of the cancer cells and on how the disease responds to treatment.
- Trial name
- NCT07624513
- Testing
- Isatuximab, Iberdomide, Bortezomib (B)
- Where
- 3 sites in United States
- Volunteers
- 720 people
- Sponsor
- Dana-Farber Cancer Institute