Darzalex Faspro (daratumumab and hyaluronidase-fihj) / J&J, Genmab, Halozyme - LARVOL DELTA

A Study of GR1803 Injection Versus Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P3 | N=358 | Recruiting | Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. (PubMed, N Engl J Med) - P3 | "The addition of subcutaneous daratumumab to VRd induction and consolidation therapy and to lenalidomide maintenance therapy conferred a significant benefit with respect to progression-free survival among transplantation-eligible patients with newly diagnosed multiple myeloma. (Funded by the European Myeloma Network in collaboration with Janssen Research and Development; PERSEUS ClinicalTrials.gov number, NCT03710603; EudraCT number, 2018-002992-16.)."

Journal • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Neutropenia • Oncology • Thrombocytopenia • Transplantation

Daratumumab or Active Monitoring for High-Risk Smoldering Multiple Myeloma. (PubMed, N Engl J Med) - P3 | "Among patients with high-risk smoldering multiple myeloma, subcutaneous daratumumab monotherapy was associated with a significantly lower risk of progression to active multiple myeloma or death and with higher overall survival than active monitoring. No unexpected safety concerns were identified. (Funded by Janssen Research and Development; AQUILA ClinicalTrials.gov number, NCT03301220.)."

Journal • Cardiovascular • Hematological Malignancies • Hypertension • Multiple Myeloma • Oncology • Smoldering Multiple Myeloma

A phase 2 Study of teclistamab in combination with daratumumab in elderly patients with newly diagnosed multiple myeloma: The IFM2021-01 teclille trial, cohort a (ASH 2025) - P2 | "The IFM2021-01 trial is a phase 2study evaluating the doublets teclistamab-daratumumab (Cohort A) and teclistamab-lenalidomide(Cohort B) in frontline transplant-ineligible patients...Daratumumab SC (1800 mg) was given weekly in Cycles 1–2, every 2 weeks inCycles 3–6, and every 4 weeks thereafter...Conclusions. IFM2021-01 Cohort A demonstrates that an "all-antibody–based" doublet regimen ofteclistamab and daratumumab is highly effective and well-tolerated in elderly patients with NDMM, withdeep responses, high MRD negativity, and a favorable safety profile."

Clinical • Combination therapy • P2 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia

Daratumumab plus bortezomib, lenalidomide, and dexamethasone (DVRd) in patients with newly diagnosed multiple myeloma (NDMM): Subgroup analysis of transplant-ineligible (TIE) patients in the phase 3 CEPHEUS study. (ASCO 2025) - P3 | "Funded by Johnson & Johnson Clinical Trial Registration Number: NCT03652064 Background: After readout of the PERSEUS and CEPHEUS trials, daratumumab-based therapy + VRd is emerging as the standard of care in NDMM treatment. In CEPHEUS TIE pts, the ≥CR rate was 80.6% and overall MRD neg rate (10−5) was 60.4%, with ~50% of pts sustaining MRD neg for ≥1 y. Nearly 70% of pts were alive and progression free at 4.5 y. These subgroup data reinforce the strong efficacy of DVRd in the TIE population."

Clinical • P3 data • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Oncology • Transplantation

Identifying Effective and Cost-Conscious Maintenance Daratumumab Dosing (clinicaltrials.gov) - P2 | N=50 | Not yet recruiting | Sponsor: Eden Biltibo

New P2 trial • Hematological Malignancies • Multiple Myeloma • Oncology

A Study to Compare the PK Characteristics, Safety, Tolerability, and Immunogenicity of HLX15-SC With DARZALEX FASPRO® in Combination With Lenalidomide and Dexamethasone (Rd) in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma (clinicaltrials.gov) - P1 | N=258 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P1 trial • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

Daratumumab plus bortezomib, lenalidomide and dexamethasone for transplant-ineligible or transplant-deferred newly diagnosed multiple myeloma: the randomized phase 3 CEPHEUS study. (PubMed, Nat Med) - P3 | "This phase 3 trial evaluated subcutaneous daratumumab plus VRd (D-VRd) in patients with transplant-ineligible NDMM or for whom transplant was not planned as the initial therapy (transplant deferred). The present study supports D-VRd quadruplet therapy as a new standard of care for transplant-ineligible or transplant-deferred NDMM. ClinicalTrials.gov registration: NCT03652064 ."

Journal • P3 data • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

A Study of Daratumumab (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Jan 2026 ➔ Jan 2029

Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Pilot Study Dara-CyBorD in Newly Diagnosed Multiple Myeloma Patients With Renal Failure (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Augusta University | Trial primary completion date: Nov 2025 ➔ Nov 2027

Trial primary completion date • Chronic Kidney Disease • Hematological Malignancies • Multiple Myeloma • Oncology • Renal Disease

Subcutaneous daratumumab plus carfilzomib and dexamethasone (D-Kd) versus carfilzomib and dexamethasone (Kd) in patients with relapsed/refractory multiple myeloma who received previous daratumumab treatment: LYNX study. (PubMed, Leuk Lymphoma) - P2 | "No new safety concerns were identified. Future studies are needed to optimize daratumumab-based regimens for patients with RRMM who have prior daratumumab exposure."

Journal • Hematological Malignancies • Multiple Myeloma • Oncology

Daratumumab in STK11 Mutated NSCLC (clinicaltrials.gov) - P2 | N=8 | Completed | Sponsor: NYU Langone Health | Recruiting ➔ Completed | N=14 ➔ 8 | Trial completion date: Dec 2026 ➔ Nov 2025 | Trial primary completion date: May 2026 ➔ Nov 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • STK11

AQUILA: A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma (clinicaltrials.gov) - P3 | N=390 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Aug 2023 ➔ Sep 2024

Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology • Smoldering Multiple Myeloma

CEPHEUS: A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy (clinicaltrials.gov) - P3 | N=395 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jan 2027 ➔ Jan 2026

Trial completion date • Bone Marrow Transplantation • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

M25-059: A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants with Multiple Myeloma Receiving Etentamig (ABBV-383) as an Intravenous (IV) Infusion Alone or in combination with Oral, IV, Subcutaneous Daratumumab; Lenalidomide; Dexamethasone; Carfilzomib (clinicaltrialsregister.eu) - P1/2 | N=10 | Not yet recruiting | Sponsor: AbbVie Deutschland GmbH & Co. KG

Adverse events • Monotherapy • New P1/2 trial • Hematological Malignancies • Multiple Myeloma • Oncology

AQUILA: A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma (clinicaltrials.gov) - P3 | N=390 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Hematological Malignancies • Multiple Myeloma • Oncology • Smoldering Multiple Myeloma

CEPHEUS: A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy (clinicaltrials.gov) - P3 | N=360 | Recruiting | Sponsor: Janssen Research & Development, LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Bone Marrow Transplantation • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

CT-P44 3.1: A study to compare Efficacy, Safety and How the Body Absorbs, Distributes, and Eliminates of Subcutaneous CT-P44 and Darzalex Faspro in Combination with Lenalidomide and Dexamethasone in Patients with Refractory or Relapsed Multiple Myeloma (clinicaltrialsregister.eu) - P2/3 | N=42 | Recruiting | Sponsor: Celltrion Inc.

New P2/3 trial • Hematological Malignancies • Multiple Myeloma • Oncology

Real MM: STUDY COMPARING TWO STANDARD TREATMENTS IN AUTOLOGOUS STEM CELL TRANSPLANTATION INELIGIBLE POPULATION AFFECTED BY MULTIPLE MYELOMA (clinicaltrials.gov) - P4 | N=350 | Recruiting | Sponsor: University of Turin, Italy | Trial completion date: Jan 2023 ➔ Jan 2025

Trial completion date • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

Daratumumab for Treatment of Refractory Podocytopathy: A Case Report. (PubMed, Kidney Med) - "But, shortly after starting the steroid tapering, the nephrotic syndrome relapsed, with a prolonged course of proteinuria that partially responded to the sequential resumption of corticosteroids, rituximab, calcineurin inhibitors, and obinutuzumab. Then, the patient was treated with weekly subcutaneous daratumumab for 8 doses, resulting in improvement of proteinuria, albuminemia, and resolution of edema that was persistent for more than 2 years. A growing body of evidence supports the rationale of an anti-CD38 strategy in the treatment of immune-mediated kidney diseases resistant to anti-CD20 agents, highlighting the role of anti-B-cell therapy in primary podocytopathy."

Journal • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Nephrology • Renal Disease

AQUILA: A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma (clinicaltrials.gov) - P3 | N=390 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jul 2025 ➔ Dec 2025

Trial completion date • Hematological Malignancies • Multiple Myeloma • Oncology • Smoldering Multiple Myeloma

AQUILA: A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma (clinicaltrials.gov) - P3 | N=390 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jan 2026 ➔ Jun 2026

Trial completion date • Hematological Malignancies • Multiple Myeloma • Oncology • Smoldering Multiple Myeloma

CEPHEUS: A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy (clinicaltrials.gov) - P3 | N=395 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Sep 2023 ➔ Aug 2025

Trial primary completion date • Bone Marrow Transplantation • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

AQUILA: A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma (clinicaltrials.gov) - P3 | N=390 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Sep 2024 ➔ May 2024

Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology • Smoldering Multiple Myeloma

CEPHEUS: A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy (clinicaltrials.gov) - P3 | N=395 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Apr 2025 ➔ Aug 2025

Trial completion date • Bone Marrow Transplantation • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation