Darzalex (daratumumab)

P2, N=103, Recruiting, Nantes University Hospital | Not yet recruiting --> Recruiting

P3, N=72, Active, not recruiting, GlaxoSmithKline

P3, N=24, Active, not recruiting, GlaxoSmithKline

P3, N=200, Active, not recruiting, The First People's Hospital of Changzhou

Based on the results of this systematic review, BCMA-directed therapies such as CAR-T cell therapy and bispecific antibodies demonstrate promising efficacy among patients with anti-CD38 refractory disease. However, additional evidence from randomized clinical trials is necessary to establish best practice guidelines.

Keywords such as "daratumumab", "carfilzomib", "diagnostic criteria" and "kidney biopsy" included recent research hotspots. Clinical physicians need to consider how to allocate medical resources reasonably, ensure that patients can receive necessary diagnosis and treatment, and explore cost-effective treatment options. The management of these patients requires interdisciplinary medical services, which should integrate basic and clinical research, especially the development of new treatment plans, to improve patients' quality of life and guide future treatment choices.

FISH demonstrated a t(11;14)(q13;q32) translocation and a gain of 1q. Despite treatments with daratumumab, bortezomib, lenalidomide, dexamethasone, and autologous stem cell transplant, the patient ultimately expired from streptococcal pneumonia with hypoxic respiratory and subsequent multiorgan failure.

P3, N=500, Recruiting, Janssen Research & Development, LLC | Trial completion date: Apr 2026 --> Jan 2029

P2, N=96, Suspended, Hackensack Meridian Health | Trial completion date: Jan 2025 --> Jan 2026 | Recruiting --> Suspended | Trial primary completion date: Jan 2025 --> Jan 2026

P2, N=13, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Apr 2025 --> Jul 2025 | Trial primary completion date: Apr 2025 --> Jul 2025

P2, N=20, Recruiting, Institute of Hematology & Blood Diseases Hospital, China | Phase classification: P1 --> P2 | Trial completion date: May 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Jan 2025 | Not yet recruiting --> Recruiting

P2, N=30, Recruiting, Institute of Hematology & Blood Diseases Hospital, China

Our results demonstrated that there were no statistically significant differences in achieving the patient-specific minimally required CD34+ cell yield after the first mobilization attempt between patients in the daratumumab-containing arm and those in the non-daratumumab-containing arm (P = 0.28).However, patients who received the quadruplet induction regimen with daratumumab experienced a statistically significant longer duration of apheresis collection (median of 2 days in the daratumumab-containing arm vs. 1 day in the non-daratumumab-containing arm, P = 0.011) than those who received traditional three-drug induction.Our findings reinforce the importance of incorporating both granulocyte-colony stimulating factors and plerixafor upfront into mobilization practices. Furthermore, the findings of this study may have implications for the judicious use of apheresis machines and further inform the optimal delivery of daratumumab-containing induction therapies for newly diagnosed multiple myeloma.

P1/2, N=103, Completed, Multiple Myeloma Research Consortium | Recruiting --> Completed | N=228 --> 103 | Trial completion date: Feb 2024 --> Dec 2024 | Trial primary completion date: Feb 2022 --> Dec 2024

In real-world, EPD is observed in more than one-fifth of patients, and it remains an unmet clinical need. Daratumumab-based therapies and ASCT significantly reduce the probability of EPD, while R2-ISS could serve as a useful prognostic tool for recognizing this population and guide therapeutic decisions.

P=N/A, N=20, Recruiting, Brigham and Women's Hospital | Not yet recruiting --> Recruiting

P1, N=7, Completed, Janssen Pharmaceutical K.K. | Phase classification: P1b --> P1

P1, N=17, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed | Trial completion date: Jun 2026 --> Jan 2025 | Trial primary completion date: Jun 2026 --> Jan 2025

P3, N=440, Recruiting, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | Not yet recruiting --> Recruiting

P2, N=30, Recruiting, Janssen Research & Development, LLC | Trial completion date: Feb 2027 --> Aug 2026

P=N/A, N=55, The First Affiliated Hospital, Zhejiang University School of Medicine; The First Affiliated Hospital, Zhejiang University School of Medicine

P=N/A, N=20, the First Affiliated Hospital of University of Science and Technology of China; the First Affiliated Hospital of University of Science and Technology

P4, N=63, Recruiting, The First Affiliated Hospital, College of Medicine, Zhejiang University; The First Affiliated Hospital, College of Medicine, Zhejiang University

The model showed strong prognostic performance in 2088 newly diagnosed MM samples and predicted response to combination therapy (daratumumab, carfilzomib, lenalidomide, and dexamethasone) in patients who failed or relapsed from bortezomib-containing regimens, with an AUC of 0.9. Integrating the m6A risk model with the International Staging System (ISS) enhanced stratification accuracy. These insights support precision treatment of MM.

P1/2, N=45, Completed, Janssen Research & Development, LLC | Active, not recruiting --> Completed

P1, N=320, Recruiting, TeneoOne Inc. | Trial completion date: Jul 2031 --> Sep 2033 | Trial primary completion date: Nov 2028 --> Sep 2033

Rituximab-based treatment is not effective, since long-lived high-affinity plasma cells do not express CD20 and do not depend on previous maturation steps to generate donor-specific antibodies. This suggests that the myeloma-like dosage used in previous reports may not be necessary for non-neoplastic diseases like antibody-mediated rejection. We propose a pragmatic approach, based on the assessment of bone marrow plasma cells after treatment, to avoid unnecessary side effects and optimize resources.

P2, N=10, Not yet recruiting, Peking University People's Hospital

P1, N=100, Recruiting, Janssen Research & Development, LLC

P3, N=520, Recruiting, GlaxoSmithKline | Not yet recruiting --> Recruiting | Trial completion date: Dec 2031 --> Apr 2032 | Trial primary completion date: Dec 2031 --> Dec 2030

P2, N=39, Not yet recruiting, UNC Lineberger Comprehensive Cancer Center | Initiation date: Dec 2024 --> Mar 2025

P1, N=10, Completed, Institute of Hematology & Blood Diseases Hospital, China | Recruiting --> Completed | Trial completion date: Dec 2026 --> Dec 2024 | Trial primary completion date: Mar 2026 --> Oct 2024

P1, N=15, Completed, Takeda | Trial primary completion date: Jan 2024 --> Jun 2024

P3, N=737, Completed, Janssen Research & Development, LLC | Active, not recruiting --> Completed

P2, N=40, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2024 --> Mar 2025 | Trial primary completion date: Dec 2024 --> Mar 2025

P1, N=126, Active, not recruiting, Genentech, Inc. | Recruiting --> Active, not recruiting | N=184 --> 126

Median number of prior lines was 4 (range 1-13), 19.4% had received CAR-T previously, and 12.9% had been previously exposed to another TCE.Twenty-three pts (74.2%) were enrolled in clinical trials (7 with teclistamab, Tec, 6 with talquetamab, Tal, and 10 with investigational agents). Twelve of these pts received TCE in combination with daratumumab and/or pomalidomide...MRD- seems to translate into long PFS, regardless of HR disease. Prospective studies on fixed duration treatment with TCE based on baseline risk and treatment response are needed.

In the current ADVANCE study (NCT04268498), patients are randomly assigned to receive 8 cycles of carfilzomib-lenalidomide-dexamethasone with or without daratumumab (i.e. Dara-KRd versus KRd). High-dose melphalan (HDM) followed by autologous stem cell transplant (ASCT) is only offered to patients who remain MRD positive after 8 cycles with all patients transitioning to maintenance lenalidomide...Using MRD testing after completed combination therapy, patients will only be offered HDM-ASCT if they remain MRD-positive after 8 cycles; otherwise, they collected stem cells will be stored (delayed transplant) and transition to maintenance therapy. The aim of this translational effort is to define the underlying biology of sustained MRD negativity in NDMM patients.

P3, N=436, Active, not recruiting, Assistance Publique - Hôpitaux de Paris | Trial primary completion date: Jul 2024 --> Jul 2026

P1/2, N=228, Active, not recruiting, Janssen Research & Development, LLC | Recruiting --> Active, not recruiting

Elotuzumab is an approved monoclonal antibody targeting SLAMF7 on plasma and NK cells that enhances the activity of lenalidomide, pomalidomide, and bortezomib in multiple myeloma (MM)...Prior therapies included: pomalidomide (33%), daratumumab (25%), and isatuximab (4%)...Common grade ≥3 adverse events were neutropenia (33%); infections, any (33%); lung infection (27%); hypophosphatemia (19%); and thrombocytopenia (15%). Elo-PVd is one of the first trials of a quadruplet regimen in relapsed/refractory MM incorporating a monoclonal antibody to show efficacy across diverse prior treatments, including triple class exposed with prior anti-CD38 monoclonal antibody.

P2/3, N=135, Recruiting, Tianjin Medical University General Hospital | N=72 --> 135 | Trial completion date: Oct 2024 --> Dec 2025 | Trial primary completion date: Aug 2024 --> Nov 2025