CD38 inhibitors(Lymphocyte differentiation antigen CD38 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Antibody-dependent cellular phagocytosis (ADCP) effects

Therapeutic Areas

NeoplasmsImmune System DiseasesCardiovascular Diseases+ [6]

Active Indication

Immunoglobulin Light-Chain AmyloidosisMultiple MyelomaSmoldering Multiple Myeloma+ [21]

Inactive Indication

Adult Lymphoblastic LymphomaExtranodal NK-T-Cell LymphomaFollicular Lymphoma+ [10]

Originator Organization

Janssen Global Services LLC

Active Organization

Xian-Janssen Pharmaceutical Ltd.

Genentech, Inc.Janssen Research & Development LLC

+ [16]

Inactive Organization

Janssen-Cilag GmbH

Drug Highest PhaseApproved

First Approval Date

US (16 Nov 2015),

Multiple Myeloma

RegulationBreakthrough Therapy (US), Fast Track (US), Orphan Drug (US), Priority Review (CN), Conditional marketing approval (CN), Orphan Drug (JP), Orphan Drug (KR), Orphan Drug (GB), Priority Review (JP), Accelerated Approval (US), Orphan Drug (EU)

Structure/Sequence

Sequence Code 9075449L

Source: *****

Sequence Code 9946743H

Source: *****

309

Clinical Trials associated with Daratumumab

NCT06287944

/ RecruitingPhase 1IIT

Phase I Study of Escalating Doses of 225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody Added to the Conditioning Regimen of Fludarabine, Melphalan and Organ Sparing Total Marrow and Lymphoid Irradiation (TMLI) as Conditioning for Allogeneic Hematopoietic Cell Transplantation in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome

This phase I trial tests the safety, side effects, best dose, and effectiveness of 225Ac-DOTA-Anti-CD38 daratumumab monoclonal antibody in combination with fludarabine, melphalan and total marrow and lymphoid irradiation (TMLI) as conditioning treatment for donor stem cell transplant in patients with high-risk acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndrome (MDS). Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Radioimmunotherapy is treatment with a radioactive substance that is linked to a monoclonal antibody, such as daratumumab, that will find and attach to cancer cells. Radiation given off by the radioisotope my help kill the cancer cells. Chemotherapy drugs, such as fludarabine and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. TMLI is a targeted form of body radiation that targets marrow, lymph node chains, and the spleen. It is designed to reduce radiation-associated side effects and maximize therapy effect. Actinium Ac 225-DOTA-daratumumab combined with fludarabine, melphalan and TMLI may be safe, tolerable, and/or effective as conditioning treatment for donor stem cell transplant in patients with high-risk AML, ALL, and MDS.

Start Date18 Apr 2025

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT06622005

/ Not yet recruitingPhase 1IIT

Phase 1 Trial of SX-682, a CXCR 1/2 Inhibitor, in Combination With Standard of Care Treatment in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)

This phase I trial tests the safety and side effects of SX-682 in combination with standard of care treatment carfilzomib, daratumumab-hyaluronidase, and dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). SX-682 works by blocking certain sites on cells that suppress the ability of the immune system to destroy tumor cells. Blocking those specific sites allows other cells of the immune system to become "free" to kill tumor cells. Carfilzomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and tumor cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill tumor cells, while hyaluronidase helps to deliver daratumumab to CD38-expressing tumor cells through a subcutaneous injection. Dexamethasone is in a class of medications called corticosteroids. It is known to kill myeloma cells and is also used to reduce inflammation and lower the body's immune response to monoclonal antibodies like dratumumab and help lessen its side effects. Giving SX-682 in combination with carfilzomib, daratumumab-hyaluronidase and dexamethasone may be safe and tolerable in treating patients with relapsed or refractory multiple myeloma

Start Date01 Apr 2025

Sponsor / Collaborator

Roswell Park Comprehensive Cancer Center

NCT06785415

/ Not yet recruitingPhase 1/2IIT

Phase 1/2 Trial of Elotuzumab, Daratumumab, Iberdomide, and Dexamethasone for Relapsed Multiple Myeloma

This phase I/II trial tests the safety, side effects, and best dose of iberdomide and how well it works in combination with daratumumab, elotuzumab, and dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement (relapsed). Immunotherapy with iberdomide, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Elotuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving iberdomide in combination with daratumumab, elotuzumab, and dexamethasone may be safe, tolerable and/or effective in patients with relapsed multiple myeloma.

Start Date03 Mar 2025

Sponsor / Collaborator

Mayo Clinic

100 Clinical Results associated with Daratumumab

100 Translational Medicine associated with Daratumumab

100 Patents (Medical) associated with Daratumumab

1,916

Literatures (Medical) associated with Daratumumab

31 Dec 2025·ANNALS OF MEDICINE

Serum free light chain level-based and non-fixed cycle daratumumab treatment strategy for patients with light chain amyloidosis

Article

Author: Huang, Xianghua ; Guo, Jinzhou ; Chen, Wencui ; Li, Zhen ; Zhao, Liang ; Ren, Guisheng

BACKGROUND:

In recent years, daratumumab (DARA) has gained widespread use in the treatment of systemic light chain (AL) amyloidosis. In this study, we assessed the efficacy and safety of a DARA treatment strategy based on serum free light chain (sFLC) levels and non-fixed cycles.

METHODS:

The study included 123 patients with Al amyloidosis who received DARA at our center between July 2020 and September 2023. All patients received the standard DARA treatment (16 mg/kg weekly for four weeks) during the first course. Subsequent treatments were adjusted based on sFLC levels and the physician's judgment.

RESULTS:

The results demonstrated an impressive overall hematologic response rate (ORR) of 94.3%, with a hematologic very good partial response (VGPR) and complete response (CR) rate of 84.5%. Median time to best hematologic response was 1 months. Cardiac and renal response rates were 39.3% and 60.3%, respectively. Thirty patients experienced grade 1/2 infusion-related reactions after the first infusion. The rate of grade 3/4 adverse events was 21%. The most common adverse events of grade 3 or 4 were pulmonary infection (6.5%), neutropenia and lymphocytopenia (5.7%), elevated transaminases (1.6%), acute kidney injury (1.6%). After a median follow-up of 13 months (range 1-38), The 1-year OS and PFS estimates were 96.5% and 84.4%, respectively.

CONCLUSION:

These findings indicate that the sFLC levels based and non-fixed cycle DARA strategy is an efficacious and safe treatment strategy in both newly diagnosed and relapsed/refractory AL amyloidosis.

01 Mar 2025·PRESSE MEDICALE

Updates on mechanisms of disease progression in precursor myeloma: Monoclonal gammopathy of undermined significance and smoldering myeloma

Article

Author: Ghobrial, Irene M ; Saade, Cynthia

Monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM) are premalignant stages in the development of multiple myeloma (MM). Advances in detection, risk stratification, and therapeutic intervention have transformed our understanding of disease progression. Sensitive techniques like mass spectrometry have identified smaller monoclonal gammopathies, such as monoclonal gammopathy of indeterminate potential (MGIP), which may precede MGUS. Risk stratification models for MGUS and SMM, including the Mayo Clinic, PETHEMA, 2/20/20, IMWG, and PANGEA models, leverage tumor burden markers and cytogenetic abnormalities to predict prognosis. Genomic studies have revealed mutations, structural changes, and mutational signatures that predict progression. Immune microenvironmental alterations underscore the multifactorial nature of disease evolution, while epigenetics is emerging as a source of tumoral and microenvironmental changes. Therapies for high-risk SMM, including lenalidomide, daratumumab, and next-generation immunotherapies, demonstrate efficacy in delaying progression to MM but raise concerns regarding safety in asymptomatic patients. Future research must refine prognostic models, integrate genomic and immunophenotypic data, and establish consensus on optimal strategies for early intervention. This comprehensive review highlights the biological, clinical, and therapeutic advancements in MM and its precursors, emphasizing the importance of early risk assessment and targeted treatment to improve outcomes.

01 Mar 2025·PEDIATRIC BLOOD & CANCER

Utility of Daratumumab as Bridging Therapy in De Novo T‐Cell Acute Lymphoblastic Lymphoma

Letter

Author: Kotecha, Rishi S. ; Holzmann, Jonathan J.

504

News (Medical) associated with Daratumumab

28 Feb 2025

·synapse.patsnap.com

The Application of CAR-T in Multiple Myeloma

The conventional treatment for multiple myeloma comprises three main pillars: immunomodulatory drugs (thalidomide, lenalidomide, pomalidomide), proteasome inhibitors (bortezomib, ixazomib, carfilzomib), and monoclonal antibodies (daratumumab, isatuximab, elotuzumab, etc.). Additionally, there are several new drugs undergoing research, such as bispecific antibodies, antibody-drug conjugates (ADCs), Selective Inhibitors of Nuclear Export (XPO1), etc. Currently, CAR-T therapy has promising potential in the field of multiple myeloma treatment. CAR-T, short for Chimeric Antigen Receptor T-cell therapy, is not a drug per se, but rather an immunology-based treatment. Every person naturally possesses two immune mechanisms, or immune defenses. The first line of defense is the innate immune system, a non-antigen-specific natural defense function formed during long-term evolution and individual development. It consists of macrophages, dendritic cells, γδ T cells, NK cells, complements, cytokines, and more within the body. The second line of defense is the adaptive immune system, which includes T cells (also known as cell-mediated immunity) and B cells (also known as humoral immunity). This adaptive immune response is the whole process, during which specific T and B cells become activated, proliferate, differentiate, and induce apoptosis upon antigen stimulation, exhibiting certain biological effects. T cells and B cells can not only eliminate and clear foreign invaders and malignant lesions but also possess a memory function, which activates automatically upon recognizing previous abnormal conditions and carries out immune functions. CAR-T therapy leverages the immune function of human T cells. The T cells from the patient are collected and subjected to gene editing and amplification outside of the body, enabling the T cells to actively recognize and eliminate malignant tumor cells. Then, the modified T cells are reinfused into the patient to function effectively. Currently, CAR-T is primarily used to treat malignant hematologic diseases, including refractory multiple myeloma that have been resistant to several lines of treatment. Concurrently, many studies are also exploring its use in the treatment of solid tumors. Clinical data from various studies indicate that CAR-T has shown promising results in treating multiple myeloma, with a notable objective response rate (ORR), complete remission rate (sCR/CR), and progression-free survival (PFS). However, at present, CAR-T can only alleviate conditions and has not reached curative effects yet. CAR-T therapy also has risks. The most common complication is Cytokine Release Syndrome (CRS), it occurs due to the rapid expansion of CAR-T cells in a short period, leading to massive cytokine release causing symptoms such as fever, low blood pressure, and even organ failure. Other side effects include Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), cytopenia, hypogammaglobulinemia, and susceptibility to infections. Despite this, the aforementioned side effects are generally controllable. In terms of treating multiple myeloma, the National Medical Products Administration (NMPA) in China has approved a BCMA-targeted CAR-T product for marketing. Currently, there are over 500 CAR-T research projects worldwide, mainly covered by China and the US. Key challenges for CAR-T therapies, apart from side effects, include high costs - the high price of over 1.2 million RMB per injection deters most individuals. This high cost is due to the lengthy period of 20-30 days required to prepare "custom-made" therapy. Limitations such as CAR-T off-target effects, T cell exhaustion, and tumor cell gene mutations also lead to relapse in some patients. Additionally, the follow-up period after CAR-T treatment is not long enough, requiring further support from large sample data over a more extended period. To address these issues, researchers are developing off-the-shelf CAR-T therapies that involve the collection of T-cells from healthy individuals. This also significantly reduces the cost while continuing to explore new therapeutic targets on the basis of CD19, BCMA, and others. Apart from known CAR-T therapies, autologous hematopoietic stem cell transplantation + CAR-T, TCR-NK, TCR-T, CAR-NK, CAR-M etc., are also current hot research topics. The emergence of immunotherapy suggests a paradigm shift in cancer treatment - from pursuing more potent drug efficacy and more precise targets towards harnessing the body's own immune system to eliminate tumor cells, achieving cure or long-term progression-free survival. The level of treatment for multiple myeloma will continue to break throughUnderstanding nature is a lengthy process for humankind. Since the medical community confirmed multiple myeloma in the 1840s, the treatment primarily used cytotoxic drugs for a long time. It wasn't until the end of the last century that immunomodulatory agents such as thalidomide and proteasome inhibitors such as bortezomib came into existence, leading to an overall accelerated development period in the field of multiple myeloma treatment. The efficacy of treatments for myeloma has continuously been enhanced and patient survival has been significantly prolonged, with some scholars even proposing the concept of 'functional cure'. With the rapid advancement of generations of drugs, the addition of monoclones, double clones, antibody-conjugates, and selective nucleocytoplasmic transport inhibitors, myeloma treatment has entered an historical "gush" phase. We have reason to believe that as hematological research continues to deepen, particularly with the introduction of CAR-T therapy, there will be more and more opportunities for patients to achieve strict complete response (sCR), or MRD negativity post-treatment. Humanity will move closer and closer towards the ultimate goal of curing multiple myeloma. CAR-T Competitive Landscape As of 19 Sep 2023, there are a total of 1225 CAR-T drugs worldwide, from 553 organizations, covering 211 targets, 306 indications, and conducting 1710 clinical trials. Phase I Clinical Trial of CAR-T Medicinal: ATHENA CAR-T ATHENA CAR-T (EdiGene) is a CAR-T therapy drug that targets CD19, a protein found on the surface of certain cancer cells. It is being developed by EdiGene Inc., a pharmaceutical company specializing in gene editing technologies. The drug is currently in Phase 1 of clinical trials globally. CAR-T therapy is a type of immunotherapy that involves modifying a patient's own immune cells to recognize and attack cancer cells. CD19 is a common target for CAR-T therapies, as it is expressed on the surface of B cells, which are involved in various types of cancers, including Non-Hodgkin Lymphoma. Non-Hodgkin Lymphoma is a type of cancer that affects the lymphatic system, which is part of the immune system. It is characterized by the abnormal growth of lymphocytes, a type of white blood cell. The development of ATHENA CAR-T (EdiGene) aims to provide a potential treatment option for patients with Non-Hodgkin Lymphoma. As the drug is currently in Phase 1 of clinical trials, it is still in the early stages of development. Phase 1 trials primarily focus on evaluating the safety and dosage of the drug in a small group of patients. The results from these trials will help determine the appropriate dosage and potential side effects of ATHENA CAR-T (EdiGene). The therapeutic areas of ATHENA CAR-T (EdiGene) include neoplasms (cancer), immune system diseases, and hemic and lymphatic diseases. This suggests that the drug may have potential applications beyond Non-Hodgkin Lymphoma, although further research and clinical trials would be needed to explore these possibilities. Overall, ATHENA CAR-T (EdiGene) shows promise as a CAR-T therapy targeting CD19 for the treatment of Non-Hodgkin Lymphoma. However, as it is still in the early stages of development, more research and clinical trials are needed to determine its efficacy and safety profile. The content above comes from the network. if any infringement, please contact us to modify.

26 Feb 2025

·pipelinereview.com

Kangpu Biopharmaceuticals Received IND Approval from NMPA for KPG-818 to Treat Relapsed/Refractory Multiple Myeloma

HEFEI, China I February 25, 2025 I Kangpu Biopharmaceuticals, Ltd. (“Kangpu”) today announced that the Company has received IND approval from the CDE (Center for Drug Evaluation) of China National Medical Products Administration (NMPA) for KPG-818 for the treatment of relapsed/refractory multiple myeloma (RRMM). KPG-818 is a novel oral molecular glue modulator of the E3 ubiquitin ligase complex CRL4-CRBN. It demonstrated high cereblon (CRBN) binding affinity and potent degradation of Aiolos (IKZF3) and Ikaros (IKZF1), two members of the Ikaros family of zinc-finger transcription factors associated with B-cell development. KPG-818 possesses immunomodulatory, anti-angiogenic, and anti-tumor effects. The Phase I clinical trial of KPG-818 in the United States for the treatment of various hematological tumors has been completed. Preliminary results indicate that in RRMM patients who have previously received two immunomodulatory drugs (lenalidomide and pomalidomide), at least one proteasome inhibitor (bortezomib, ixazomib, or carfilzomib), and a CD38 monoclonal antibody (daratumumab or isatuximab), KPG-818 demonstrated good safety, tolerability, pharmacokinetic characteristics, and encouraging therapeutic effects. About Kangpu Biopharmaceuticals Kangpu Biopharmaceuticals, Ltd. is a clinical-stage company focused on the discovery and development of innovative therapeutics for the treatment of solid tumors, hematologic malignancies, autoimmune diseases, and inflammatory disorders through novel solutions, including targeted protein degradation. Kangpu has developed a robust pipeline of potential first-in-class and best-in-class drug candidates based on proprietary technology platforms, including NeoMIDES ® , gDACs ® , and X-SYNERGY ® . For more information, please visit www.KangpuGroup.com . SOURCE: Kangpu Biopharmaceuticals

Phase 1INDClinical ResultImmunotherapyPhase 2

23 Feb 2025

·synapse.patsnap.com

CD38 inhibitors——New Hope for Multiple Myeloma Patients with Medications

Multiple Myeloma (MM) is a malignant clonal plasma cell disease, accounting for about 10% of malignant tumors of the hematopoietic system. The prognosis of MM varies greatly, it is currently incurable, and most patients still face the problem of recurrence after treatment. With the emergence of new therapies such as immunomodulatory drugs (IMiDs), proteasome inhibitors (PI), and monoclonal antibodies (mAbs), the efficacy of MM has been significantly improved. CD38 is a multifunctional enzyme found on the surface of various cells in the human body, including immune cells and certain tissues. It plays a crucial role in regulating calcium signaling and cell adhesion, as well as in the metabolism of NAD+ and cADPR. CD38 is involved in immune responses, cell proliferation, and differentiation. The expression levels of CD38 molecules are relatively low in normal lymphocytes, myeloid cells, and non-hematopoietic tissue cells. However, CD38 is highly expressed in MM cells, making CD38 molecules an ideal target for MM treatment. Compared to traditional chemotherapy, anti-CD38 monoclonal antibodies have higher specificity and fewer toxic side effects. Due to their unique mechanisms of action, relatively low toxicity, and single-agent activity, anti-CD38 antibodies show great flexibility in monotherapy or combination treatment plans. CD38 Competitive LandscapeAccording to the data provided by Patsnap Synapse-Global Drug Intelligence Database: as of 10 Sep 2023, there are a total of 87 CD38 drugs worldwide, from 103 organizations, covering 56 indications, and conducting 556 clinical trials. The current competitive landscape of target CD38 is characterized by the presence of multiple companies with drugs in different phases of development. Johnson & Johnson, Sanofi, Halozyme Therapeutics, Inc., I-MAB Biopharma Co., Ltd., and Takeda Pharmaceutical Co., Ltd. are the leading companies in terms of the highest stage of development. The approved indications for drugs targeting CD38 include Multiple Myeloma, Light chain (AL) amyloidosis, and other hematologic neoplasms. Multiple Myeloma is the most common approved indication. Monoclonal antibody, CAR-T, and Bispecific antibody are the drug types progressing most rapidly under the current target CD38. These drug types indicate intense competition around the innovative drug. The United States, Japan, and China are the countries/locations with the highest development progress under the current target CD38. China, in particular, has shown significant progress with 2 drugs approved and several drugs in Preclinical phases. Overall, the target CD38 presents a competitive landscape with multiple companies and drug types vying for development and approval. The future development of target CD38 is expected to continue with advancements in research and development, particularly in the areas of monoclonal antibodies, CAR-T, and bispecific antibodies. Key Drug: Daratumumab Daratumumab is a monoclonal antibody drug that targets CD38, a protein found on the surface of certain cells. It has been approved for use in various therapeutic areas, including neoplasms, immune system diseases, endocrinology and metabolic disease, hemic and lymphatic diseases, and cardiovascular diseases. The drug has shown efficacy in treating several indications, including light chain (AL) amyloidosis, multiple myeloma, amyloidosis, hematologic neoplasms, acute lymphoblastic leukemia, extranodal NK-T-cell lymphoma, lymphoma, myelodysplastic syndromes, and immunoglobulin light-chain amyloidosis. Daratumumab was developed by Janssen Services, LLC, and it has received approval in both the global market and China. Its highest phase of development is approved, indicating that it has successfully completed clinical trials and met the necessary regulatory requirements for market authorization. The drug received its first approval in the United States in November 2015. It has undergone various regulatory processes, including priority review, pediatric investigation plan, accelerated approval, fast track designation, orphan drug status, and breakthrough therapy designation. These regulatory designations highlight the potential significance and urgency of the drug in addressing unmet medical needs. Daratumumab's approval and therapeutic areas suggest its potential in treating various diseases, particularly those related to the immune system and blood disorders. Its monoclonal antibody nature allows it to specifically target CD38, which may play a role in the pathogenesis of these diseases. Overall, Daratumumab is a promising drug in the field of biomedicine, with a wide range of potential applications in the treatment of neoplasms, immune system diseases, endocrinology and metabolic disease, hemic and lymphatic diseases, and cardiovascular diseases. Its approval in multiple indications and regulatory designations further support its potential as a valuable therapeutic option. Isatuximab-IRFC Isatuximab-IRFC is a monoclonal antibody drug that targets CD38, a protein found on the surface of certain cells. It has been developed by ImmunoGen, Inc. and has received approval for use in the treatment of multiple myeloma, a type of cancer that affects plasma cells in the bone marrow. The drug has also shown potential in the treatment of other diseases such as T-cell lymphoma, acute lymphoblastic leukemia, and colorectal cancer. Isatuximab-IRFC has been classified as an orphan drug, which means it is intended to treat rare diseases or conditions. This designation provides certain incentives to the manufacturer, such as market exclusivity and financial support for clinical trials. The drug has gone through various phases of clinical trials, with the highest phase being approved globally. It received its first approval in the United States in March 2020. In China, it is currently in phase 3 of clinical development. The therapeutic areas in which Isatuximab-IRFC is being explored include neoplasms (tumors), immune system diseases, endocrinology and metabolic diseases, hemic and lymphatic diseases, urogenital diseases, nervous system diseases, digestive system disorders, and cardiovascular diseases. This wide range of potential applications highlights the versatility of the drug and its potential to address various medical conditions. Overall, Isatuximab-IRFC represents a significant advancement in the field of biomedicine, particularly in the treatment of multiple myeloma and other related diseases. Its approval and ongoing clinical development in different countries indicate its potential to provide effective therapeutic options for patients in need. As further research and clinical trials are conducted, it is expected that the drug's applications and benefits will continue to expand, potentially benefiting a larger population of patients with different medical conditions. The content above comes from the network. if any infringement, please contact us to modify.

100 Deals associated with Daratumumab

External Link

KEGG	Wiki	ATC	Drug Bank
D10777	Daratumumab	L01XC24	DB09331

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Immunoglobulin Light-Chain Amyloidosis	EU	Janssen-Cilag International NV	20 May 2016
Immunoglobulin Light-Chain Amyloidosis	IS	Janssen-Cilag International NV	20 May 2016
Immunoglobulin Light-Chain Amyloidosis	LI	Janssen-Cilag International NV	20 May 2016
Immunoglobulin Light-Chain Amyloidosis	NO	Janssen-Cilag International NV	20 May 2016
Multiple Myeloma	US	Janssen Biotech, Inc.	16 Nov 2015

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Smoldering Multiple Myeloma	NDA/BLA	EU	Johnson & Johnson	08 Nov 2024
Residual Neoplasm	Phase 3	US	Janssen Research & Development LLC	26 Apr 2019
Residual Neoplasm	Phase 3	CA	Janssen Research & Development LLC	26 Apr 2019
Amyloidosis	Phase 3	US	Janssen Research & Development LLC	10 Oct 2017
Amyloidosis	Phase 3	US	Xian-Janssen Pharmaceutical Ltd.	10 Oct 2017
Amyloidosis	Phase 3	JP	Janssen Research & Development LLC	10 Oct 2017
Amyloidosis	Phase 3	JP	Xian-Janssen Pharmaceutical Ltd.	10 Oct 2017
Amyloidosis	Phase 3	AU	Xian-Janssen Pharmaceutical Ltd.	10 Oct 2017
Amyloidosis	Phase 3	AU	Janssen Research & Development LLC	10 Oct 2017
Amyloidosis	Phase 3	BE	Xian-Janssen Pharmaceutical Ltd.	10 Oct 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04700176 (CTgov)	Phase 2	Relapse multiple myeloma \| Multiple Myeloma \| Refractory Multiple Myeloma	1	Daratumumab+All-trans retinoic acid+pomalidomide+Dexamethasone (Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A))	isyghsutuy(osbvcixlil) = vilairimoq thcwxlwibl (ypmmtbtrvv, rtlccloqad - awhzwltein) View more	-	25 Feb 2025
				Daratumumab+All-trans retinoic acid+pomalidomide+Dexamethasone (Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B))	isyghsutuy(osbvcixlil) = qccqudodrc thcwxlwibl (ypmmtbtrvv, gbgapmzekj - fpcanilpqz) View more
NCT04151667 (CTgov)	Phase 2	Multiple Myeloma	33	Daratumumab Injection+Dexamethasone Oral (A: Daratumumab & Dexamethasone)	ikumpjbidi(vxmuxgdzlt) = jtunimjquu ukbxmnfujh (heaxvxplvs, lchwjfvbii - eshbsshztd) View more	-	30 Dec 2024
				Lenalidomide Pill+Daratumumab Injection+Dexamethasone Oral (B: Daratumumab, Dexamethasone and Lenalidomide)	ikumpjbidi(vxmuxgdzlt) = dgeitkuljp ukbxmnfujh (heaxvxplvs, asywgfohnd - uepggouvea) View more
NCT03710603 (PERSEUS, CTgov)	Phase 3	Multiple Myeloma	709	Lenalidomide+Velcade+dexamethasone (Velcade Lenalidomide Dexamethasone (VRd))	etgxmvozyh(kgyfodxpde) = sbfzorsohp vohmjmkcnj (sijdozkaky, tcliafjust - uthvwlusda) View more	-	24 Dec 2024
				Lenalidomide+Daratumumab+Velcade+dexamethasone (Daratumumab + VRd (D-VRd))	etgxmvozyh(kgyfodxpde) = oylexhjfxr vohmjmkcnj (sijdozkaky, litrespkdj - amuzaoiomi) View more
NCT03301220 (AQUILA, ASH2024) Manual	Phase 3	Smoldering Multiple Myeloma	390	Daratumumab	fcnkzvnibu(zuakpsuydr) = osictozxio bmcnpwkrul (mjrhgdlleh ) View more	Positive	09 Dec 2024
				Active Monitoring	fcnkzvnibu(zuakpsuydr) = potxborajw bmcnpwkrul (mjrhgdlleh ) View more
NCT03201965 (Andromeda, ASH2024) Manual	Phase 3	Immunoglobulin Light-Chain Amyloidosis First line	388	Daratumumab (DARA) + Bortezomib, Cyclophosphamide, and Dexamethasone (VCd)	pcwwhiosbb(ulhcvuvdka) = ausirtncah exmvujrhzm (pnwhjzapbi ) View more	Positive	09 Dec 2024
				Bortezomib, Cyclophosphamide, and Dexamethasone (VCd)	pcwwhiosbb(ulhcvuvdka) = ymtavwyxme exmvujrhzm (pnwhjzapbi ) View more
ASH2024	Not Applicable	Multiple Myeloma	-	Daratumumab (Transplant Eligible (TE) patients)	kawtfhdgfm(fekhzbtjjp) = zsftuxtkwa vijclolbwz (cdewwbcsra, -6.1 to -0.9) View more	-	09 Dec 2024
				Daratumumab (Transplant Ineligible (TIE) patients)	kawtfhdgfm(fekhzbtjjp) = msbmvxyimn vijclolbwz (cdewwbcsra, -7.6 to -2.1) View more
ASH2024	Not Applicable	Multiple Myeloma	-	Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd)	syftdbmbfo(ucdwlngvao) = nppmergsab ydfkivaaqb (kaiwljvdol ) View more	-	08 Dec 2024
				DVRd-DR	syftdbmbfo(ucdwlngvao) = fppdbjrfvj ydfkivaaqb (kaiwljvdol ) View more
ASH2024	Not Applicable	Multiple Myeloma	-	Daratumumab Plus Lenalidomide (D-R)	qrhlihgaxj(bfdcvwhujm) = vtiiokotzj hnvryfyems (ttrrwtkfct ) View more	-	08 Dec 2024
				Lenalidomide (R)	qrhlihgaxj(bfdcvwhujm) = imtajoqzgh hnvryfyems (ttrrwtkfct ) View more
NCT03652064 (CEPHEUS, ASH2024) Manual	Phase 3	Multiple Myeloma	395	Daratumumab (DARA) + Bortezomib, Lenalidomide and Dexamethasone	nowtmnscxn(hjjiqbicck) = ycxrazpghk eicysjpqrv (qijufyyujf ) View more	Positive	07 Dec 2024
				Bortezomib, Lenalidomide and Dexamethasone (VRd)	nowtmnscxn(hjjiqbicck) = wskjwxnwtn eicysjpqrv (qijufyyujf ) View more
ASH2024	Not Applicable	Multiple Myeloma	-	DARA-sensitive patients	kjtjypxikg(rfsfkiytyk) = mrkxqbjmvk xjeiqzjdyl (jdzyqwhrig, 5.5 - 9.5) View more	-	07 Dec 2024
				DARA-refractory patients	kjtjypxikg(rfsfkiytyk) = rarkwtbuww xjeiqzjdyl (jdzyqwhrig, 3.8 - 23.5) View more

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