A Study to Evaluate the Efficacy and Safety of Genotype-guided Targeted Agents in Combination With POLA-RCHP VERSUS POLA-RCHP in Patients With Previously Untreated Diffuse Large B-cell Lymphoma

The purpose of this study is to compare the efficacy and safety of genotype-guided targeted agents in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola RCHP-X) versus Pola RCHP in Chinese patients with previously untreated diffuse large B-cell lymphoma (DLBCL).

Start Date31 Dec 2024

Sponsor / Collaborator-

NCT06348147 / Not yet recruitingPhase 2IIT

An Attenuated Schedule Dara-RVd Induction for Patients With Newly Diagnosed Multiple Myeloma Who Are Eligible for 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 for standard-of-care autologous stem cell transplantation (ASCT). Daratumumab, lenalidomide, bortezomib, and dexamethasone (Dara-RVd) have recently become a standard induction regimen for patients with NDMM who are eligible for ASCT in the United States. As implemented in clinical trials, Dara-RVd involves twice weekly bortezomib administration, which is inconvenient for patients and may result in increased rates of limiting toxicity, such as peripheral neuropathy. Adoption of alternate schedules involving once-weekly bortezomib is common in real-world practice, however a paucity of prospective data supporting this practice exists.
This study examines the efficacy of an attenuated Dara-RVd schedule involving once-weekly bortezomib dosing.

Start Date01 Aug 2024

Sponsor / Collaborator

UNC Lineberger Comprehensive Cancer Center

NCT06207799 / Not yet recruitingPhase 2IIT

Pre-transplant Purging and Post-transplant MRD-guided Maintenance Therapy With Elranatamab in Patients With High-risk Multiple Myeloma

To learn if giving elranatamab before and after an autologous stem cell transplant (ASTC) can help to control newly diagnosed, high-risk MM. An ASTC is a type of transplant in which a person's own stem cells are collected, preserved, and returned to them.

Start Date30 Jul 2024

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+1]

100 Clinical Results associated with Lenalidomide

100 Translational Medicine associated with Lenalidomide

100 Patents (Medical) associated with Lenalidomide

5,766

Literatures (Medical) associated with Lenalidomide

31 Dec 2024·Human vaccines & immunotherapeutics

Tafasitamab for the treatment of patients with diffuse large B-cell lymphoma

Article

Author: Stathis, Anastasios ; Zucca, Emanuele ; Pirosa, Maria Cristina

Patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) require additional treatments, especially those not eligible or not responding to high dose cytotoxic chemotherapy and stem cell transplantation. Over the last few years, several new treatments have been developed and approved for these patients, among them of particular relevance are those targeting CD19. Tafasitamab is a humanized monoclonal antibody targeting CD19, composed of a modified fragment crystallizable (Fc) region engineered with higher affinity for Fc gamma receptors (FcγR) receptors, leading to increased cytotoxicity through natural killer cells and macrophages (antibody-dependent cellular cytotoxicity and antibody-dependent cell-mediated phagocytosis). In this product review, we will discuss its mechanism of action, safety profile and efficacy results from clinical trials that led to its approval in combination with lenalidomide for patients with R/R DLBCL ineligible for high-dose chemotherapy and autologous transplantation.

01 Mar 2024·Experimental hematology

Purging myeloma cell contaminants and simultaneous expansion of peripheral blood-mobilized stem cells

Article

Author: Sugiyama-Finnis, Ayano ; Ishitsuka, Kantaro ; Nishikii, Hidekazu ; Yamazaki, Satoshi ; Kimura, Takaharu

Human hematopoietic stem cells (HSCs) are widely used as a cellular source for hematopoietic stem cell transplantation (HSCT) in the clinical treatment of hematological malignancies. After transplantation therapy, delays in hematopoietic recovery due to insufficient donor-derived HSCs can lead to increased risks of life-threatening infections and bleeding. Our previous studies developed an efficient ex vivo expansion culture medium (3a medium) for umbilical cord blood-derived HSCs (CBSCs), offering a potential solution to this problem. Nevertheless, the broader applicability of our culture method to alternative cell sources and, of greater significance, its efficacy in eliminating potentially disease-associated contaminated tumor cells, especially in autologous transplantation, raise critical clinical questions. In this study, we modified the 3a medium by incorporating UM729 to replace UM171, adding FMS-like tyrosine kinase 3 (Flt3) ligand, and adjusting the concentrations of butyzamide, 740Y-P, polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (PCL-PVAc-PEG, Soluplus) to create the modified-3a medium. This sophistication allowed the efficient expansion of not only CBSCs but also peripheral blood-mobilized HSCs (PBSCs). Additionally, we successfully removed contaminated myeloma cells by adding bortezomib and tumor necrosis factor (TNF)-related apoptosis-inducing ligand (TRAIL) at appropriate concentrations, although we maintained HSCs through the addition of lenalidomide. Our research findings present the potential for widespread clinical application of the modified-3a medium and suggest a safe ex vivo culture technique for expanding human HSCs within peripheral blood-derived donor grafts used for autologous HSCT.

01 Mar 2024·Advances in therapy

Treatment Outcomes with Standard of Care in Relapsed/Refractory Diffuse Large B-Cell Lymphoma: Real-World Data Analysis

Article

Author: Wang, Anthony ; Wang, Tongsheng ; Mutebi, Alex ; Jun, Monika ; Kalsekar, Anupama ; Kamalakar, Rajesh ; Elliott, Brian ; Ip, Andrew ; Sacchi, Mariana ; Navarro, Fernando Rivas

INTRODUCTION:

Despite new therapies for relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), treatments with chemotherapy, single-agent rituximab/obinutuzumab, single-agent lenalidomide, or combinations of these agents continue to be commonly used.

METHODS:

This retrospective study utilized longitudinal data from 4226 real-world electronic health records to characterize outcomes in patients with R/R DLBCL. Eligible patients were diagnosed with DLBCL between January 2010 and March 2022 and had R/R disease treated with ≥ 1 prior systemic line of therapy (LOT), including ≥ 1 anti-CD20-containing regimen.

RESULTS:

A total of 573 patients treated with ≥ 1 prior LOT were included (31.2% and 13.4% with ≥ 2 and ≥ 3 prior LOTs, respectively). Median duration of follow-up was 7.7 months. Most patients (57.1%) were male; mean standard deviation (SD) age was 63 (14.7) years. Overall and complete response rates (95% confidence interval (CI) were 52% (48-56) and 23% (19-27). Median duration of response and duration of complete response were 3.5 and 18.4 months. Median progression-free and overall survival (95% CI) was 3.0 (2.8-3.3) and 12.9 (10.1-16.9) months, respectively. Patients with a higher number of prior LOTs, primary refractoriness, refractoriness to last LOT, refractoriness to last anti-CD20-containing regimen, and prior CAR T exposure had worse outcomes (i.e., challenging-to-treat R/R DLBCL) compared with those without these characteristics.

CONCLUSIONS:

Outcomes in patients with R/R DLBCL treated with chemotherapy, single-agent rituximab/obinutuzumab, single-agent lenalidomide, or combinations of these agents remain poor, especially for those with challenging-to-treat R/R DLBCL. These findings underscore the unmet need for new, safe, and effective therapies, especially for challenging-to-treat R/R DLBCL populations.

494

News (Medical) associated with Lenalidomide

28 Jun 2024

·www.globenewswire.com

Epcoritamab (TEPKINLY®) Receives Positive CHMP Opinion for the Treatment of Adults with Relapsed/ Refractory Follicular Lymphoma

Company Announcement Positive CHMP opinion based on results from the Phase 1/2 EPCORE® NHL-1 studyFL is the second most common type of NHL and accounts for approximately 20-30 percent of all global casesIf approved, epcoritamab (TEPKINLY®) would become the first and only bispecific antibody conditionally approved as a monotherapy in the European Union to treat both relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy COPENHAGEN, Denmark; June 28, 2024 – Genmab A/S (Nasdaq: GMAB) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of conditional marketing authorization of epcoritamab (TEPKINLY®), a T-cell engaging bispecific antibody administered subcutaneously, as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. The final European Commission decision on this indication for epcoritamab is anticipated later this year. “Many people living with follicular lymphoma that has either relapsed or is refractory to existing therapies experience significant treatment challenges with poor prognosis,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “This positive opinion recognizes the unmet need in the European Union for patients whose follicular lymphoma is considered difficult-to-treat and that epcoritamab may represent a new therapeutic option.” The CHMP opinion is supported by overall and complete response data from the Phase 1/2 EPCORE® NHL-1 clinical trial in 128 patients with R/R FL treated with epcoritamab after two or more lines of systemic therapy. The study included patients who were refractory to both anti-CD20 monoclonal antibody therapy and an alkylating agent, patients who were refractory to last prior treatment, and patients whose disease progressed within two years of first systemic therapy. In the trial, the most common (≥10%) adverse reactions were CRS, injection site reactions, pyrexia, neutropenia, anemia, thrombocytopenia, diarrhea, nausea, headache, upper respiratory tract infection, pneumonia, and rash. An additional cohort of 86 patients evaluated an optimized step-up dosing (SUD) schedule to reduce the incidence and severity of cytokine release syndrome (CRS), which is an associated side effect from immune-engaging cancer treatments. Hospitalization was not mandatory in the optimization cohort. The incidence of CRS was 49% (42 of 86 patients; 9% were grade 2) and there were no grade 3 or higher CRS events in the optimization cohort. The EPCORE NHL-1 results, including results from the optimization cohort, were recently published in the Lancet Haematology. Additionally, data from the optimization cohort were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, selected to be a part of Best of ASCO® (July 19-20, Boston, MA), and were presented at the 2024 European Hematology Association (EHA) Congress. “Each year, thousands of people in Europe are diagnosed with follicular lymphoma and it’s an upsetting reality that many of them will experience relapse and refractory disease,” said Catherine Thieblemont, M.D., Ph.D., head of the hemato-oncology department, Paris University, Hôpital Saint-Louis Assistance-Publique-Hopitaux de Paris (APHP) in Paris. “Patients deserve new treatment options, and this positive opinion is the first step to bringing epcoritamab to more patients who need it.” About the EPCORE® NHL-1 Trial EPCORE® NHL-1 is an open-label, multi-center safety and preliminary efficacy trial of epcoritamab that consists of three parts: a dose escalation part; an expansion part; and an optimization part. The trial was designed to evaluate subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma (B-NHL), including FL. In the expansion part, additional patients were enrolled to further explore the safety and efficacy of epcoritamab in three cohorts of patients with different types of relapsed/refractory B-NHLs who have limited therapeutic options. The expansion part generated pivotal data from patients with FL and DLBCL. The optimization part evaluated additional CRS mitigation strategies during cycle 1. The primary endpoint of the expansion part was overall response rate (ORR) as assessed by an Independent Review Committee (IRC). Secondary efficacy endpoints included duration of response, complete response rate, duration of complete response, progression-free survival, and time to response as determined by the Lugano criteria. Overall survival, time to next therapy, and rate of minimal residual disease negativity were also evaluated as secondary efficacy endpoints. The primary endpoint of the optimization part was the rate of ≥ Grade 2 CRS events and all grade CRS events from first dose of epcoritamab through 7 days following administration of the second full dose of epcoritamab. About Follicular Lymphoma (FL)FL is typically an indolent (or slow-growing) form of non-Hodgkin’s lymphoma (NHL) that arises from B-lymphocytes.i Although FL is an indolent lymphoma, it is considered incurable with conventional therapy and patients who achieve remission also often experience relapse.iii,iv,ii Generally, with each relapse, the remission and time to next treatment is shorter.iii,iv About EpcoritamabEpcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody® technology and administered subcutaneously. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.v Epcoritamab (approved under the brand name EPKINLY in the U.S. and Japan, and TEPKINLY in the EU) has received regulatory approval in certain lymphoma indications in several territories. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication. Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes four ongoing Phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice chemotherapy (NCT04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult participants with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with R/R FL (NCT05409066), and a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information. About Genmab Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody therapeutics. For 25 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO®) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X. Contact: Marisol Peron, Senior Vice President, Global Communications & Corporate AffairsT: +1 609 524 0065; E: mmp@genmab.com Andrew Carlsen, Vice President, Head of Investor RelationsT: +45 3377 9558; E: acn@genmab.comThis Media Release contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®, HexElect® and KYSO™. EPCORE®, EPKINLY®, TEPKINLY® and their designs are trademarks of AbbVie Biotechnology Ltd. i Lymphoma Research Foundation official website. https://lymphoma.org/aboutlymphoma/nhl/fl/. Accessed February 2024.ii Lymphoma Research Foundation official website. https://lymphoma.org/understanding-lymphoma/aboutlymphoma/nhl/follicular-lymphoma/relapsedfl/. Accessed February 2024.iii Rivas‐Delgado, A., Magnano, L., Moreno‐Velázquez, et al. Response duration and survival shorten after each relapse in patients with follicular lymphoma treated in the rituximab era. Br J Haematol. 2018;184(5):753-759. doi:10.1111/bjh.15708iv Kuruvilla J, Ewara EM, Elia-Pacitti J, et al. Estimating the Burden of Illness of Relapsed Follicular Lymphoma and Marginal Zone Lymphoma in Ontario, Canada. Curr Oncol. 2023;30(5):4663-4676. doi:10.3390/curroncol30050352v Engelberts PJ, Hiemstra IH, de Jong B, et al. DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing. EBioMedicine. 2020;52:102625. doi: 10.1016/j.ebiom.2019.102625. Company Announcement no. 49 CVR no. 2102 3884 LEI Code 529900MTJPDPE4MHJ122 Genmab A/SCarl Jacobsens Vej 302500 Valby Denmark Attachment 280624_CA49_Genmab FL CHMP Opinion

Clinical ResultPhase 3Drug ApprovalImmunotherapyASCO

27 Jun 2024

·www.fiercepharma.com

In bispecific rivalry, AbbVie's Epkinly follows Roche's Lunsumio into follicular lymphoma

AbbVie was eager to highlight that Epkinly is now the first bispecific antibody approved treat both follicular lymphoma and diffuse large B-cell lymphoma. With Regeneron’s treatment delayed, AbbVie is expanding its T-cell engager competition against Roche in blood cancer with a new FDA approval. The FDA has signed off on AbbVie and Genmab’s Epkinly to treat follicular lymphoma after at least two prior lines of therapy. Wednesday’s accelerated approval allows Epkinly to go toe to toe with Roche’s Lunsumio, which got its own third-line follicular lymphoma nod at the end of 2022. Both drugs are CD20xCD3 bispecific T-cell engagers. AbbVie was eager to highlight that Epkinly is now the first bispecific antibody approved to treat both follicular lymphoma and diffuse large B-cell lymphoma (DLBCL). The drug received its initial FDA go-ahead in May 2023 for the third-line treatment of DLBCL. In DLBCL, Roche is selling another CD20xCD3 med, Columvi, and is testing Lunsumio as part of a combination in an earlier treatment setting. Nevertheless, William Blair analyst Matt Phipps, Ph.D., sees only a limited near-term sales expansion for Epkinly. In making that projection, he cited the “limited market size for later-line lymphoma indications, as well as Lunsumio’s first-mover advantage in follicular lymphoma and similar applicability in outpatient settings,” according to a Thursday note. Epkinly’s latest nod features tumor shrinkage data from the phase 1/2 EPCORE NHL-1 trial. The trial showed an overall response rate (ORR) of 82%, including 60% complete responses, for Epkinly among 127 patients who had previously tried a median of three lines of therapy. The median duration of response was not reached after a median follow-up of 14.8 months among responders. Epkinly’s efficacy data look very similar to Lunsumio’s result from its own GO29781 trial, which recorded an 80% ORR, with 60% complete responses. After a median follow-up of 14.9 months among responders, the estimated median duration of response was 22.8 months. Compared with Lunsumio, which is administered as an intravenous infusion, Epkinly boasts the advantage of being a subcutaneous injection. Roche, for its part, is eagerly advancing subcutaneous versions of its bispecifics. Roche developed Columvi and Lunsumio in fixed durations, meaning patients stop treatment after a few cycles. Epkinly, by comparison, is given indefinitely until disease progression or unacceptable toxicity. As readily available off-the-shelf therapies, Epkinly and Lunsumio are simpler to access than CD19 CAR-T therapies. “Subcutaneous dosing offers convenience, and Epkinly can be given to patients without mandatory hospitalization using a 3-step-up dosing regimen,” AbbVie’s therapeutic area head for hematology, Mariana Cota Stirner, M.D., Ph.D., said in a statement Wednesday. The 3-step-up dosing protocol for the first cycle of treatment has shown lower incidence and severity of cytokine release syndrome and neurotoxicity but consistent efficacy compared with Epkinly’s original administration strategy used in the DLBCL indication, William Blair’s Phipps pointed out. In his note, Phipps said his team is “notably encouraged to see no requirement for hospitalization upon first cycle administration” of Epkinly in the follicular lymphoma indication, similar to the label of Roche’s Lunsumio. AbbVie and Genmab added the follicular lymphoma label three months after the FDA blocked Regeneron’s rival T-cell engager odronextamab in both follicular lymphoma and DLBCL. In its complete response letters, the FDA cited concerns around enrollment for Regeneron’s confirmatory trial programs. In explaining the decision at an American Association for Cancer Research event in April, the FDA’s oncology chief Richard Pazdur, M.D., said the move was meant to level the playing field among drug developers. “If we really believe that there are no other therapeutic alternatives, then there will be obviously some degree of flexibility,” Pazdur said. “When we do see, however, that there may be accelerated approval with the same class of drugs with the same diseases and with sponsors previously having most of the confirmatory study accrual already completed at the time of accelerated approval, we have to have a level playing field for all of the pharmaceutical companies.” With the late-line uses now endorsed by the FDA, attention around the rival bispecifics has turned to earlier treatment settings. Genmab’s phase 3 EPCORE FL-1 trial is combining Epkinly with Roche's Rituxan and Bristol Myers Squibb's Revlimid in second-line follicular lymphoma. For Roche, the phase 3 CELESTIMO trial is investigating Lunsumio and Revlimid also in the second-line setting.

Phase 3Clinical ResultDrug ApprovalAccelerated Approval

26 Jun 2024

·firstwordpharma.com

FDA tacks on third-line follicular lymphoma indication to Epkinly’s label

A year after first scoring a green light in the US for diffuse large B-cell lymphoma (DLBCL), AbbVie and Genmab’s bispecific T-cell engager Epkinly (epcoritamab-bysp) has now won accelerated approval in patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior treatments. The FDA clearance, granted following priority review, was based on data from the Phase I/II EPCORE NHL-1 study in 127 patients with relapsed or refractory FL. The CD20xCD3 bispecific led to an overall response rate (ORR) of 82%, with 60% of patients achieving a complete response. While median duration of response (DOR) was not reached after nearly 14 months, the 12-month Kaplan-Meier estimate for DOR was about 68%.Epkinly will carry a boxed warning for Immune Effector Cell-Associated Neurotoxicity (ICANS), which occurred in about 6% of patients, as well as serious or fatal cytokine release syndrome (CRS). In EPCORE NHL-1, 66.4% of patients experienced CRS, with 1.6% of cases being Grade 3 or higher. In a separate 86-patient dose optimisation cohort testing a three-step dosage regimen of Epkinly, CRS occurred in 49% of patients, with the majority being Grade 1. BMO Capital Markets analysts had previously called the high incidence of CRS "a concern." Epkinly, which was created using Genmab's DuoBody technology and administered subcutaneously, is being developed as part of a collaboration between AbbVie and Genmab that began in 2020. The partners are conducting a Phase III confirmatory study of Epkinly in combination with Rituxan (rituximab) and Revlimid (lenalidomide), compared with the two other treatments alone, in patients with relapsed or refractory FL. The trial is 95% enrolled.

Phase 3Clinical ResultPriority ReviewDrug ApprovalAccelerated Approval

100 Deals associated with Lenalidomide

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KEGG	Wiki	ATC	Drug Bank
D04687	Lenalidomide	L04AX04	DB00480

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Marginal Zone B-Cell Lymphoma	US	Bristol Myers Squibb Co.	28 May 2019
Adult T-Cell Leukemia-Lymphoma	JP	Bristol-Myers Squibb KK	02 Mar 2017
Chromosome 5q Deletion Syndrome	EU	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Chromosome 5q Deletion Syndrome	IS	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Chromosome 5q Deletion Syndrome	LI	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Chromosome 5q Deletion Syndrome	NO	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Follicular Lymphoma	EU	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Follicular Lymphoma	IS	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Follicular Lymphoma	LI	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Follicular Lymphoma	NO	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Mantle-Cell Lymphoma	EU	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Mantle-Cell Lymphoma	IS	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Mantle-Cell Lymphoma	LI	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Mantle-Cell Lymphoma	NO	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Transfusion dependent anaemia	EU	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Transfusion dependent anaemia	IS	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Transfusion dependent anaemia	LI	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Transfusion dependent anaemia	NO	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Multiple Myeloma	US	Bristol Myers Squibb Co.	29 Jun 2006
Myelodysplastic Syndromes	US	Bristol Myers Squibb Co.	27 Dec 2005

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Plasmacytoma	Phase 3	US	Millennium Pharmaceuticals, Inc.	01 Dec 2015
Plasmacytoma	Phase 3	US	Biologics, Inc.	01 Dec 2015
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 3	US	Celgene Corp.	17 Feb 2015
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 3	CN	Celgene Corp.	17 Feb 2015
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 3	JP	Celgene Corp.	17 Feb 2015
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 3	AU	Celgene Corp.	17 Feb 2015
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 3	BE	Celgene Corp.	17 Feb 2015
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 3	CA	Celgene Corp.	17 Feb 2015
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 3	CZ	Celgene Corp.	17 Feb 2015
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 3	FR	Celgene Corp.	17 Feb 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06087653 (Biospace) Manual	Phase 1	Multiple Myeloma Second line	6	STAR-LLD	qkmysgwloj(wgloyfgkjq) = lbgjkjsaoz ocrtqtsrlp (gwaujoackq )	Positive	21 Jun 2024
NCT03319667 (IMROZ, ASCO2024) Manual	Phase 3	Multiple Myeloma First line anti-CD38 monoclonal antibody	446	Isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRd)	tiwcfjnixy(jlaxnttrvy) = xpzgoobdkp oukvqyoezd (iucsppnymu, 0.406 - 0.876) View more	Positive	24 May 2024
				bortezomib, lenalidomide, and dexamethasone(VRd)	tiwcfjnixy(jlaxnttrvy) = kmwjgofdob oukvqyoezd (iucsppnymu ) View more
NCT03710603 (PERSEUS, ASCO2024)	Phase 3	Multiple Myeloma Maintenance	709	DARA SC + VRd (D-VRd)	qyipitktat(wrhrvcpadg) = mxkccqqcbs csqrqyyukc (otafwzljjc ) View more	Positive	24 May 2024
				VRd	qyipitktat(wrhrvcpadg) = kvdbdhmonj csqrqyyukc (otafwzljjc ) View more
ASCO2024	Not Applicable	Multiple Myeloma Maintenance lenalidomide	10,743	Lenalidomide-based induction followed by maintenance	reqwwkqexb(klkdjxjrot) = kisqlpqyqi bvsxgpxbhx (vpamiurwcu, 0.04 - 0.07) View more	Negative	24 May 2024
ASCO2024	Not Applicable	Maintenance	33	Proteasome inhibitor + immunomodulatory drug	avmvgtgaxn(nflhffsjqh) = bcmxdebhyh aengdtzzqu (pimfskcyho, 8.9 - NR) View more	Negative	24 May 2024
				Proteasome inhibitor + alkylator	avmvgtgaxn(nflhffsjqh) = ehubabmuwm aengdtzzqu (pimfskcyho, 8.9 - NR) View more
NCT02460276 (PHILEMON, EHA2024) Manual	Phase 2	Mantle cell lymphoma recurrent TP53 mutation	50	Ibrutinib+Lenalidomide,+Rituximab	vqczmmfvks(gsxtwcfpcc) = fmwjgwfkmy vskydjkwyr (tepizzvhox, 21.1 - NE) View more	Positive	14 May 2024
EHA2024	Not Applicable	-	360	Lenalidomide	jxjivofegr(gudmbdlrnw) = obbghtrvbz htnqwimhxb (pxetjbfbcd ) View more	-	14 May 2024
				No Lenalidomide	tmnckazuyx(jghfdcteph) = zveynuqufw asyhbmedip (lqyyexacwf, 24 - 59)
EHA2024	Not Applicable	Chromosome 5q Deletion Syndrome	-	LENALIDOMIDE	hwhadqgmcy(ehxepitngk) = revealed key regulons for proper hematopoietic differentiation, such as JARID2, IRF1 and KAT6B, with boosted aberrant activity in del(5q) cells bjxnkyasvw (mmpjclamyf ) View more	-	14 May 2024
				Patients treated with lenalidomide
NCT03308474 (MYRIAM, EHA2024)	Not Applicable	Multiple Myeloma Second line	-	DARA/LEN/Dexa	ekgwcmfarj(kfgccljokn) = xfftexkpox zzxrdjtbro (crowqwzyvm, 6.0 - 25.1)	-	14 May 2024
				BOR/DARA/Dexa	ekgwcmfarj(kfgccljokn) = gsdyfysydy zzxrdjtbro (crowqwzyvm, 4.8 - 10.4) View more
Peking Union Medical College Hospital (EHA2024)	Not Applicable	POEMS Syndrome Second line λ-restricted M protein \| IgA-type heavy chain \| VEGF	225	Lenalidomide plus dexamethasone (Rd)	yuxwyzbwku(igelsmokvx) = urfowdcrro znumegibqx (kuprmriekf ) View more	Positive	14 May 2024
				Lenalidomide maintenance treatment (R-MT)	vagcqbkvvi(sibmffmiiy) = fpybxybzvb pleqnocgxs (zbtmvmtbpx )

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