This phase II trial compares standard consolidation with daratumumab, carfilzomib, lenalidomide, and dexamethasone to consolidation with teclistamab following standard induction therapy and autologous hematopoietic stem cell transplant for improving overall survival of patients with plasma cell leukemia. Consolidation therapy is treatment given after initial therapy to kill any cancer cells that may remain in the body. 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. Carfilzomib inhibits protein complexes called proteasomes, which inhibits cancer cell growth and leads to cancer cell death. Lenalidomide may help kill cancer cells and prevents the growth of blood vessels that cancer cells need to survive. 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. Teclistamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving teclistamab as consolidation therapy after induction and autologous hematopoietic stem cell transplant may improve survival outcomes in patients with plasma cell leukemia, compared to standard consolidation with daratumumab, carfilzomib, lenalidomide, and dexamethasone.

Start Date20 Apr 2027

Sponsor / Collaborator

National Cancer Institute

NCT07029776

/ Not yet recruitingPhase 2

A Phase 2 Study Exploring the Use of Bispecific Antibodies to Improve Progression Free Survival in Patients With High-Risk Newly Diagnosed Multiple Myeloma (MMulti-Immune HR)

The purpose of this research is to learn whether using teclistamab and talquetamab at different time points will improve survival in participants with high-risk Multiple Myeloma (MM).
The treatment on this study will consist of Induction chemotherapy and stem cell collection, Immunotherapy 1 chemotherapy and Immunotherapy 2 chemotherapy. For participants whose testing show they are Minimal Residual Disease (MRD) positive (still have myeloma cells present in the bone marrow testing), a Melphalan-based stem cell transplant will be performed. For participants whose testing show they are MRD negative, the stem cell transplant will not be performed. All participants will go on to receive Immunotherapy 3 chemotherapy, Immunotherapy 4 chemotherapy, and Maintenance therapy.

Start Date01 Mar 2027

Sponsor / Collaborator

University of Arkansas Fort Smith

[+1]

NCT07903506

/ Not yet recruitingPhase 3

A Phase 3, Randomized, Open-Label, Multicenter Trial to Evaluate the Safety and Efficacy of Anitocabtagene Autoleucel Versus Autologous Stem Cell Transplant Following Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone Induction in Participants With Newly Diagnosed Multiple Myeloma

The goal of this clinical study iMMagine-6 is to compare and assess the safety and effectiveness of anitocabtagene autoleucel versus autologous stem cell transplant in participants with newly diagnosed multiple myeloma (NDMM).
The primary objective of this study is to compare the efficacy of anitocabtagene autoleucel administered after quadruplet-based induction versus standard of care therapy (SOCT; quadruplet-based induction followed by autologous stem cell transplant (auto-SCT) in participants with NDMM who are eligible for auto-SCT.

Start Date01 Feb 2027

Sponsor / Collaborator

Kite Pharma, Inc.

100 Clinical Results associated with Lenalidomide

100 Translational Medicine associated with Lenalidomide

100 Patents (Medical) associated with Lenalidomide

8,632

Literatures (Medical) associated with Lenalidomide

01 Mar 2027·Value in Health Regional Issues

Cost-Minimization Analysis of Intravenous and Subcutaneous Daratumumab in Patients With Multiple Myeloma: A Societal and Healthcare System Perspective

Article

Author: Fantelli, Valentina ; Temporin, Francesca ; Venturini, Francesca ; Riccoboni, Debora ; Zambello, Renato ; Berti, Giacomo

OBJECTIVES:

We compared costs of daratumumab (DARA) subcutaneous (SC) versus intravenous (IV) from societal and healthcare system perspectives.

METHODS:

We performed a cost-minimization analysis over 24 months using real-world weight distribution data from 304 patients treated in 2024. IV drug costs were weighted by patient distribution across 14 weight categories (6.25 kg intervals). We analyzed 4 patient scenarios (employed/unemployed, with/without caregiver) and 2 regimens (DARA-lenalidomide-dexamethasone, DARA-bortezomib-dexamethasone). Costs included drug acquisition, preparation materials, personnel time, and productivity losses. Probabilistic sensitivity analysis (10 000 Monte Carlo simulations) assessed robustness to weight distribution uncertainty. Break-even analysis identified weight thresholds at which formulations were cost equivalent.

RESULTS:

Initial IV administration required 1104 minutes versus 22 minutes for SC; subsequent IV administrations required 392 minutes. Weighted average IV drug cost was €5579 versus €5652 for SC. From a societal perspective, SC generated savings of €1125 to €11 899 across all scenarios. Probabilistic analysis showed 100% probability of SC cost saving (mean €5839; 95% CI €2204-€14 317), with weight distribution uncertainty contributing only 2% of total cost variability. Break-even analysis showed IV was marginally cheaper only in patients < 68.75 kg (42.9% of cohort). From the healthcare provider perspective, SC generated higher net revenues (€308 versus €175 per administration); payer costs remained neutral (€315 per administration regardless of route).

CONCLUSIONS:

SC DARA provides robust economic advantages across all regimens, patient scenarios, and time horizons. Despite marginal cost advantages for IV in less weight patients, the comprehensive clinical and operational benefits strongly support SC as the preferred administration route.

01 Jan 2027·CELLULAR SIGNALLING

Lenalidomide triggers ferroptosis in multiple myeloma by blocking the c-Maf/USP7 signaling pathway to induce the ubiquitination and degradation of FTH1

Article

Author: Cui, Jianan ; Zhang, Erhao ; Xu, Jintao ; Lin, Zenghua ; Jia, Hui ; Zhang, Tenglong ; Xu, Liqin ; Huang, Hongming ; Xu, Jinjin ; Zhang, Yufei ; Li, Xiaomin ; Zhang, Tingting ; Guo, Dan

Multiple myeloma (MM) is the second most common hematological malignancy. Ferroptosis, a distinct form of programmed cell death, has attracted the interest of researchers because of its unique role and biological significance across various diseases. As a first-line clinical treatment drug for MM, lenalidomide (LEN) has shown remarkable therapeutic efficacy. Accumulating evidence has highlighted the significant role of LEN in MM treatment; however, to date, no studies have investigated its potential efficacy in the ferroptosis pathway of MM and the underlying mechanisms. To investigate the therapeutic effects of LEN on MM, several in vitro and in vivo experiments were performed. Our data confirmed that LEN exerts antitumor activity in a dose-dependent manner by inducing ferroptosis, which is characterized by an abnormal increase in ROS and MDA levels, a decrease in GSH levels and mitochondrial membrane potential, and iron overload. Mechanistically, in vitro experiments have revealed that LEN directly targets the c-Maf protein and subsequently suppresses USP7 transcription, thereby inducing FTH1 degradation via the ubiquitin-proteasome pathway, triggering ferroptosis in MM cells. Finally, in vivo experiments demonstrated that LEN (10 mg/kg) significantly suppresses the c-Maf/USP7/FTH1 signaling pathway, further inhibiting MM growth by triggering ferroptosis. In conclusion, this study is the first to demonstrate that LEN suppresses MM by inducing ferroptosis via FTH1-dependent iron homeostasis, suggesting that the ferroptosis induced by the c-Maf/USP7/FTH1 signaling pathway during LEN treatment is a novel mechanism underlying its antitumor activity.

31 Dec 2026·RENAL FAILURE

Noncrystalline light-chain proximal tubulopathy: a retrospective study from a single institute of China

Article

Author: Zhao, Ming-hui ; Wang, Yu-hua ; Wang, Su-xia ; Yao, Jie-qiong ; Yu, Xiao-juan ; Yang, Li ; Zhang, Xu ; Zhou, Fu-de

Light-chain proximal tubulopathy (LCPT) is a rare disease, which is classified as crystalline or noncrystalline based on the cytoplasmic inclusions in the proximal tubules. This study aimed to investigate the clinical features of noncrystalline LCPT from a single institute of China. We retrospectively enrolled patients diagnosed with isolated noncrystalline LCPT by kidney biopsy at Peking University First Hospital between 2011 and 2024. We systematically analyzed clinical data, kidney pathological type, treatment and prognosis. Twenty patients were enrolled. The mean age at diagnosis was 58 ± 12 and the sex ratio was 4/16 (female/male). Mean proteinuria was 1.9 ± 2.3g/24 hr and the mean estimated glomerular filtration rate (eGFR) at the point of biopsy 57 ± 30 mL/min/1.73 m². κ-light chain restriction (70%) was dominant among patients with noncrystalline LCPT. An abnormal serum free light chain ratio was detected in 50% of the patients. Proximal tubulopathy without cytoplasmic inclusions/acute tubular injury (60%) was the most common type, followed by proximal tubulopathy with lysosomal indigestion/constipation (25%) and tubulopathy associated with interstitial inflammation reaction (15%). During follow-up, patients received bortezomib-based or R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisolone) or a daratumumab-lenalidomide-dexamethasone combination (DRD) chemotherapy vs. supportive treatment only. The mean follow-up time was 24 ± 22 months. All patients showed improved or stable kidney function during the observation period. This represents the first case series detailing noncrystalline LCPT with distinct pathological subtypes in northern China. Chemotherapy targeting aberrant plasma cell clones might favor kidney outcomes in patients with noncrystalline LCPT.

1,244

News (Medical) associated with Lenalidomide

29 Oct 2026

·www.fiercepharma.com

Bristol Myers' Cobenfy performance called into question amid overall Q3 revenue beat

Bristol Myers Squibb executives faced sharp questions from an analyst on Thursday regarding the slow commercial launch pace of its highly touted Cobenfy. The schizophrenia medicine’s performance was relatively underwhelming for the second quarter in a row. Despite a 30% sales bump compared to the same time last year, the $57 million in sales for the third quarter missed analyst estimates by $11 million. It doesn’t help that the drug came on the market with incredible hype. BMS acquired the therapy in 2024 for $14 billion and gained FDA approval the same year, sending expectations soaring over the first schizophrenia treatment with a novel mechanism of action in three decades. Some analysts projected $300 million in sales during its first year. In reality, the drug made a more subdued debut with $155 million in sales in 2025. Since its launch, analysts have cut the drug’s revenue predictions through 2030 by roughly 40%. On Thursday's earnings call, BMS’ chief commercialization officer, Adam Lenkowsky, noted that total prescription volume for Cobenfy increased by 3% to 4% for the quarter. But prescribing behaviors and side effects, alongside inventory issues specific to the third quarter, is weighing on the drug’s performance, he said. “We need to accelerate new patient starts. We need to improve repeat prescribing. I think one of the bigger challenges that we’ve seen is we’ve been educating physicians on the importance of rapidly titrating Cobenfy to the effective dose of 125 mg,” Lenkowsky said on the earnings call. According to Lenkowsky, far too many patients remain on the suboptimal 50 and 100-mg doses of Cobenfy due to the nausea and vomiting side effects during the initiation period. The better course of action, BMS said, is to titrate patients up to the full 125 mg and give antiemetics to manage the gastrointestinal issues. “When patients are on the effective dose and the GI toxicity is managed appropriately, we have truly seen remarkable results for this product,” Lenkowsky said. Cobenfy’s slow burn in schizophrenia has created apprehension around BMS’ closely watched phase 3 readouts in Alzheimer’s disease psychosis slated for next year. At 7 million patients in the U.S., Alzheimer’s represents a much bigger market. And about 30% to 50% of those patients experience psychosis, for which Cobenfy could be the first FDA-approved treatment if the clinical trials go as hoped. But BMS has already had to push back the readouts on two occasions: In December 2025, it delayed Adept-2 readouts because of site irregularities, and this summer, it delayed readouts of the Adept trials, citing slower-than-expected enrollment. The long-awaited results are set to come out just around the new year, and BMS needs positive results from two out of the three trials to approach the FDA. But even if the trials are a success, there’s skepticism about Cobenfy’s commercial potential and tolerability in the older Alzheimer’s population. To its advantage, Cobenfy is not associated with the boxed warnings that come with many of the existing antipsychotics, like sedation, cognitive impairment and movement disorders. “But that said, we will take the learnings from schizophrenia, and we’re going to need to set up expectations with patients and physicians, build confidence around managing the nausea and vomiting with Cobenfy,” he said. Beyond Cobenfy, BMS produced a strong quarter with a 7% increase in total revenue compared to the same time in 2025. William Blair analysts said the performance was largely driven by better-than-expected performance from the legacy portfolio, especially BMS’ blood cancer drug, Revlimid, which generated $303 million in Q3, well above analysts' estimates of $236 million. The company’s aging blood thinner, Eliquis, also saw a 25% jump in sales. BMS raised its revenue guidance for the year to $49.75 billion to $50.25 billion and assured that key readouts for milvexian—widely seen as BMS’ successor to Eliquis—and Cobenfy are still on track.

Phase 3Drug Approval

29 Oct 2026

·www.biospace.com

Starton Therapeutics Signs Clinical Trial Agreement with the Stanford School of Medicine to Evaluate STAR-LLD in Combination with Novel CAR-T Therapy for Multiple Myeloma

Investigator-initiated trial evaluating the novel combination in patients with relapsed or refractory multiple myeloma Study designed to assess safety and preliminary efficacy, while exploring the potential for STAR-LLD to enhance the performance of next-generation CAR-T therapies PARAMUS, N.J.--(BUSINESS WIRE)-- Starton Therapeutics Inc. (“Starton”), a clinical-stage biotechnology company employing standard-of-care therapies with proprietary continuous delivery technologies, announced today that it has signed a clinical trial agreement with the Stanford School of Medicine to evaluate Starton’s lead candidate STAR-LLD, in combination with a novel CAR-T cell therapy for the treatment of multiple myeloma (MM). The planned study will investigate the safety and preliminary efficacy of STAR-LLD administered in combination with the Stanford Medicine investigational CAR-T therapy in patients with relapsed or refractory multiple myeloma. The collaboration aims to explore whether STAR-LLD may enhance therapeutic responses and improve clinical outcomes when used alongside advanced cellular immunotherapies. It will also be assessing correlative biomarkers to characterize the immune effects of STAR-LLD at various doses to confirm the PK/PD relationship. “We are excited to collaborate with Stanford Medicine and advance the evaluation of STAR-LLD,” said Pedro Lichtinger, Chairman and CEO. “This agreement represents an important step in our strategy, as we believe this combination has the potential to improve CAR-T cell expansion and persistence, while minimizing the known toxicity of immunomodulatory imide drugs (IMiD).” “The use of lenalidomide in combination with CAR-T cell therapy has demonstrated an improvement in outcomes, however, is associated with significant increases in severe or life-threatening toxicities. Lenalidomide has shown potent effect on immune cell fitness, production of a favorable tumor microenvironment, and mitigation of T cell exhaustion all of which may have a positive effect on CAR-T’s long-term persistence,” said Jamie Oliver, Starton’s Chief Medical Officer. “By providing low-dose continuous delivery of lenalidomide we may decrease the concomitant toxicity observed with current lenalidomide oral formulations while maintaining the immunologic activity observed with the IMiD class of drugs.” “We look forward to exploring how the combination of STAR-LLD with our novel BCMA directed CAR-T therapy might impact outcomes,” added Lekha Mikkilineni, MD, MA, Assistant Professor of medicine at Stanford Medicine. “We intend to present the data from this study for publication in scientific forums.” While Stanford Medicine is solely responsible for the protocol and conduct of the study, Starton anticipates using the data to support a Phase 2 IND in combination with BCMA CAR-T’s in MM. About STAR-LLD STAR-LLD is a continuous delivery lenalidomide (LLD) in development seeking to expand and replace the standard-of-care for the most common blood cancers, multiple myeloma (MM), and chronic lymphocytic leukemia (CLL). A preclinical proof-of-concept study for subcutaneous STAR-LLD demonstrated that MM tumors caused by human myeloma cells grew 25-fold if untreated, five-fold when treated with daily lenalidomide, and shrank by 80% with STAR-LLD over a single 28-day cycle. The study also showed a 100% overall response rate (ORR) using continuous delivery LLD with 20% of animals in this cohort tumor-free after 100 days; by contrast, there was a 0% ORR in animals treated with a 70% higher dose of lenalidomide given in single daily doses. In addition, a Phase 1b clinical study of six relapsed/refractory MM patients resulted in all patients that received STAR-LLD achieving an objective response (1 CR and 5 PRs); no patients experienced drug-related anemia, neutropenia, leukopenia, or thrombocytopenia greater than grade 2 in up to 12 cycles of therapy. The Phase 1b clinical study concluded that continuous delivery of low dose lenalidomide (STAR-LLD) provides meaningful efficacy and improved tolerability with no grade > 2 drug-related hematologic toxicity. About Starton Therapeutics Starton Therapeutics is a clinical-stage biotechnology platform company focused on transforming standard-of-care therapies with proprietary continuous delivery technology, so people with cancer live better, for longer. Starton’s proprietary technology is intended to increase the efficacy of approved drugs, make them more tolerable, and expand their potential use. To learn more, visit . Forward Looking Statements All statements other than statements of historical facts included in this press release, including, without limitation, statements regarding our plans and objectives for future operations and expectations about current and future clinical trials, constitute “forward-looking statements.” Forward-looking statements are subject to numerous conditions and known and unknown risks and uncertainties that could cause our actual results or events to differ materially from those included within the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, and, except as required by law, Starton undertakes no obligation to disclose any revision to these forward-looking statements whether as a result of new information, future events, or otherwise. Contacts Investor Relations Contact Lee Roth Burns McClellan lroth@burnsmc.com Media Relations Contact Greg Salsburg STiR-communications Greg@STiR-communications.com

ImmunotherapyPhase 1Cell TherapyClinical Result

29 Oct 2026

·www.biospace.com

BMS drops Prothena-partnered neuro drug, sales outlook improves on a Q3 beat

iStock, masterSergeant In addition to canning an Orum-acquired blood cancer candidate last month, Bristol Myers Squibb cut a Prothena-partnered neuro asset in the third quarter. But with sales climbing 7%, the Big Pharma raised its full-year revenue forecast. Bristol Myers Squibb has shelved two biotech-partnered pipeline candidates after reviewing early data, while also disclosing third quarter results that prompted the pharma to raise its full-year revenue outlook. The first axed asset, known as BMS-986495 or PRX019, is an investigational monoclonal antibody that BMS licensed from Prothena in May 2024 for $80 million upfront and up to $617 million in biobucks, plus potential royalties. The asset is designed to treat neurodegeneration, though publicly shared details are sparse, with the completed Phase 1 trial conducted among healthy adults. “Following review of Phase 1 data, we have decided not to advance this program,” a BMS spokesperson told BioSpace in an email. BioSpace has reached out to Prothena about its plans for PRX019 and how the decision will impact its organization. Other aspects of BMS’ Prothena partnership will continue. The biotech initially teamed up with Celgene in 2018 to develop new neuroscience therapies. After BMS acquired Celgene for $74 billion in 2019, the pharma began working with Prothena on the monoclonal antibody known as moponetug, or PRX005, for Alzheimer’s disease. The tau-targeting candidate has secured fast track designation from the FDA and is currently being evaluated in a Phase 2 trial set to read out in the first half of next year. “Our neuroscience collaboration with Prothena continues,” the BMS spokesperson said, confirming moponetug’s ongoing development in Alzheimer’s. Cancer BMS scraps Orum’s targeted degrader after reviewing Phase 1 data Bristol Myers Squibb acquired the degrader-antibody conjugate from Orum Therapeutics in 2023 for $100 million upfront and the possibility of up to $80 million more in milestones. September 18, 2026 · 1 min read · Tristan Manalac Read more In the third quarter, BMS also discontinued an early-stage degrader-antibody conjugate (DAC) picked up from Korean biotech Orum Therapeutics. The pharma ended development of the blood cancer asset, which it acquired in 2023 for $100 million upfront and up to $80 million in milestones, “after reviewing the clinical data for the program,” according to a September regulatory filing from Orum. The decision was made after determining that the overall risk-benefit pro ORM-6151 doesn’t support further development, the BMS spokesperson said on Thursday. Stronger sales and high-stakes pipeline readouts The pipeline cuts come as BMS works to build a new generation of revenue drivers ahead of looming exclusivity losses for PD-1 blockbuster Opdivo and Pfizer-partnered blood thinner Eliquis. Last year, Eliquis brought in $14.4 billion in global sales, while Opdivo secured $10 billion—together accounting for roughly half of BMS’ $48.2 billion total revenue . Analysts have scrutinized BMS’ pipeline plans, with BMO’s senior biopharma analyst Evan Seigerman citing the risky nature of several of the assets BMS has teed up as potential revenue replacements. But today, the pharma delivered top- and bottom-line beats—3% and 23%, respectively—that “continue to support a better commercial story for Bristol,” Seigerman and colleagues wrote in a Thursday investor note. BMS’ growth and legacy portfolios both delivered revenue slightly above consensus expectations, with the subcutaneous Opdivo Qvantig beating consensus by 5% on improved convenience, and the legacy products driven by stronger-than-expected revenues from Eliquis at $4.62 billion and Revlimid at $303 million revenue. For the third quarter, the company’s revenue increased 7% to $13.1 billion, beating a $12.75 billion consensus. BMS has now raised topline guidance for the full year by 1%, from a range of $49–$50 billion to $49.75–$50.25 billion. However, due to a $1.65 billion acquisition-related hit for the first nine months of the year, expectations for earnings per share dropped from $6.75–$7 to $6.35–$6.55. Business BMO most bullish on Merck’s, bearish on BMS’ plans to contend with patent cliffs BMO Capital Markets is more impressed by Merck’s plans to replace lost Keytruda revenue than on Bristol Myers Squibb’s efforts to fill the expected void that will come from loss of exclusivity for both Opdivo and Eliquis. October 2, 2026 · 4 min read · Gabrielle Masson Read more Notably, data for milvexian—a Johnson & Johnson–partnered oral Factor XIa inhibitor—in secondary stroke prevention remains on track for this year, BMO wrote. This summer, BMS delayed a Phase 3 readout for the candidate in atrial fibrillation into 2027. The asset is one of three key pipeline programs BMS is pinning its hopes on, alongside schizophrenia medicine Cobenfy and late-stage pulmonary fibrosis candidate admilparant. Elsewhere in the pipeline, BMS is working to address safety concerns in its autoimmune CAR T program, including a death that was disclosed late last week. The patient had multiple sclerosis and died from septic pneumonia after receiving BMS’ zolacabtagene autoleucel (zola-cel). The pharma had voluntarily paused some autoimmune trials of zola-cel in August but appears to still be bullish on the CAR T’s potential. “We truly remain excited about [the] zola-cel program because when we look at the totality of our data, we had 190 patients treated in Phase 1,” BMS Chief Medical Officer Cristian Massacesi said on the investor call. “The overall safety and efficacy pro this product is truly compelling. “After an extensive analysis of all our data, we identified that the root cause was a change that we made in the selection and activation of the reagent,” he explained. “We [have] now made the proper adjustment of it, and we are working with authority to restart the clinical program as soon as possible.” Autoimmune diseases BMS reveals death from septic pneumonia of multiple sclerosis patient in CAR T trial The disclosure—which came ahead of a presentation of data from the Phase 1 Breakfree-2 study at the ACTRIMS-ECTRIMS meeting—follows Bristol Myers Squibb’s late summer revelation that it had paused certain trials of zolacabtagene autoleucel. October 23, 2026 · 3 min read · Heather McKenzie Read more Despite the setbacks, execs pointed to late-stage progress—like the recent radiopharmaceutical win in a late-stage Phase 3 tumor trial—while emphasizing the need to strengthen earlier efforts, too. “We’ve got some wind at our back with respect to late-stage development,” BMS CEO Chris Boerner said on a Thursday investor call. “But clearly there’s a lot of focus we have as a company on strengthening R&D and continuing to deliver not just on that late-stage pipeline but also progress the earlier pipeline, so that we drive sustained growth over time.” The Big Pharma remains open to striking deals for external innovation that align with BMS’ priorities, Boerner said. Earnings BMS’ ‘big beat’ clouded by Cobenfy, heart disease data delays Strong quarterly results are prompting Bristol Myers Squibb to lift its 2026 outlook, though the company is facing another delay for key Cobenfy Alzheimer’s data and a pushed-back readout for milvexian. July 30, 2026 · 4 min read · Gabrielle Masson Read more

Phase 1Phase 3AcquisitionPhase 2Fast Track

100 Deals associated with Lenalidomide

External Link

KEGG	Wiki	ATC	Drug Bank
D04687	Lenalidomide	L04AX04	DB00480

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Large B-cell lymphoma	United States	Seagen, Inc.	11 Feb 2025
Marginal Zone B-Cell Lymphoma	United States	Bristol Myers Squibb Co.	28 May 2019
Adult T-Cell Leukemia-Lymphoma	Japan	Bristol-Myers Squibb KK	02 Mar 2017
Chromosome 5q Deletion Syndrome	European Union	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Chromosome 5q Deletion Syndrome	Iceland	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Chromosome 5q Deletion Syndrome	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Chromosome 5q Deletion Syndrome	Norway	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Follicular Lymphoma	European Union	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Follicular Lymphoma	Iceland	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Follicular Lymphoma	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Follicular Lymphoma	Norway	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Mantle-Cell Lymphoma	European Union	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Mantle-Cell Lymphoma	Iceland	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Mantle-Cell Lymphoma	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Mantle-Cell Lymphoma	Norway	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Transfusion dependent anaemia	European Union	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Transfusion dependent anaemia	Iceland	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Transfusion dependent anaemia	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Transfusion dependent anaemia	Norway	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Multiple Myeloma	United States	Bristol Myers Squibb Co.	29 Jun 2006

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Crouzon Syndrome With Acanthosis Nigricans	Phase 3	Japan	Chugai Pharmaceutical Co., Ltd.	07 Mar 2024
Cytopenia	Phase 3	Japan	Chugai Pharmaceutical Co., Ltd.	07 Mar 2024
Hyperhidrosis	Phase 3	Japan	Chugai Pharmaceutical Co., Ltd.	07 Mar 2024
Pain	Phase 3	Japan	Chugai Pharmaceutical Co., Ltd.	07 Mar 2024
Thromboembolism	Phase 3	Japan	Chugai Pharmaceutical Co., Ltd.	07 Mar 2024
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	United States	Incyte Corp.	11 May 2021
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	Japan	Incyte Corp.	11 May 2021
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	Argentina	Incyte Corp.	11 May 2021
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	Australia	Incyte Corp.	11 May 2021
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	Austria	Incyte Corp.	11 May 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04808037 (BelaRd, ESMO2026)	Phase 1/2	First line	42	Belantamab mafodotin+lenalidomide+dexamethasone (Group A)	sxxmsubpgq(msdoxrkmqn) = bntgplewuf gqsbspyqje (irqyednfjc ) View more	Positive	23 Oct 2026
				Belantamab mafodotin+lenalidomide+dexamethasone (Group B)	dzpgbdfcaq(bskkvcotqg) = juesipdcot tlvhmjdfpr (iqcrdsgfpm ) View more
NCT04661007 (J-MIND, CTgov)	Phase 1/2	Diffuse large B-cell lymphoma refractory \| Diffuse Large B-Cell Lymphoma \| Diffuse large B-cell lymphoma recurrent	72	Tafasitamab (Phase 1, Part 1, Group 1: Tafasitamab Monotherapy)	ppxujdfzgt = jsfkgdsugm rwpqcfiwnl (miapdnekkx, wtihmfczws - guaffkrcgd) View more	-	21 Oct 2026
				Lenalidomide (LEN)+Tafasitamab (Phase 1, Part 2, Group 2: Tafasitamab Plus Lenalidomide (LEN))	ppxujdfzgt = rffkkscbje rwpqcfiwnl (miapdnekkx, glkrgarhlo - mwuvxqcecb) View more
IMS2026	Not Applicable	Multiple Myeloma	5	iMiD (Outpatient desensitisation pathway)	ukqocswktp(fgcsvmsutp) = Reactions ranged from grade 1 rash to extensive eruptions involving >80% body surface area, including one case of DRESS syndrome attributed to co-trimoxazole in the setting of concurrent lenalidomide therapy. Breakthrough cutaneous reactions occurred in three patients during dose escalation which did not preclude rechallenge. Two patients discontinued desensitisation due to intercurrent clinical factors, including infection and disease progression, rather than refractory hypersensitivity. ziqiibwaoy (rcrdxiwzlf )	Positive	23 Sep 2026
IMS2026	Not Applicable	Multiple Myeloma	2,420	Lenalidomide maintenance	hyscgejdmg(vbvbncerkt) = SPM occurrence was independently associated with inferior OS (HR 2.58, 95% CI 2.06-3.24; p< 0.0001). rvuiqarpmc (dasimnfsml ) View more	Negative	23 Sep 2026
DETERMINATION (IMS2026)	Phase 3	Multiple Myeloma Duffy null status	493	Lenalidomide+Bortezomib+Dexamethasone	hmwncnmnjw(slkwfpdeui) = duhbejwcqw vzpgfppmol (axsfomvpaf )	Positive	23 Sep 2026
				Lenalidomide+Bortezomib+Dexamethasone (ASCT)	hmwncnmnjw(slkwfpdeui) = yakrfedkdz vzpgfppmol (axsfomvpaf )
IMS2026	Not Applicable	Multiple Myeloma First line	2,493	Daratumumab, bortezomib, lenalidomide, and dexamethasone (DVRd)	xrtxkixekv(aiwunjljds) = lmddljxkts fmjzuptbef (phrjezhydp ) View more	Positive	23 Sep 2026
				Bortezomib, lenalidomide, and dexamethasone (VRd)	xrtxkixekv(aiwunjljds) = pslgsxzukh fmjzuptbef (phrjezhydp ) View more
IMS2026	Not Applicable	Multiple Myeloma	14	Isatuximab+Bortezomib+Lenalidomide+Dexamethasone	tfqipcaymz(ifwdfvjbkp) = 40% (4/10) aakoqyskzf (ixmymwvvsv ) View more	Positive	23 Sep 2026
NCT03829371 (REAL MM, IMS2026)	Phase 4	Multiple Myeloma	401	Bortezomib-melphalan-prednisone (VMP)	uugjyeofmy(vpvtdxnypo) = jstuijomzq nnzgvwygtz (smnvepltkv )	Positive	23 Sep 2026
				Bortezomib+melphalan+prednisone+daratumumab (DVMP)	-
IMS2026	Not Applicable	Multiple Myeloma First line	62	D-BTd	srgdnesbak(tcahbdgfib) = irpvfgxwqu watibimfaq (whdurmhdpt ) View more	Positive	23 Sep 2026
				D-VRd	srgdnesbak(tcahbdgfib) = kvwjutgccd watibimfaq (whdurmhdpt ) View more
IMS2026	Phase 2	Multiple Myeloma First line	120	Ixazomib + Lenalidomide	ironrqgeyl(kpetdxvgsn) = 95% of the patients with sustained (two negative samples every 12 months) NGF-MRD negativity were progression-free at 2 years on maintenance. nampaanxeb (wfrmfxnhey ) View more	Positive	23 Sep 2026
				Lenalidomide

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