Elotuzumab plus lenalidomide and dexamethasone for newly diagnosed multiple myeloma: a randomized, open-label, phase 2 study in Japan

Kubo, Kohmei; Hori, Mitsuo; Ohta, Kensuke; Handa, Hiroshi; Hatake, Kiyohiko; Matsumoto, Morio; Hagiwara, Shotaro; Ohashi, Kazuteru; Nakaseko, Chiaki; Suzuki, Kenshi; Ito, Shigeki; Kinoshita, Gen; Shelat, Suresh G.; Miyoshi, Masafumi; Takezako, Naoki

doi:10.1007/s12185-019-02757-0

Cited by 13 publications

(5 citation statements)

References 32 publications

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“…A phase II clinical trial (NCT01478048) showed that, compared with bortezomib and DEX (BD), BD plus elotuzumab significantly increased the median PFS (9.7 vs. 6.9 months) in patients with RRMM [ 53 ]. Another phase II study (NCT 02,272,803) [ 54 ] evaluated the efficacy and safety of elotuzumab plus RD (ERD) versus RD in newly diagnosed, transplant-ineligible patients in Japan. Latest results showed that ORR was 88% [70% (CI) 80–93] in the ERD arm (the PFS data was not reached).…”

Section: Monoclonal Antibodiesmentioning

confidence: 99%

Emerging agents and regimens for multiple myeloma

Yang

et al. 2020

J Hematol Oncol

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The outcomes of multiple myeloma (MM) have been improved significantly with the therapies incorporating proteasome inhibitors (PI), immunomodulatory drugs, monoclonal antibodies (MoAb) and stem cell transplantation. However, relapsed and refractory MM (RRMM) remains a major challenge. Novel agents and regimens are under active clinical development. These include new PIs such as ixazomib, marizomib, and oprozomib; new MoAbs such as isatuximab and MOR202; novel epigenetic agent ricolinostat and novel cytokines such as siltuximab. Recently, the first XPO-1 inhibitor, selinexor, was approved for RRMM. BCMA-targeted BiTE, antibody–drug conjugates and CAR-T cells have the potential to revolutionize the therapy for RRMM. In this review, we summarized the latest clinical development of these novel agents and regimens.

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Section: Monoclonal Antibodiesmentioning

confidence: 99%

Emerging agents and regimens for multiple myeloma

Yang

et al. 2020

J Hematol Oncol

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“…The anti-SLAMF7 mAb elotuzumab is a very well tolerated drug that can be added to backbone treatments without significant toxicity [35]. Moreover, a subgroup analysis demonstrated similar efficacy across different age and ethnicity groups [36,37].…”

Section: Data On Ndmm Patientsmentioning

confidence: 99%

The Role of Monoclonal Antibodies in the First-Line Treatment of Transplant-Ineligible Patients with Newly Diagnosed Multiple Myeloma

et al. 2020

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Elderly transplant-ineligible (NTE) patients represent the majority of patients affected by multiple myeloma (MM). Elderly patients are a highly heterogeneous population, with large variability in health and functional status. Thus, choosing their optimal treatment is challenging. A wide range of first-line treatments is available, and novel-agent combinations, including monoclonal antibodies (mAbs), have recently entered clinical practice. The combination of the anti-CD38 mAb daratumumab with bortezomib, melphalan and prednisone (Dara-VMP) or lenalidomide and dexamethasone (Dara-Rd) demonstrated impressive advantages in terms of progression-free survival and minimal residual disease negativity, as compared to VMP and Rd, without safety concerns. Another anti-CD38 mAb, isatuximab, is showing encouraging results, and new isatuximab-based combinations might enter clinical practice in the future. Nevertheless, available data come from clinical trials with selected patient populations and, to date, the manageability of these regimens in real-life patients or in frail patients remains unknown. Frailty-tailored treatments, including mAbs, are under evaluation in preliminary studies. In this review, we analyze recently approved mAb-based treatments for NTE newly diagnosed MM patients and new combinations under evaluation, focusing on the efficacy and safety of these regimens and on open issues regarding the choice of therapy for elderly patients.

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“…These RCTs reported 2754 patients with +1q representing 25% of all enrolled patients. Out of 29 RCTs, three trials (10%) specified the criteria for categorizing patients as +1q (for example, in IKEMA and IFM-99: the presence of at least three copies in at least 30% of analyzed plasma cells was required, and in ELOQUENT-2 positivity for 1q was assigned based on identifying at least one abnormal cell) [18][19][20]. Only four trials (14%) reported survival data on gain and amp separately [21][22][23][24], and the remaining 25 (86%) studies reported for gain or did not specify gain versus amp.…”

Section: Reporting Of +1qmentioning

confidence: 99%

Alterations in chromosome 1q in multiple myeloma randomized clinical trials: a systematic review

Neupane,

Fortuna,

Dahal

et al. 2024

Blood Cancer J.

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Extra copies of chromosome 1q21 (+1q: gain = 3 copies, amp >= 4 copies) are associated with worse outcomes in multiple myeloma (MM). This systematic review assesses the current reporting trends of +1q, the efficacy of existing regimens on +1q, and its prognostic implications in MM randomized controlled trials (RCTs). Pubmed, Embase and Cochrane Registry of RCTs were searched from January 2012 to December 2022. Only MM RCTs were included. A total of 124 RCTs were included, of which 29 (23%) studies reported on +1q. Among them, 10% defined thresholds for +1q, 14% reported survival data separately for gain and amp, and 79% considered +1q a high-risk cytogenetic abnormality. Amongst RCTs that met the primary endpoint showing improvement in progression free survival (PFS), lenalidomide maintenance (Myeloma XI), selinexor (BOSTON), and isatuximab (IKEMA and ICARIA) were shown to improve PFS for patients with evidence of +1q. Some additional RCT’s such as Myeloma XI+ (carfilzomib), ELOQUENT-3 (elotuzumab), and HOVON-65/GMMG-HD4 (bortezomib) met their endpoint showing improvement in PFS and also showed improvement in PFS in the +1q cohort, although the confidence interval crossed 1. All six studies that reported HR for +1q patients vs. without (across both arms) showed worse OS and PFS for +1q. There is considerable heterogeneity in the reporting of +1q. All interventions that have shown to be successful in RCTs and have clearly reported on the +1q subgroup have shown concordant direction of results and benefit of the applied intervention. A more standardized approach to reporting this abnormality is needed.

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Elotuzumab plus lenalidomide and dexamethasone for newly diagnosed multiple myeloma: a randomized, open-label, phase 2 study in Japan

Cited by 13 publications

References 32 publications

Emerging agents and regimens for multiple myeloma

Emerging agents and regimens for multiple myeloma

The Role of Monoclonal Antibodies in the First-Line Treatment of Transplant-Ineligible Patients with Newly Diagnosed Multiple Myeloma

Alterations in chromosome 1q in multiple myeloma randomized clinical trials: a systematic review

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