Elotuzumab in Combination With Lenalidomide and Low-Dose Dexamethasone in Relapsed or Refractory Multiple Myeloma

Lonial, Sagar; Vij, Ravi; Harousseau, Jean‐Luc; Façon, Thierry; Moreau, Philippe; Mazumder, Amitabha; Kaufman, Jonathan L.; Leleu, Xavier; Tsao, Lee‐Ing; Westland, Christopher; Singhal, Anil; Jagannath, Sundar

doi:10.1200/jco.2011.37.2649

Cited by 278 publications

(191 citation statements)

References 16 publications

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“…20 The premedication regimen and administration schedule of these medications implemented in studies 1703 and 009 were shown to successfully reduce the number and severity of IRs associated with elotuzumab. 19,22 As a result, this premedication regimen, or an appropriate equivalent, is currently required for all patients prior to infusion of elotuzumab. In the ELOQUENT-2 study, patients received the premedication regimen that had been developed during study 1703.…”

Section: Introductionmentioning

confidence: 99%

A phase 2 safety study of accelerated elotuzumab infusion, over less than 1 h, in combination with lenalidomide and dexamethasone, in patients with multiple myeloma

Berenson

Manges²,

Badarinath

et al. 2017

American J Hematol

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Elotuzumab, an immunostimulatory SLAMF7-targeting monoclonal antibody, induces myeloma cell death with minimal effects on normal tissue. In a previous phase 3 study in patients with relapsed/ refractory multiple myeloma (RRMM), elotuzumab (10 mg/kg, 3-h infusion), combined with lenalidomide and dexamethasone, demonstrated durable efficacy and acceptable safety; 10% (33/321) of patients had infusion reactions (IRs; Grade 1/2: 29; Grade 3: 4). This phase 2 study (NCT02159365) investigated an accelerated infusion schedule in 70 patients with newly diagnosed multiple myeloma or RRMM. The primary endpoint was cumulative incidence of Grade 3/4IRs by completion of treatment Cycle 2. Dosing comprised elotuzumab 10 mg/kg intravenously (weekly, Cycles 1-2; biweekly, Cycles 31), lenalidomide 25 mg (daily, Days 1-21), and dexamethasone (28 mg orally and 8 mg intravenously, weekly, Cycles 1-2; 40 mg orally, weekly, Cycles 31), in 28-day cycles. Premedication with diphenhydramine, acetaminophen, and ranitidine (or their equivalents) was given as in previous studies. If no IRs occurred, infusion rate was increased in Cycle 1 from 0.5 to 2 mL/min during dose 1 ( 2 h 50 min duration) to 5 mL/min for the entire infusion by dose 3 and also during all subsequent infusions ( 1-h duration). Median number of treatment cycles was six. No Grade 3/4 IRs occurred; only one Grade 1 and one Grade 2 IR occurred, both during the first infusion. These data support the safety of a faster infusion of elotuzumab administered over 1 h by the third dose, providing a more convenient alternative dosing option for patients.

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Section: Introductionmentioning

confidence: 99%

A phase 2 safety study of accelerated elotuzumab infusion, over less than 1 h, in combination with lenalidomide and dexamethasone, in patients with multiple myeloma

Berenson

Manges²,

Badarinath

et al. 2017

American J Hematol

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“…Of note, two of 28 treated patients experienced grade 3-4 allergic reactions during elotuzumab first cycle. [23] Those preliminary data supported a randomized phase III trial, which was recently completed. Six hundred and forty-six patients from 168 sites were randomly assigned to receive either elotuzumab, lenalidomide, and dexamethasone, or lenalidomide and dexamethasone.…”

Section: Treatment Of Post Auto-sct Relapsementioning

confidence: 83%

Stem cell transplantation in multiple myeloma and other plasma cell disorders (report from an EBMT preceptorship meeting)

Bruno

Auner

Gahrton

et al. 2016

Leukemia & Lymphoma

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The definitive version is available at: La versione definitiva è disponibile alla URL: [http://www.tandfonline.com.offcampus.dam.unito.it/doi/full/10.3109/10428194.2015.1131278] Stem cell transplantation in multiple myeloma and other plasma cell disorders (report from an EBMT preceptorship meeting) AbstractThe European Society for Blood and Marrow Transplantation Chronic Malignancies Working Party held a preceptorship meeting in Turin, Italy on 25-26 September 2014, to discuss the role of stem cell transplantation (SCT) in the treatment of multiple myeloma and other plasma cell disorders. Scientists and clinicians working in the field gathered to discuss a variety of topics including the results of recent clinical trials, basic research, the concept of minimal residual disease, and immune modulation. As individual presentations revealed, important advances have occurred in our understanding of the pathophysiology of myeloma and the role that SCT, along with other forms of immunotherapy, plays in treating it. Each presentation stimulated discussion and exchange of ideas among the attendants. We decided to summarize and, importantly, to update the meeting proceedings in this review to share stimulating discussions and ideas on potentially novel treatment strategies among clinicians.

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“…By comparison, the anti-CS1 mAb elotuzumab exhibited minimal single-agent activity, without objective responses in a Phase I doseescalation study [50] and has proven to be most promising in combinations with lenalidomide [51] and bortezomib [52]. Indeed, the degree of response observed with DARA at doses of 4 mg/kg and higher is reminiscent of the antitumor activity noted in early studies of single-agent thalidomide (32% with at least a 25% reduction in serum or urine M-protein) [53], lenalidomide (rate of MR or better, 26%) [54] and bortezomib (rate of PR or better, 38%) [55].…”

Section: Expert Opinionmentioning

confidence: 99%

Daratumumab granted breakthrough drug status

Laubach

Tai

Richardson

et al. 2014

Expert Opinion on Investigational Drugs

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Elotuzumab in Combination With Lenalidomide and Low-Dose Dexamethasone in Relapsed or Refractory Multiple Myeloma

Abstract: The combination of elotuzumab, lenalidomide, and low-dose dexamethasone was generally well tolerated and showed encouraging response rates in patients with relapsed or refractory MM.

Cited by 278 publications

References 16 publications

A phase 2 safety study of accelerated elotuzumab infusion, over less than 1 h, in combination with lenalidomide and dexamethasone, in patients with multiple myeloma

A phase 2 safety study of accelerated elotuzumab infusion, over less than 1 h, in combination with lenalidomide and dexamethasone, in patients with multiple myeloma

Stem cell transplantation in multiple myeloma and other plasma cell disorders (report from an EBMT preceptorship meeting)

Daratumumab granted breakthrough drug status

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