A phase 1, multicenter, open-label, dose escalation study of elotuzumab in patients with advanced multiple myeloma

Zonder, Jeffrey A.; Mohrbacher, Ann F.; Singhal, Seema; van Rhee, Frits; Bensinger, William I.; Ding, Han; Fry, John; Afar, Daniel E. H.; Singhal, Anil K.

doi:10.1182/blood-2011-06-360552

Cited by 342Multiple Myeloma Research and TreatmentsMonoclonal and Polyclonal Antibodies ResearchChronic Lymphocytic Leukemia Research

A phase 1, multicenter, open-label, dose escalation study of elotuzumab in patients with advanced multiple myeloma

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Zonder, Jeffrey A., Mohrbacher, Ann F., Singhal, Seema, van Rhee, Frits, Bensinger, William I., Ding, Han, Fry, John, Afar, Daniel E. H. +1 more·2012·Blood

DOI 10.1182/blood-2011-06-360552PMC PMC4467882

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Abstract

This multicenter, first-in-human study evaluated the safety, tolerability, and pharmacokinetic and pharmacodynamic properties of the anti-CS1 monoclonal antibody elotuzumab. A standard 3 + 3 design was used to determine maximum tolerated dose; dose-limiting toxicities were assessed during cycle 1. Thirty-five patients with relapsed/refractory multiple myeloma were treated with intravenous elotuzumab at doses ranging from 0.5 to 20 mg/kg every 2 weeks. Patients who achieved at least stable disease after 4 treatments could receive another 4 treatments. No maximum tolerated dose was identified up to the maximum planned dose of 20 mg/kg. The most common adverse events, regardless of attribution, were cough, headache, back pain, fever, and chills. Adverse events were generally mild to moderate in severity, and adverse events attributed to study medication were primarily infusion-related. Plasma elotuzumab levels and terminal half-life increased with dose whereas clearance decreased, suggesting target-mediated clearance. CS1 on bone marrow–derived plasma cells was reliably saturated (≥ 95%) at the 10-mg/kg and 20-mg/kg dose levels. Using the European Group for Bone and Marrow Transplantation myeloma response criteria, 9 patients (26.5%) had stable disease. In summary, elotuzumab was generally well tolerated in this population, justifying further exploration of this agent in combination regimens.

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Elotuzumab has no anti-myeloma activity as monotherapy, but the addition of elotuzumab to lenalidomide or pomalidomide and dexamethasone improved ORRs, PFS and OS in patients with R/R MM.
“The anti-SLAMF7 antibody elotuzumab has no anti-myeloma activity as monotherapy65, but the addition of this agent to lenalidomide or pomalidomide and dexamethasone improved ORRs, PFS and OS in patients with R/R MM47,66,67.”
From Cancer therapies based on targeted protein degradation — lessons learned with lenalidomide (2021) · cites this paper as [66]

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Phase I Study of Elotuzumab (HuLuc63) in Phase I Study of Elotuzumab (HuLuc63) in Relapsed/Refractory Multiple Myeloma
Zonder, J. A., Singhal, S., Bensinger, W., Mohrbacher, A., Hussein, M. A., Munshi, N. C., Caras, I. W., Singhal, A. K., & van Rhee, F. (2008) · Blood · doi:10.1182/blood.v112.11.2773.2773 · Cited by 10 · see citing works
Self-citation
Phase I Trial of Anti-CS1 Monoclonal Antibody Elotuzumab in Combination With Bortezomib in the Treatment of Relapsed/Refractory Multiple Myeloma
Jakubowiak, A. J., Benson, D. M., Bensinger, W., Siegel, D. S. D., Zimmerman, T. M., Mohrbacher, A., Richardson, P. G. G., Afar, D., Singhal, A. K., & Anderson, K. C. (2012) · Journal of Clinical Oncology · doi:10.1200/jco.2011.37.7069 · Cited by 204 · see citing works
Self-citation
Elotuzumab: a novel anti-CS1 monoclonal antibody for the treatment of multiple myeloma
Lonial, S., Kaufman, J. L., Laubach, J. P., & Richardson, P. G. G. (2013) · Expert Opinion on Biological Therapy · doi:10.1517/14712598.2013.847919 · Cited by 33 · see citing works
Elotuzumab in combination with bortezomib in patients with relapsed/refractory multiple myeloma: A phase I study.
Jakubowiak, A. J., Benson, D. M., Bensinger, W., Siegel, D. S. D., Zimmerman, T. M., Mohrbacher, A., Richardson, P. G. G., Afar, D., Singhal, A. K., & Anderson, K. C. (2010) · Journal of Clinical Oncology · doi:10.1200/jco.2010.28.15_suppl.8003 · Cited by 8 · see citing works
Self-citation
Phase I trial of elotuzumab, lenalidomide, and low-dose dexamethasone in patients with relapsed or refractory multiple myeloma.
Lonial, S., Vij, R., Facon, T. T. F., Moreau, P., Leleu, X. P., Mazumder, A., Kaufman, J. L., Westland, C., Tsao, C., Singhal, A. K., et al. (2011) · Journal of Clinical Oncology · doi:10.1200/jco.2011.29.15_suppl.8076 · Cited by 6 · see citing works
Self-citation

Authors: Zonder, J. A., Mohrbacher, A. F., Singhal, S., van Rhee, F., Bensinger, W. I., Ding, H., Fry, J., Afar, D. E. H., & Singhal, A. K.
Affiliations: Wayne State University (US)
University of Southern California (US)
Northwestern University (US)
Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences, Little Rock, AR;
Fred Hutch Cancer Center (US)
AbbVie Biotherapeutics (United States) (US)
ORCID: Zonder, Jeffrey A.
Mohrbacher, Ann F.
Singhal, Seema
Ding, Han
Fry, John
Venue: Blood
Publisher: American Society of Hematology
Published: 2012-07-19
Volume: 120
Issue: 3
Pages: 552-559
ISSN: 0006-4971 (ISSN-L)
1528-0020
DOI: 10.1182/blood-2011-06-360552
PMC: PMC4467882
OpenAlex: W2000130439
Cited by: 342
References: 42
Citations by year: 2026: 3 · 2025: 2 · 2024: 8 · 2023: 10 · 2022: 16 · 2021: 22 · 2020: 34 · 2019: 25 · 2018: 42 · 2017: 41 · 2016: 48 · 2015: 38 · 2014: 28 · 2013: 21 · 2012: 4
FWCI: 11.63
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: Blood (publishedVersion)
Europe PMC (PubMed Central) (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Funders: Bristol-Myers Squibb
National Cancer Institute (P01CA055819)
Topics: Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
Health Sciences › Medicine › Genetics › Chronic Lymphocytic Leukemia Research
Keywords: elotuzumab, multiple myeloma, CS1, syndecan-1, monoclonal antibodies, dose escalation, maximum tolerated dose, dose-limiting toxicity, pharmacokinetics, pharmacodynamics, safety and tolerability, relapsed/refractory multiple myeloma, stable disease
MeSH terms: Aged, Aged, 80 and over, Antineoplastic Agents, Bone Marrow, Dose-Response Relationship, Drug, Female, Humans, Male, Middle Aged, Multiple Myeloma, Severity of Illness Index, Treatment Outcome, Lymphocyte Count, Chemokine CXCL10, Antibodies, Neutralizing, Antibodies, Monoclonal, Humanized

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A phase 1, multicenter, open-label, dose escalation study of elotuzumab in patients with advanced multiple myeloma

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