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Article

Daratumumab Improves Bone Turnover in Relapsed/Refractory Multiple Myeloma; Phase 2 Study “REBUILD”

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Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, 11528 Athens, Greece
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First Department of Internal Medicine, School of Medicine, AHEPA University Hospital, Aristotle University of Thessaloniki, 54124 Thessaloniki, Greece
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Department of Hematology, Theagenio Cancer Hospital, 54639 Thessaloniki, Greece
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Health Data Specialists S.A., 11525 Athens, Greece
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Bone Marrow Transplantation Unit and Department of Hematology, Evangelismos Hospital, 10676 Athens, Greece
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First Department of Propedeutic Internal Medicine, School of Medicine, National and Kapodistrian University of Athens, 11527 Athens, Greece
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Hematology Division, Department of Internal Medicine, School of Medicine, University of Patras, 26334 Patras, Greece
*
Author to whom correspondence should be addressed.
Academic Editor: Taketo Yamada
Cancers 2022, 14(11), 2768; https://doi.org/10.3390/cancers14112768
Received: 26 April 2022 / Revised: 29 May 2022 / Accepted: 30 May 2022 / Published: 2 June 2022
(This article belongs to the Section Cancer Therapy)
Multiple myeloma (MM) is characterized by the presence of deregulated bone metabolism. Restoring bone turnover is essential for patients with MM. We prospectively evaluated the impact of the anti-CD38 monoclonal antibody daratumumab on markers of bone remodeling among patients with relapsed/refractory MM. Overall, daratumumab improved bone turnover by favoring bone formation.
Biomarkers of bone turnover in serum are suggestive of bone dynamics during treatment in multiple myeloma (MM). We evaluated the role of daratumumab on bone remodeling among patients with relapsed/refractory MM in the prospective, open-label, phase 2 study REBUILD. Daratumumab was administered according to the approved indication. A total of 33 out of 57 enrolled patients completed 4 months of treatment. The median percent change from baseline to 4 months in C-terminal cross-linking telopeptide of type 1 collagen (CTX) (primary endpoint) was 3.9%, with 13 (39.4%) and 11 (33.3%) patients showing at least 20% and 30% reduction in CTX levels, respectively. The median percent decrease from baseline to 4 months in tartrate resistant acid phosphatase 5b (TRACP-5b) levels (co-primary endpoint) was 2.6%, with 10 (30.3%) and 6 (18.2%) patients showing at least 20% and 30% reduction in TRACP-5b levels, respectively. However, the changes in these markers of bone catabolism were not statistically significant. Furthermore, the levels of osteocalcin, bone-specific alkaline phosphatase and procollagen type-I N-pro-peptide (bone formation markers) increased from baseline to 4 months (secondary endpoints) by 18.4%, 92.6% and 10.2%, respectively. Furthermore, the median levels of dickkopf-1 and C-C motif ligand-3 showed a significant decrease at 4 months by 17.5% and 16.0%, respectively. In conclusion, daratumumab improved bone turnover by inducing bone formation and reducing osteoblast inhibition. View Full-Text
Keywords: multiple myeloma; daratumumab; bone metabolism; biomarker; clinical trial multiple myeloma; daratumumab; bone metabolism; biomarker; clinical trial
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MDPI and ACS Style

Terpos, E.; Ntanasis-Stathopoulos, I.; Kastritis, E.; Hatjiharissi, E.; Katodritou, E.; Eleutherakis-Papaiakovou, E.; Verrou, E.; Gavriatopoulou, M.; Leonidakis, A.; Manousou, K.; Delimpasi, S.; Malandrakis, P.; Kyrtsonis, M.-C.; Papaioannou, M.; Symeonidis, A.; Dimopoulos, M.-A. Daratumumab Improves Bone Turnover in Relapsed/Refractory Multiple Myeloma; Phase 2 Study “REBUILD”. Cancers 2022, 14, 2768. https://doi.org/10.3390/cancers14112768

AMA Style

Terpos E, Ntanasis-Stathopoulos I, Kastritis E, Hatjiharissi E, Katodritou E, Eleutherakis-Papaiakovou E, Verrou E, Gavriatopoulou M, Leonidakis A, Manousou K, Delimpasi S, Malandrakis P, Kyrtsonis M-C, Papaioannou M, Symeonidis A, Dimopoulos M-A. Daratumumab Improves Bone Turnover in Relapsed/Refractory Multiple Myeloma; Phase 2 Study “REBUILD”. Cancers. 2022; 14(11):2768. https://doi.org/10.3390/cancers14112768

Chicago/Turabian Style

Terpos, Evangelos, Ioannis Ntanasis-Stathopoulos, Efstathios Kastritis, Evdoxia Hatjiharissi, Eirini Katodritou, Evangelos Eleutherakis-Papaiakovou, Evgenia Verrou, Maria Gavriatopoulou, Alexandros Leonidakis, Kyriaki Manousou, Sosana Delimpasi, Panagiotis Malandrakis, Marie-Christine Kyrtsonis, Maria Papaioannou, Argiris Symeonidis, and Meletios-Athanasios Dimopoulos. 2022. "Daratumumab Improves Bone Turnover in Relapsed/Refractory Multiple Myeloma; Phase 2 Study “REBUILD”" Cancers 14, no. 11: 2768. https://doi.org/10.3390/cancers14112768

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