Siltuximab (CNTO 328) with lenalidomide, bortezomib and dexamethasone in newly-diagnosed, previously untreated multiple myeloma: an open-label phase I trial
Open accessAbstract
The safety and efficacy of siltuximab (CNTO 328) was tested in combination with lenalidomide, bortezomib and dexamethasone (RVD) in patients with newly-diagnosed, previously untreated symptomatic multiple myeloma. Fourteen patients were enrolled in the study, eleven of whom qualified to receive therapy. A majority of patients (81.8%) completed the minimal number or more of the four required cycles, while two patients completed only three cycles. The maximum tolerated dose (MTD) of siltuximab with RVD was dose level −1 (siltuximab: 8.3 mg/kg; bortezomib: 1.3 mg/m 2; lenalidomide: 25 mg; dexamethasone: 20 mg). Serious adverse events were grade 3 pneumonia and grade 4 thrombocytopenia, and no deaths occurred during the study or with follow-up (median follow-up 28.1 months). An overall response rate, after 3–4 cycles of therapy, of 90.9% (95% confidence interval (CI): 58.7%, 99.8%) (9.1% complete response (95% CI: 0.2%, 41.3%), 45.5% very good partial response (95% CI: 16.7%, 76.6%) and 36.4% partial response (95% CI: 10.9%, 69.2%)) was seen. Two patients withdrew consent, and nine patients (81.8%) opted for autologous stem cell transplantation.
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Siltuximab combined with lenalidomide, bortezomib, and dexamethasone in newly diagnosed MM showed an ORR of 90.9%, with 45.5% VGPR and 36.4% PR compared to VRD alone.
“In an open-label phase I trial, the combination of Siltuximab with lenalidomide, bortezomib, and dexamethasone (VRD) for newly-diagnosed multiple myeloma (NDMM) showed an overall response rate (ORR) of 90.9%, with 45.5% very good partial response (VGPR) and 36.4% partial response (PR) compared to VRD alone [114].”
From Multiple myeloma: signaling pathways and targeted therapy (2024) · cites this paper as [114]
The Abstract and Results > Treatment efficacy report the stated 90.9% overall response rate, 45.5% VGPR rate, and 36.4% PR rate for siltuximab plus RVD. The study had no RVD-alone arm: the Discussion says only that the VGPR rate was higher than expected for RVD alone, so the claimed comparison is not supported as a direct trial result. Page numbers are not provided in our copy. (LLM, conf=0.88)
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Multiple myeloma: signaling pathways and targeted therapy
Lu, Q., Yang, D., Li, H., Niu, T., & Tong, A. (2024) · Molecular biomedicine · doi:10.1186/s43556-024-00188-w · Cited by 90 · see citing works
- Authors
- Shah, J. J., Feng, L., Thomas, S. K., Berkova, Z., Weber, D. M., Wang, M., Qazilbash, M. H., Champlin, R. E., Mendoza, T. R., Cleeland, C., & Orlowski, R. Z.
- Affiliations
- The University of Texas MD Anderson Cancer Center (US)
- Corresponding author
- Shah, J J
- Venue
- Blood Cancer Journal
- Published
- 2016-02-12
- Volume
- 6
- Issue
- 2
- Pages
- e396-e396
- ISSN
- 2044-5385 (ISSN-L)
- PMC
- PMC4771967
- OpenAlex
- W2261372666
- Cited by
- 35
- References
- 0
- Citations by year
- 2026: 4 · 2025: 2 · 2024: 4 · 2023: 3 · 2022: 1 · 2021: 1 · 2020: 3 · 2019: 5 · 2018: 8 · 2017: 1 · 2016: 3
- FWCI
- 5.36
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Blood Cancer Journal (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Funders
- National Cancer Institute (CA194264, CA-32102, R01CA102278, R01CA194264, P50CA142509, CA184464, U10CA032102, R01CA184464, CA142509, P30CA016672)
- Topics
- Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
- Health Sciences › Medicine › Oncology › Bone health and treatments
- Health Sciences › Medicine › Pathology and Forensic Medicine › Lymphoma Diagnosis and Treatment
- Keywords
- siltuximab, lenalidomide, bortezomib, dexamethasone, newly diagnosed multiple myeloma, maximum tolerated dose, treatment safety, treatment efficacy, autologous stem cell transplantation, complete response, very good partial response, partial response, pneumonia, thrombocytopenia
- MeSH terms
- Bortezomib, Lenalidomide, Aged, Antibodies, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, Chromosome Aberrations, Dexamethasone, Female, Humans, Male, Middle Aged, Multiple Myeloma, Neoplasm Staging, Quality of Life, Thalidomide, Treatment Outcome, Disease Progression, Maximum Tolerated Dose
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