Bortezomib with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in patients with newly diagnosed myeloma without intent for immediate autologous stem-cell transplant (SWOG S0777): a randomised, open-label, phase 3 trial
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Summary Background Lenalidomide plus dexamethasone is a reference treatment for patients with newly diagnosed myeloma. The combination of the proteasome inhibitor bortezomib with lenalidomide and dexamethasone has shown significant efficacy in the setting of newly diagnosed myeloma. We aimed to study whether the addition of bortezomib to lenalidomide and dexamethasone would improve progression-free survival and provide better response rates in patients with previously untreated multiple myeloma who were not planned for immediate autologous stem-cell transplant. Methods In this randomised, open-label, phase 3 trial, we recruited patients with newly diagnosed multiple myeloma aged 18 years and older from participating Southwest Oncology Group (SWOG) and National Clinical Trial Network (NCTN) institutions (both inpatient and outpatient settings). Key inclusion criteria were presence of CRAB (C=calcium elevation; R=renal impairment; A=anaemia; B=bone involvement) criteria with measurable disease (measured by assessment of free light chains), Eastern Cooperative Oncology Group (ECOG) performance status of 0–3, haemoglobin concentration 9 g/dL or higher, absolute neutrophil count 1 × 103 cells per mm3; or higher, and a platelet count of 80 000/mm3 or higher. We randomly assigned (1:1) patients to receive either an initial treatment of bortezomib with lenalidomide and dexamethasone (VRd group) or lenalidomide and dexamethasone alone (Rd group). Randomisation was stratified based on International Staging System stage (I, II, or III) and intent to transplant (yes vs no). The VRd regimen was given as eight 21-day cycles. Bortezomib was given at 1·3 mg/m2 intravenously on days 1, 4, 8, and 11, combined with oral lenalidomide 25 mg daily on days 1–14 plus oral dexamethasone 20 mg daily on days 1, 2, 4, 5, 8, 9, 11, and 12. The Rd regimen was given as six 28-day cycles. The standard Rd regimen consisted of 25 mg oral lenalidomide once a day for days 1–21 plus 40 mg oral dexamethasone once a day on days 1, 8, 15, and 22. The primary endpoint was progression-free survival using a prespecified one-sided stratified log rank test at a significance level of 0·02. Analyses were intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00644228. Findings Between April, 2008, and February, 2012, we randomly assigned 525 patients at 139 participating institutions (264 to VRd and 261 to Rd). In the randomly assigned patients, 21 patients in the VRd group and 31 in the Rd group were deemed ineligible based mainly on missing, insufficient, or early or late baseline laboratory data. Median progression-free survival was significantly improved in the VRd group (43 months vs 30 months in the Rd group; stratified hazard ratio [HR] 0·712, 96% CI 0·56–0·906; one-sided p value 0·0018). The median overall survival was also significantly improved in the VRd group (75 months vs 64 months in the Rd group, HR 0·709, 95% CI 0·524–0·959; two-sided p value 0·025). The rates of overall response (partial response or better) were 82% (176/216) in the VRd group and 72% (153/214) in the Rd group, and 16% (34/216) and 8% (18/214) of patients who were assessable for response in these respective groups had a complete response or better. Adverse events of grade 3 or higher were reported in 198 (82%) of 241 patients in the VRd group and 169 (75%) of 226 patients in the Rd group; 55 (23%) and 22 (10%) patients discontinued induction treatment because of adverse events, respectively. There were no treatment-related deaths in the Rd group, and two in the VRd group. Interpretation In patients with newly diagnosed myeloma, the addition of bortezomib to lenalidomide and dexamethasone resulted in significantly improved progression-free and overall survival and had an acceptable risk-benefit profile. Funding NIH, NCI, NCTN, Millennium Pharmaceuticals, Takeda Oncology Company, and Celgene Corporation.
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For patients older than 75, median overall survival is about 5 years.
“Among elderly patients (age >75 years), median OS is lower, and is approximately 5 years.46,47”
From Multiple myeloma: 2024 update on diagnosis, risk-stratification, and management (2024) · cites this paper as [46]
The Results report median overall survival of 63 months—about five years—for patients older than 75 receiving VRd. But the median was 31 months for patients in that age group receiving Rd, so the paper does not support an unqualified five-year median for all patients older than 75. (LLM, conf=0.88)
Experimental — accuracy not yet measuredThe phase 3 SWOG S0777 trial showed that adding bortezomib to lenalidomide plus dexamethasone lengthened progression-free survival in newly diagnosed myeloma patients not immediately eligible for autologous stem-cell transplantation (median, 41 vs. 29 months; hazard ratio, 0.74).
“The phase 3 Southwest Oncology Group (SWOG) S0777 trial of lenalidomide plus dexamethasone with or without bortezomib in patients with newly diagnosed myeloma for whom immediate autologous stem-cell transplantation was not indicated showed that the triplet combination resulted in longer progression-free survival (median, 41 months vs. 29 months; hazard ratio, 0.74), including among patients who”
From Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma (2019) · cites this paper as [4]
Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredVRd has shown a survival benefit compared with Rd.
“An alternative regimen is VRd which has also shown a survival benefit compared with Rd (Table 7).46”
From Multiple myeloma: 2024 update on diagnosis, risk-stratification, and management (2024) · cites this paper as [46]
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- Authors
- Durie, B. G. M., Hoering, A., Abidi, M. H., Rajkumar, S. V., Epstein, J., Kahanic, S. P., Thakuri, M., Reu, F., Reynolds, C. M., Sexton, R., Orlowski, R. Z., Barlogie, B., & Dispenzieri, A.
- Affiliations
- Cedars-Sinai Medical Center (US)
- Cancer Research And Biostatistics (US)
- Spectrum Health (US)
- Mayo Clinic (US)
- University of Arkansas for Medical Sciences (US)
- June E. Nylen Cancer Center (US)
- Southeast Clinical Oncology Research Consortium (US)
- Cleveland Clinic (US)
- Trinity Health Ann Arbor Hospital (US)
- The University of Texas MD Anderson Cancer Center (US)
- Icahn School of Medicine at Mount Sinai (US)
- Corresponding author
- Durie, Brian G M
- ORCID
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2017-02
- Volume
- 389
- Issue
- 10068
- Pages
- 519-527
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- PMC
- PMC5546834
- OpenAlex
- W2567188480
- Semantic Scholar
- 7647868cd95b604909a1136633cab96735a780ba
- Cited by
- 908
- References
- 36
- Citations by year
- 2026: 53 · 2025: 75 · 2024: 87 · 2023: 78 · 2022: 89 · 2021: 131 · 2020: 137 · 2019: 110 · 2018: 90 · 2017: 53 · 2016: 3
- FWCI
- 81.21
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (UL1TR000371)
- National Cancer Institute (U10CA016385, U10CA004919, UG1CA189821, UG1CA189829, UG1CA189953, UG1CA189808, U10CA139519, U10CA180820, UG1CA189952, R01CA126448, UG1CA189957, U10CA068183, UG1CA189825, N01 CA004919, UG1CA189853, U10CA180888, UG1CA189830, U10CA073590, UG1CA189854, U10CA180819, UG1CA189804, UG1CA189971, U10CA013612, U10CA022433, U10CA046282, UG1CA189856, UG1CA189860, U10CA045450, U10CA046113, U10CA012644, N01 CA013612, UG1CA189858, U10CA037981, U10CA180821, UG1CA189872, P30CA015083, P50CA186781)
- National Institute of Nursing Research (F31NR016385)
- National Institute of Neurological Disorders and Stroke (R01NS035996)
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (R41AR068183, RC1AR058723)
- National Center for Research Resources (S10RR022433)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
- Health Sciences › Medicine › Oncology › Bone health and treatments
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Amyloidosis: Diagnosis, Treatment, Outcomes
- Keywords
- bortezomib, lenalidomide, dexamethasone, newly diagnosed multiple myeloma, proteasome inhibitors, autologous stem cell transplantation, progression-free survival, CRAB criteria, treatment response, International Staging System stage
- MeSH terms
- Bortezomib, Lenalidomide, Adult, Aged, Antineoplastic Agents, Dexamethasone, Drug Therapy, Combination, Female, Humans, Male, Middle Aged, Multiple Myeloma, Thalidomide, Survival Rate, Treatment Outcome, Hematopoietic Stem Cell Transplantation, Disease-Free Survival, Angiogenesis Inhibitors
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