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Original Article
- Randomized Phase II Study of Bortezomib, Lenalidomide, and Dexamethasone (VRD) Versus Lenalidomide and Dexamethasone (RD) in Elderly Patients with Newly Diagnosed Multiple Myeloma (KMM1910)
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Jun Ho Yi1
, Sang Eun Yoon1, Ji Hyun Lee2, Soo Mee Bang3, Myung-won Lee4, Joon Ho Moon5, Je-Jung Lee6, Hyeon-Seok Eom7, Chang-Ki Min8, Young Rok Do9, Sungnam Lim10, Ho-Jin Shin11, Jae Hoon Lee12, Hyo Jung Kim13, Sung-Soo Yoon14, Kihyun Kim1
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DOI: https://doi.org/10.4143/crt.2026.0255 [Accepted]
Published online: May 29, 2026
This article has been accepted for publication following full peer review and is provided as an unedited Accepted Article to allow early access to its findings. It has not yet undergone copyediting, typesetting, pagination, or proofreading, and the final Version of Record may differ from this version.
1Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
2Division of Hematology-Oncology, Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea
3Division of Hematology-Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea
4Division of Hematology-Oncology, Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Korea
5Division of Hematology-Oncology, Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea
6Division of Hematology-Oncology, Department of Internal Medicine, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Hwasun, Korea
7Center for Hematologic Malignancy, National Cancer Center, Goyang, Korea
8Department of Hematology, Catholic Hematology Hospital, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
9Division of Hematology-Oncology, Department of Internal Medicine, Dongsan Medical Center, Keimyung University, Daegu, Korea
10Division of Hematology-Oncology, Department of Internal Medicine, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea
11Division of Hematology-Oncology, Department of Internal Medicine, Pusan National University Hospital, Pusan National University School of Medicine, Busan, Korea
12Division of Hematology-Oncology, Department of Internal Medicine, Gachon University Medical College, Gachon University Gil Medical Center, Incheon, Korea
13Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Korea
14Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea
2Division of Hematology-Oncology, Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea
3Division of Hematology-Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea
4Division of Hematology-Oncology, Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Korea
5Division of Hematology-Oncology, Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea
6Division of Hematology-Oncology, Department of Internal Medicine, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Hwasun, Korea
7Center for Hematologic Malignancy, National Cancer Center, Goyang, Korea
8Department of Hematology, Catholic Hematology Hospital, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
9Division of Hematology-Oncology, Department of Internal Medicine, Dongsan Medical Center, Keimyung University, Daegu, Korea
10Division of Hematology-Oncology, Department of Internal Medicine, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea
11Division of Hematology-Oncology, Department of Internal Medicine, Pusan National University Hospital, Pusan National University School of Medicine, Busan, Korea
12Division of Hematology-Oncology, Department of Internal Medicine, Gachon University Medical College, Gachon University Gil Medical Center, Incheon, Korea
13Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Korea
14Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea
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Corresponding author:
Kihyun Kim
Tel: 82-2-3410-3456
Email: kihyunk@skku.edu
- Jun Ho Yi and Sang Eun Yoon contributed equally to this work.
Received: 11 March 2026 • Accepted: 28 May 2026
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Abstract
Purpose
While triplet regimens are considered optimal for treatment of multiple myeloma (MM), the benefit of adding bortezomib to lenalidomide and dexamethasone remains prospective-wise unclear in elderly patients due to frailty and potential toxicities.
Materials and Methods
This multicenter, randomized phase II study evaluated the efficacy and safety of bortezomib/lenalidomide/dexamethasone (VRd) versus Rd (lenalidomide/ dexamethasone) in transplant-ineligible patients aged ≥ 70 years.
Results
Forty-nine patients were randomized to receive either VRd or Rd. The overall response rates were comparable between two arms (72.7% for Rd and 84.6% for VRd, p=0.312). Although VRd achieved a significantly higher minimal residual disease negativity rate compared to Rd (76.9% vs. 12.5%, p=0.004), this deeper response did not translate into a statistically significant improvement in the primary endpoint, the 3-year progression-free survival rate, which was 53.8% for VRd and 45.5% for Rd (p=0.520). Similarly, no significant difference was observed in overall survival OS between the two arms. Safety analysis revealed that grade 3–4 adverse events were comparable, occurring in 73.1% of the VRd arm and 77.3% of the Rd arm. Notably, infections were a major cause of treatment discontinuation and mortality, accounting for seven deaths overall.
Conclusion
While VRd induced numerically deeper responses, its clinical benefit in a real-world-representative elderly population may be limited by treatment tolerability and infection risks.
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