Optimizing quadruplet therapy for older patients with newly diagnosed multiple myeloma: lessons from the REST trial
Editorial Commentary

Optimizing quadruplet therapy for older patients with newly diagnosed multiple myeloma: lessons from the REST trial

Kazuhito Suzuki ORCID logo

Division of Clinical Oncology/Hematology, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan

Correspondence to: Kazuhito Suzuki, MD, PhD. Division of Clinical Oncology/Hematology, Department of Internal Medicine, The Jikei University School of Medicine, 3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo 105-0003, Japan. Email: kaz-suzuki@jikei.ac.jp.

Comment on: Askeland FB, Haukås E, Slørdahl TS, et al. Isatuximab, bortezomib, lenalidomide, and limited dexamethasone in patients with transplant-ineligible multiple myeloma (REST): a multicentre, single-arm, phase 2 trial. Lancet Haematol 2025;12:e120-7.

Keywords: Multiple myeloma; elderly; quadruplet regimen; bortezomib; dexamethasone

Received: 06 January 2026; Accepted: 10 March 2026; Published online: 24 March 2026.

doi: 10.21037/aob-2026-1-0002

Multiple myeloma remains an incurable hematological malignancy. However, survival outcomes have improved markedly with the advent of proteasome inhibitors, immunomodulatory drugs (IMiDs), and anti-CD38 monoclonal antibodies. Autologous stem cell transplantation (ASCT) has long been regarded as a standard therapeutic option, and first-line treatment strategies have traditionally been stratified according to transplant eligibility. Recently, quadruplet induction regimens incorporating agents from three major drug classes have become standard, irrespective of transplant eligibility, with the expectation of further improving treatment outcomes.

Minimal residual disease (MRD) negativity has been established as a surrogate marker of long-term survival, and an increasing number of clinical trials have adopted MRD negativity as the primary endpoint. Although ASCT contributes to higher MRD-negative rates, the clinical value of upfront transplantation in patients who have already achieved MRD negativity remains controversial. Although quadruplet regimens demonstrate superior efficacy compared to triplet therapies, they are also associated with a higher incidence of severe adverse events, necessitating careful safety considerations. Moreover, most quadruplet trials have excluded patients aged 80 years or older, leaving limited evidence regarding the efficacy and tolerability of these regimens in very elderly patients.

From a mechanistic perspective, combining an anti-CD38 monoclonal antibody with an IMiD and a proteasome inhibitor offers several theoretical advantages. The combination of anti-CD38 monoclonal antibodies and IMiDs enhances immune activation (1,2). In addition, bortezomib enhances natural killer (NK) cell activity (3) and augments interferon-γ and perforin production, as well as sustained antitumor activity, when NK cells are exposed to daratumumab plus bortezomib in mice (4). Furthermore, both lenalidomide and bortezomib upregulated CD38 expression in myeloma cells by suppressing IKZF1/3, with the combination inducing the highest levels (5). Proteasome inhibitors promote immunogenic cell death by releasing HMGB1 and ANXA1 (6). Collectively, these mechanisms provide a strong biological rationale for quadruplet therapy, which incorporates three drug classes.

The REST (Replacing Steroids in the Transplant Ineligible) trial is a phase 2 study evaluating isatuximab plus bortezomib, lenalidomide, and limited dexamethasone (IsaVRd) in newly diagnosed, transplant-ineligible patients with multiple myeloma, including a substantial proportion of very elderly individuals (7). Patients received isatuximab at 10 mg/kg weekly during cycle 1 and biweekly from cycles 2 to 18; bortezomib at 1.3 mg/m2 on days 1, 8, and 15 for cycles 1–8; lenalidomide at 25 mg on days 1–21 until disease progression; and dexamethasone 20 mg only during cycles 1 and 2. Each cycle was 28 days. The median age was 77 years (range, 70–88 years), and 31% of patients were aged 80 years or older. Eligibility criteria were largely consistent with those of previous studies, except for the inclusion of patients with a performance status (PS) of 3, which accounted for only 6% of the cohort. Frailty was present in 45% of the study population. High-risk cytogenetic abnormalities were present in 18% of patients according to conventional criteria and in 31% according to the new International Myeloma Society (IMS)/International Myeloma Working Group (IMWG) high-risk criteria; t(11;14) was observed in 22%. At a median follow-up of 27 months, the median progression-free survival (PFS) and overall survival (OS) were not achieved, and the median treatment duration was 22 months. The most common adverse events were neutropenia, infections, and thrombocytopenia. Serious adverse events occurred in 53% of the patients. Two patients discontinued treatment before completing 19 cycles because of adverse events (one due to cytomegalovirus infection and one due to muscle and joint pain), and two treatment-related deaths (one from pneumonia and one from sepsis) were observed. The median relative dose intensities (RDIs) were high for isatuximab (97%) and bortezomib (96%), moderate for lenalidomide (83%), and complete for dexamethasone (100%). Overall, the REST trial showed a good balance between the efficacy and safety of the modified IsaVRd in transplant-ineligible patients with multiple myeloma, including those aged >80 years.

The IMROZ trial is one of the largest studies to compare IsaVRd and VRd in transplant-ineligible patients with multiple myeloma. The IsaVRd schedule in the IMROZ trial was conventional; bortezomib was administered twice weekly during cycles 1–8, and isatuximab, lenalidomide, and dexamethasone were continued until disease progression or unacceptable toxicity occurred (8). Although direct cross-trial comparisons are inappropriate, the PFS curve for frail patients in the REST trial appeared comparable to that observed in frail patients in the IMROZ trial (9). Notably, early non-disease-related mortality in frail patients exceeded 10% within the first 6 months in both treatment arms of the IMROZ trial and was possibly higher than that observed in the REST trial. Weekly bortezomib dosing, as used in REST, has been shown to reduce peripheral neuropathy, a critical consideration given its detrimental impact on the quality of life in older patients (10).

In the MAIA trial, daratumumab plus lenalidomide and dexamethasone (DRd) demonstrated superiority over lenalidomide and dexamethasone (Rd) in terms of PFS, even in frail patients and those aged ≥80 years. Although no OS difference was observed in the ≥80-year subgroup, this finding is unsurprising because lenalidomide and dexamethasone alone already achieved a median OS of approximately 4 years, approaching the expected life expectancy in this age group (11). Although the results of the REST trial cannot be directly compared with those of the MAIA trial, given that 12.8% of frail patients in the MAIA trial discontinued treatment within 12 months, the discontinuation rate in the REST trial may be lower. Importantly, the discontinuation rate among frail patients in the MAIA trial was higher for Rd therapy than for DRd therapy, although the adverse events leading to discontinuation were not clearly characterized. However, the risk of infection in multiple myeloma is high during the initial months of treatment, reflecting an immunosuppressed state during the unstable phase of the disease (12,13). Achieving a therapeutic response to treatment, including anti-CD38 antibody therapy, even in frail patients, might reduce treatment discontinuation due to adverse events, including infections (13,14). Thus, the IsaVRd regimen schedule used in the REST trial was considered reasonable even for elderly and frail patients under close monitoring for adverse events. By contrast, the RDI for lenalidomide in patients aged 80 years or older receiving DRd therapy was 61.8% in the MAIA trial (15), which differed from the RDI for lenalidomide in the REST trial, although the reason for this difference remains unclear.

The BENEFIT trial, like the IMROZ trial, enrolled patients under 80 years of age, but the BOR schedule consisted of administration on days 1, 8, and 15 in cycles 1–8 and days 1 and 15 in cycles 9–18 (16). The difference in dosing schedules between the BENEFIT and REST trials was that bortezomib was continued beyond cycle 9, and isatuximab was continued beyond cycle 19 in the BENEFIT trial. Another key finding of the BENEFIT trial was that the control group received isatuximab plus Rd (IsaRd) therapy. The primary endpoint, MRD negativity rate, was significantly higher for IsaVRd than for IsaRd therapy. The MRD negativity rates for DRd and IsaRd were similar, although the therapies were not entirely equivalent. However, the MRD negativity rate with IsaVRd was significantly higher than that with IsaRd, suggesting that a four-drug combination, including bortezomib, is superior to anti-CD38 antibody therapy plus Rd in transplant-ineligible patients with multiple myeloma, given that MRD negativity may serve as a surrogate marker for PFS. Although PFS in the BENEFIT trial was immature, it may have been superior to that observed in the REST trial. In the ALCYONE trial, PFS declined sharply in the daratumumab plus bortezomib, melphalan, and prednisone (VMP) therapy groups after bortezomib discontinuation at 12 months (17). According to a matched-pair analysis of VMP therapy in the VISTA and PETHEMA/GEM05 trials, the cumulative bortezomib dose correlated with survival duration (18). These two pieces of evidence suggest that increasing the cumulative dose by administering bortezomib less frequently could not only reduce toxicity but also improve clinical outcomes. Therefore, discontinuing bortezomib after cycle 9 in IsaVRd therapy remains an open question in patients aged 80 years or older.

The fixed duration of isatuximab in transplant-ineligible myeloma remains controversial, as anti-CD38 monoclonal antibodies are usually continued until disease progression in prior clinical trials. The duration of DRd treatment, excluding daratumumab for DRd after treatment response, was associated with OS in a Japanese chart review (19). In a Japanese study, the RDI of daratumumab predicted the OS and time to next treatment in patients with newly diagnosed and relapsed/refractory myeloma treated with DRd (20). Therefore, continuing isatuximab beyond cycle 19 in IsaVRd therapy remains an option for patients aged 80 years or older, considering the immunomodulatory effects of anti-CD38 monoclonal antibodies.

Corticosteroids can induce antimyeloma effects through glucocorticoid receptor-mediated transcriptional regulation, promoting apoptosis via Bim activation and NF-κB suppression (21). They also exert anti-inflammatory effects by mitigating treatment-related toxicities (22). However, long-term corticosteroid use may impair the immune-mediated antimyeloma activity and increase the risk of infection.

The omission of dexamethasone after cycle 3 in the REST trial likely contributed to the low rate of treatment discontinuation owing to adverse events. This approach was supported by the IFM2017-03 trial that demonstrated preserved efficacy and reduced infection rates with dexamethasone-free daratumumab plus lenalidomide therapy in predominantly frail elderly patients (23). Although dexamethasone may retain its value in selected patients with dexamethasone-sensitive relapsed and/or refractory myeloma, as suggested by the TED10893 trial comparing isatuximab plus dexamethasone versus isatuximab alone (24), the REST strategy appears well-suited for older, frail populations. In daily clinical practice, high-dose dexamethasone therapy can achieve short-term disease control in some patients with relapsed and/or refractory myeloma. The results of the TED10893 trial suggest tolerability in patients with dexamethasone-sensitive myeloma clones who experience an additive effect of dexamethasone, particularly given the relatively young age of the patient cohort. The omission of dexamethasone after cycle 3 in the REST trial may have contributed to the reduction in treatment discontinuation due to adverse events. The treatment schedule of the 3- or 4-drug combination, including anti-CD38 monoclonal antibodies, bortezomib, lenalidomide, and dexamethasone, for newly diagnosed myeloma is shown in Table 1.

Table 1

Treatment schedule of 3- or 4-drug combination treatment for newly diagnosed myeloma

Trial CD38 monoclonal antibody Treatment cycle
Isatuximab/daratumumab   Bortezomib   Lenalidomide   Dexamethasone
REST Isatuximab: 10 mg/kg days 1, 8, 15, and 22 on cycle 1; 10 mg/kg days 1 and 15 on cycles 2–18   1.3 mg/m2 days 1, 8, and 15 on cycles 1–8   25 mg days 1–21   20 mg days 1, 8, 15, and 22 on cycles 1–2 4 weeks/cycle
IMROZ Isatuximab: 10 mg/kg days 1, 8, 15, 22, and 29 on cycle 1; 10 mg/kg days 1, 15, and 29 on cycles 2–4; 10 mg/kg days 1 and 15 on cycles 5–17; 10 mg/kg day 1 on cycle 18   1.3 mg/m2 days 1, 4, 8, 11, 22, 25, 29, and 32 on cycles 1–4   25 mg days 1–14 and 22–35 on cycles 1–4; 25 mg on days 1–21 on cycle 5   20 mg days 1, 2, 4, 5, 8, 9, 11, 12, 15, 22, 23, 25, 26, 29, 30, 32, and 33 on cycles 1–4; 20 mg days 1, 8, 15, and 22 on cycle 9 6 weeks/cycle on cycles 1–4; 4 weeks/cycle on cycle 5
BENEFIT Isatuximab: 10 mg/kg days 1, 8, 15, and 22 on cycle 1; 10 mg/kg days 1 and 15 on cycles 2–12; 10 mg/kg day 1 on cycle 19   1.3 mg/m2 days 1, 8, and 15 on cycles 1–12; 1.3 mg/m2 days 1 and 15 on cycles 13–18   25 mg days 1–21 on cycle 1   20 mg days 1, 8, 15, and 22 on cycles 1–12; 20 mg days 1 and 15 on cycles 13–18 4 weeks/cycle
GMMG-HD7 Isatuximab: 10 mg/kg days 1, 8, 15, 22, and 29 on cycle 1; 10 mg/kg days 1, 15, and 29 on cycles 2–3; 10 mg/kg day 1 after ASCT for 3 years   1.3 mg/m2 days 1, 4, 8, 11, 22, 25, 29, and 32 on cycles 1–3   25 mg on days 1–14 and 22–35 on cycles 1–3; 10 mg continuous after ASCT for 3 years   20 mg days 1, 2, 4, 5, 8, 9, 11, 12, 15, 22, 23, 25, 26, 29, and 30 on cycles 1–3; 20 mg days 1, 8, 15, and 22 after ASCT 6 weeks/cycle on cycles 1–3; 4 weeks/cycle after ASCT
CEPHEUS Daratumumab: 1,800 mg/body sc; days 1, 8, and 15/3 weeks on cycles 1–2; day 1 on cycle 3   1.3 mg/m2 days 1, 4, 8, and 11/3 weeks on cycles 1–8   25 mg days 1–14 on cycles 1–8; 25 mg days 1–21 on cycle 9   20 mg days 1, 2, 4, 5, 8, 9, 11, and 12 on cycles 1–8; 40 mg days 1, 8, 15, and 22 on cycle 9 3 weeks/cycle on cycles 1–8; 4 weeks/cycle on cycle 9
PERSEUS Daratumumab: 1,800 mg/body sc; days 1, 8, 15, and 22 on cycles 1–2; days 1 and 15 on cycles 3–6; day 1 on cycle 7   1.3 mg/m2 days 1, 4, 8, and 11 on cycles 1–6   25 mg days 1–21 on cycles 1–6; 10 mg days 1–28 on cycle 7   40 mg days 1–4 and 9–12 on cycles 1–6; 40 mg days 1, 8, 15, and 22 on cycle 7 4 weeks/cycle
MAIA Daratumumab: 16 mg/kg div; days 1, 8, 15, and 22 on cycles 1–2; days 1 and 15 on cycles 3–6; day 1 on cycle 7   NA   25 mg days 1–21   40 mg days 1, 8, 15, and 22 until PD 4 weeks/cycle
IFM2017-04 Daratumumab: 1,800 mg/body sc; days 1, 8, 15, and 22 on cycles 1–2; days 1 and 15 on cycles 3–6; day 1 on cycle 7   NA   25 mg days 1–21   NA 4 weeks/cycle

ASCT, autologous stem cell transplantation; div, drip intravenous; NA, not applicable; PD, progressive disease; sc, subcutaneous injection.

Finally, comparing IsaVRd and DRd among the frail and those over 80 years of age is challenging. IsaVRd was superior to DRd according to an indirect comparison after age matching; elderly patients were excluded (25). In the BENEFIT trial, the time to very good partial response in the IsaVRd group was shorter than in the IsaRd group, suggesting that the addition of bortezomib contributed to earlier responses (16). Therefore, when an early response is required, such as reducing bone pain and improving renal insufficiency, which can be improved by bortezomib, potentially due to activation of osteoblasts and improvement of inflammation in the renal interstitium, IsaVRd might be a good option even in frail patients and those over 80 years of age. The incidences of infection and neutropenia were similar between IsaVRd and IsaRd, although those of peripheral neuropathy and thrombocytopenia were higher in IsaVRd than in IsaRd (16). The incidence of severe neutropenia and infection was similar between patients who received IsaVRd in the REST and BENEFIT trials (7,16). However, the mortality rate not due to progressive disease was high in frail patients, especially within the first 6 months in the IMROZ trial (8), suggesting that close monitoring for infection and adequate supportive care, such as granulocyte colony-stimulating factor (G-CSF) immunoglobulin replacement and prophylaxis with antibiotics, should be considered.

The REST trial demonstrates that quadruplet therapy can be administered safely and effectively to patients aged 80 years or older by modifying the bortezomib and dexamethasone schedules. Although discontinuing bortezomib after cycle 8 and isatuximab after cycle 18 warrants further discussion from an efficacy standpoint, the overall regimen is mechanistically sound and clinically rational. Importantly, the REST treatment schedule may also be applicable to younger patients, including those eligible for transplantation. The accumulation of real-world evidence is essential for refining and validating this approach.

Acknowledgments

None.

Footnote

Provenance and Peer Review: This article was commissioned by the editorial office, Annals of Blood. The article has undergone external peer review.

Peer Review File: Available at https://aob.amegroups.com/article/view/10.21037/aob-2026-1-0002/prf

Funding: None.

Conflicts of Interest: The author has completed the ICMJE uniform disclosure form (available at https://aob.amegroups.com/article/view/10.21037/aob-2026-1-0002/coif). K.S. received personal fees from Janssen Pharmaceutical K.K., Sanofi, Bristol Myers Squibb, GSK, Ono Pharmaceutical Co., Ltd., Pfizer, and Takeda Pharmaceutical Company, outside the submitted work. The author has no other conflicts of interest to declare.

Ethical Statement: The author is accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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doi: 10.21037/aob-2026-1-0002
Cite this article as: Suzuki K. Optimizing quadruplet therapy for older patients with newly diagnosed multiple myeloma: lessons from the REST trial. Ann Blood 2026;11:10.

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