Deeper response predicts better outcomes in high-risk-smoldering-myeloma: results of the I-PRISM phase II clinical trial
Open accessAbstract
Early therapeutic intervention in high-risk smoldering multiple myeloma (HR-SMM) has shown benefits, however, no studies have assessed whether biochemical progression or response depth predicts long-term outcomes. The single-arm I-PRISM phase II trial (NCT02916771) evaluated ixazomib, lenalidomide, and dexamethasone in 55 patients with HR-SMM. The primary endpoint, median progression-free survival (PFS), was not reached (NR) (95% CI: 57.7–NR, median follow-up 50 months). The secondary endpoint, biochemical PFS, was 48.6 months (95% CI: 39.9–NR) and coincided with or preceded SLiM-CRAB in eight patients. For additional secondary objectives, the overall response rate was 93% with 31% achieving complete response (CR) and 45% very good partial response (VGPR) or better. CR correlated strongly with the absence of SLiM-CRAB and biochemical progression. MRD-negativity (10-5 sensitivity) predicted a 5-year biochemical PFS of 100% versus 40% in MRD-positive patients (p = 0.051), demonstrating that deep responses significantly improve time to progression. Exploratory single-cell RNA sequencing linked tumor MHC class I expression to proteasome inhibitor response, and a lower proportion of GZMB+ T cells within clonally expanded CD8+ T cells associated with suboptimal outcomes.
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Some groups have investigated the use of lenalidomide or daratumumab to enhance immune control of high-risk clones.
“As an alternative strategy to eradication, some groups have investigated the use of lenalidomide or daratumumab to enhance immune control of high-risk clones.107,111”
From Evolution of Multiple Myeloma from a Genomic Perspective (2026) · cites this paper as [107]
The Introduction describes the I-PRISM trial of lenalidomide-containing therapy for high-risk smoldering myeloma, and the Results link immune-cell features to treatment response. The paper does not establish that lenalidomide enhanced immune control of high-risk clones; its Discussion instead relates the immune findings to response to proteasome-inhibitor therapy. Daratumumab appears in a cited trial in the References, but was not investigated in I-PRISM. (LLM, conf=0.83)
Experimental — accuracy not yet measuredAll randomized studies (excluding active MM) show a clear advantage in progression-free survival, delaying MM progression, and preventing symptoms/organ damage; a recent study shows an overall survival advantage of early treatment.
“Excluding patients with an active MM according to the most recent guidelines,3 all randomized studies have shown a clear advantage in progression-free survival, in delaying MM progression, in preventing symptoms/organ damage,107-109 and a recent study has also demonstrated the overall survival (OS) advantage of early treatment,111”
From Evolution of Multiple Myeloma from a Genomic Perspective (2026) · cites this paper as [107]
The Introduction (page unavailable) reports improved progression-free survival in two phase III trials and says one study showed improved overall survival. It does not establish that all randomized studies showed these benefits; it also says the overall-survival benefit remains debated and that longer progression-free survival may delay organ damage. The Discussion (page unavailable) reports delayed end-organ damage in previous studies, but not prevention of symptoms or damage across all randomized studies. (LLM, conf=0.86)
Experimental — accuracy not yet measuredSeveral trials have reported the advantages and risks of early intervention in high-risk SMM.
“Several trials have reported the advantages and risks of early intervention in high risk SMM.105-112”
From Evolution of Multiple Myeloma from a Genomic Perspective (2026) · cites this paper as [107]
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- Authors
- Nadeem, O., Aranha, M. P., Redd, R., Timonian, M., Magidson, S., Lightbody, E. D., Alberge, J.-B., Bertamini, L., Dutta, A. K., El-Khoury, H., Bustoros, M., Laubach, J. P., Bianchi, G., O’Donnell, E., Wu, T., Tsuji, J., Anderson, K. C., Getz, G., Trippa, L., Richardson, P. G., Sklavenitis-Pistofidis, R., & Ghobrial, I. M.
- Affiliations
- Harvard University (US)
- Broad Institute (US)
- Dana-Farber Cancer Institute (US)
- NewYork–Presbyterian Hospital (US)
- Brigham and Women's Hospital (US)
- Corresponding author
- Nadeem, Omar
- Ghobrial, Irene M.
- ORCID
- Nadeem, Omar
- Aranha, Michelle P.
- Redd, Robert
- Timonian, Michael
- Magidson, Sophie
- Lightbody, Elizabeth D.
- Alberge, Jean-Baptiste
- Bertamini, Luca
- Dutta, Ankit K.
- Bustoros, Mark
- Laubach, Jacob P.
- Bianchi, Giada
- O’Donnell, Elizabeth
- Tsuji, Junko
- Anderson, Kenneth C.
- Getz, Gad
- Trippa, Lorenzo
- Richardson, Paul G.
- Ghobrial, Irene M.
- Venue
- Nature Communications
- Published
- 2025-01-03
- Volume
- 16
- Issue
- 1
- Pages
- 358-358
- ISSN
- 2041-1723 (ISSN-L)
- PMC
- PMC11698957
- OpenAlex
- W4406037991
- Cited by
- 20
- References
- 45
- Citations by year
- 2026: 10 · 2025: 10
- FWCI
- 14.78
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Nature Communications (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- RePEc: Research Papers in Economics (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- Takeda Pharmaceuticals U.S.A.
- Cancer Research UK
- Dr. Miriam and Sheldon G. Adelson Medical Research Foundation
- U.S. Department of Health & Human Services | NIH | National Cancer Institute (R35CA263817)
- Topics
- Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
- Health Sciences › Medicine › Genetics › Chronic Lymphocytic Leukemia Research
- Health Sciences › Medicine › Oncology › Bone health and treatments
- Keywords
- ixazomib, lenalidomide, dexamethasone, progression-free survival, biochemical progression, minimal residual disease negativity, complete response, MHC class I expression, single-cell RNA sequencing, CD8+ T cells, clonal expansion, early therapeutic intervention
- MeSH terms
- Smoldering Multiple Myeloma, Lenalidomide, Progression-Free Survival, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Boron Compounds, Dexamethasone, Female, Glycine, Humans, Male, Middle Aged, Multiple Myeloma, Treatment Outcome, Disease Progression
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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