in 61% of participants 
and 37% demonstrated 
complete response, DOR 
was not reached, PFS was 
17.2 months and median 
overall survival (OS) was 
24.6 months. Among the 
evaluable 
participants 
with complete response 
or better, 90.3% had nega-
tive MRD. 7, 8
The 
FDA 
granted 
accelerated 
approval 
to talquetamab in the 
fourth 
or 
later 
line 
based on the phase I/II 
MonumenTAL-1 
trial. 
The 0.4 mg/kg once a 
week group had an ORR 
was 74.1% and CR was 
32.9%, while the 0.8 mg/
kg every two weeks group 
had an ORR of 69.5% and 
CR of 40.3%. At median follow-up of 38.2 months, the 
weekly group had a DOR of 9.5 months and the biweekly 
group DOR was 17.5 months. PFS was 7.5 months and 
11.2 months and OS was 34 months and 28.3 months, 
for the weekly and biweekly groups, respectively. MRD 
negativity was 64.3% and 65.2%.9
In July 2025, another BiTE, linvoseltamab, became 
an option for MM patients in the fourth or later line 
with 
even 
better 
outcomes. 
Linvoseltamab-gcpt 
gained FDA approval based on data from the phase 1/2 
LINKER-MM1 trial which showed that at a median 
follow-up of 21.3 months, 71% of participants achieved 
ORR and 52% of patients demonstrated complete 
response or better. MRD negativity was achieved in 94% 
of evaluable patients with complete response. DOR was 
29.4 months, PFS was not reached, and OS was 31.4 
months. ORR exceeded 50% in all subgroups assessed.10
Given these new therapeutic options, there is every 
reason for hope for extending survival even in veterans 
receiving fourth and later lines of therapy. 
1 Huber JH, Wang M, Wang R, Schoen MW, Colditz GA, Wang 
SY, Chang SH. Overestimation of multiple myeloma survival from 
cancer registry data. J Natl Cancer Inst. 2026 Feb 6:djag028. doi: 
10.1093/jnci/djag028. Epub ahead of print. PMID: 41652897; PMCID: 
PMC12967285.
2 Kastritis E, Solia I, Malandrakis P, Theodorakakou F, Ntanasis-
Stathopoulos I, et al. Patterns of progression among 427 patients with 
smoldering myeloma diagnosed after 2014: importance of monitoring. 
Blood Adv. 2025 Sep 9;9(17):4444-4447. doi: 10.1182/bloodadvanc-
es.2025016083. PMID: 40163763; PMCID: PMC12410520.
3 Akhlaghi T, Maclachlan KH, Wiggins A, Usmani SZ, Derkach A,  
Hultcrantz M. Prognosis and patterns of progression in smolder-
ing multiple myeloma. Blood Adv. 2026 Feb 24;10(4):1344-1347. 
doi: 10.1182/bloodadvances.2025018021. PMID: 41380108; PMCID: 
PMC12927049.
4 Kumar SK, Callander NS, Adekola K, et al. Multiple Myeloma, Ver-
sion 5.2026, NCCN Clinical Practice Guidelines In Oncology. J Natl 
Compr Canc Netw. 2026;24(1):e260001. doi:10.6004/jnccn.2026.0001. 
5 Kaur G, Sannareddy A, Perkins A, et al. Demographic Character-
istics and Treatment Patterns in Veterans with Multiple Myeloma: 
A Comprehensive Analysis from the Veterans Affairs Database 
(2000-2020). Blood. 142(S1):7370. November 2, 2023. doi.org/10.1182/
blood-2023-189965.
6 Moreau P, Garfall AL, van de Donk NWCJ, Nahi H, San-Miguel JF, et 
al. Teclistamab in Relapsed or Refractory Multiple Myeloma. N Engl J 
Med. 2022 Aug 11;387(6):495-505. doi: 10.1056/NEJMoa2203478. Epub 
2022 Jun 5. PMID: 35661166; PMCID: PMC10587778.
7 Lesokhin AM, Tomasson MH, Arnulf B, Bahlis NJ, Miles Prince H, 
et al. Elranatamab in relapsed or refractory multiple myeloma: phase 
2 MagnetisMM-3 trial results. Nat Med. 2023 Sep;29(9):2259-2267. 
doi: 10.1038/s41591-023-02528-9. Epub 2023 Aug 15. PMID: 37582952; 
PMCID: PMC10504075.
8 Prince HM, Bahlis NJ, Rodriguez-Otero P, Karlin L, Akard L., et al. 
MagnetisMM-3: Long-Term Update and Efficacy and Safety of Less 
Frequent Dosing of Elranatamab in Patients with Relapsed or Refrac-
tory Multiple Myeloma. Poster. 2025 FLASCO Spring Congress, April 
4-5, 2025, Orlando, FL.
9 Chari A, Touzeau C, Schinke C, Minnema MC, Berdeja JG, et al. 
Safety and activity of talquetamab in patients with relapsed or refrac-
tory multiple myeloma (MonumenTAL-1): a multicentre, open-label, 
phase 1-2 study. Lancet Haematol. 2025 Apr;12(4):e269-e281. doi: 
10.1016/S2352-3026(24)00385-5. Epub 2025 Mar 13. PMID: 40090350.
10 Lee HC, Zonder JA, Dhodapkar MV, Jagannath S, Hoffman JE, et al. 
Linvoseltamab in Patients With Relapsed/Refractory Multiple My-
eloma in the LINKER-MM1 Study: Longer Follow-Up and Subgroup 
Analyses. Clin Lymphoma Myeloma Leuk. 2026
Source: International Myeloma Working Group risk stratification model for smoldering multiple myeloma (SMM) Blood 
Cancer J. 2020;10(10):102. doi: 10.1038/541408-020-00366-3.
	
	
2 0 2 6  C O M P E N D I U M  O F  F E D E R A L  M E D I C I N E  
3 1
International Myeloma Working Group risk stratification model  
for smoldering multiple myeloma

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