Smoldering multiple myeloma
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| Section editor | |
|---|---|
 |
Samuel M. Rubinstein, MD University of North Carolina Chapel Hill, NC, USA |
Are you looking for a regimen, but can't find it here? It is possible that we've moved it to the historical regimens page. For placebo or observational studies in this condition, please visit this page. If you still can't find it, please let us know so we can add it!
Note: due to its size/complexity, multiple myeloma has been split into sub-pages:
- Induction (transplant eligible and ineligible)
- First-line consolidation and maintenance
- Relapsed/refractory, including subsequent consolidation and maintenance
- Smoldering multiple myeloma [this page]
| Last updated on 2024-09-06: 4 regimens on this page
7 variants on this page
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Guidelines
Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.
NCCN
- NCCN does not currently have guidelines at this granular level; please see NCCN Guidelines - Multiple Myeloma.
All lines of therapy
Lenalidomide monotherapy
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Lonial et al. 2019 (ECOG E3A06) | 2011-2013 | Phase 3 (E-esc) | Observation | Superior PFS (primary endpoint) PFS36: 91% vs 66% (HR 0.28, 95% CI 0.12-0.62) |
Targeted therapy
- Lenalidomide (Revlimid) 25 mg PO once per day on days 1 to 21
Supportive therapy
- Aspirin 325 mg PO once per day
28-day cycles
References
- ECOG E3A06: Lonial S, Jacobus S, Fonseca R, Weiss M, Kumar S, Orlowski RZ, Kaufman JL, Yacoub AM, Buadi FK, O'Brien T, Matous JV, Anderson DM, Emmons RV, Mahindra A, Wagner LI, Dhodapkar MV, Rajkumar SV. Randomized trial of lenalidomide versus observation in smoldering multiple myeloma. J Clin Oncol. 2020 Apr 10;38(11):1126-1137. Epub 2019 Oct 25. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article PubMed NCT01169337
Lenalidomide & Dexamethasone (Rd)
Rd: Revlimid (Lenalidomide) & low-dose dexamethasone
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Mateos et al. 2013 (QUIREDEX) | 2007-2010 | Phase 3 (E-esc) | Observation | Superior TTP (primary endpoint) Median TTP: NYR vs 21 mo (HR 0.18, 95% CI 0.09-0.32) Superior OS (secondary endpoint) OS36: 94% vs 80% (HR 0.31, 95% CI 0.10-0.91) |
Note: QUIREDEX did not require modern imaging modalities (such as MRI) to rule out active myeloma, and therefore it is probable that many patients on this study had active as opposed to smoldering multiple myeloma.
Targeted therapy
- Lenalidomide (Revlimid) 25 mg PO once per day on days 1 to 21
Glucocorticoid therapy
- Dexamethasone (Decadron) 20 mg PO once per day on days 1 to 4, 12 to 15
Supportive therapy
- Aspirin 100 mg PO once per day
28-day cycle for 9 cycles
Subsequent treatment
- Lenalidomide maintenance
References
- QUIREDEX: Mateos MV, Hernández MT, Giraldo P, de la Rubia J, de Arriba F, López Corral L, Rosiñol L, Paiva B, Palomera L, Bargay J, Oriol A, Prosper F, López J, Olavarría E, Quintana N, García JL, Bladé J, Lahuerta JJ, San Miguel JF. Lenalidomide plus dexamethasone for high-risk smoldering multiple myeloma. N Engl J Med. 2013 Aug 1;369(5):438-47. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT00480363
- DETER-SMM: NCT03937635
- EFC15992: NCT03941860
- ITHACA: NCT04270409
Thalidomide monotherapy
Regimen variant #1, 200 mg/d, indefinite therapy
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Barlogie et al. 2008 (UARK 98-036) | 1998 to not reported | Phase 2 | ||
| Witzig et al. 2012 (MC0289) | 2003-2008 | Phase 3 (E-esc) | Observation | Seems to have superior TTP (primary endpoint) Median TTP: 2.4 vs 1.2 y (HR 0.49, 95% CI 0.26-0.91) |
Note: Zoledronic acid was received in both the control and experimental arms.
Targeted therapy
- Thalidomide (Thalomid) 200 mg PO once per day
Supportive therapy
- Zoledronic acid (Zometa) 4 mg IV once every three months
Continued indefinitely
Regimen variant #2, 200 -> 600 mg/d, indefinite therapy
| Study | Dates of enrollment | Evidence |
|---|---|---|
| Weber et al. 2003 | 1999-2001 | Phase 1/2 |
Note: The median maximal tolerated dose in this study for patients with smoldering myeloma was 400 mg PO once per day
Targeted therapy
- Thalidomide (Thalomid) as follows:
- Cycle 1: 200 mg PO once per day on days 1 to 7, then 300 mg PO once per day on days 8 to 14, then 400 mg PO once per day on days 15 to 21, then 500 mg PO once per day on days 22 to 28
- Cycle 2 onwards: 600 mg PO once per day on days 1 to 28
28-day cycles
Regimen variant #3, 200 -> 800 mg/d, indefinite therapy
| Study | Dates of enrollment | Evidence |
|---|---|---|
| Rajkumar et al. 2001 | Not reported | Phase 2 |
Targeted therapy
- Thalidomide (Thalomid) as follows:
- Cycle 1: 200 mg PO once per day on days 1 to 14, then 400 mg PO once per day on days 15 to 28
- Cycle 2: 600 mg PO once per day on days 1 to 14, then 800 mg PO once per day on days 15 to 28
- Cycle 3 onwards: 800 mg PO once per day on days 1 to 28
28-day cycles
References
- Rajkumar SV, Dispenzieri A, Fonseca R, Lacy MQ, Geyer S, Lust JA, Kyle RA, Greipp PR, Gertz MA, Witzig TE. Thalidomide for previously untreated indolent or smoldering multiple myeloma. Leukemia. 2001 Aug;15(8):1274-6. link to original article dosing details in abstract have been reviewed by our editors PubMed
- Weber D, Rankin K, Gavino M, Delasalle K, Alexanian R. Thalidomide alone or with dexamethasone for previously untreated multiple myeloma. J Clin Oncol. 2003 Jan 1;21(1):16-9. link to original article dosing details in manuscript have been reviewed by our editors PubMed
- UARK 98-036: Barlogie B, van Rhee F, Shaughnessy JD Jr, Epstein J, Yaccoby S, Pineda-Roman M, Hollmig K, Alsayed Y, Hoering A, Szymonifka J, Anaissie E, Petty N, Kumar NS, Srivastava G, Jenkins B, Crowley J, Zeldis JB. Seven-year median time to progression with thalidomide for smoldering myeloma: partial response identifies subset requiring earlier salvage therapy for symptomatic disease. Blood. 2008 Oct 15;112(8):3122-5. Epub 2008 Jul 31. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article PubMed NCT00083382
- MC0289: Witzig TE, Laumann KM, Lacy MQ, Hayman SR, Dispenzieri A, Kumar S, Reeder CB, Roy V, Lust JA, Gertz MA, Greipp PR, Hassoun H, Mandrekar SJ, Rajkumar SV. A phase III randomized trial of thalidomide plus zoledronic acid versus zoledronic acid alone in patients with asymptomatic multiple myeloma. Leukemia. 2013 Jan;27(1):220-5. Epub 2012 Aug 20. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article PubMed NCT00432458
- Update: Abdallah N, Witzig TE, Kumar SK, Lacy MQ, Hayman SR, Dispenzieri A, Roy V, Gertz MA, Bergsagel PL, Rajkumar SV. Phase III randomized trial of Thal+ZLD versus ZLD in patients with asymptomatic multiple myeloma - updated results after 18-year follow-up. Leukemia. 2024 May;38(5):1169-1171. Epub 2024 Feb 28. link to original article PubMed