Smoldering multiple myeloma - null regimens

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The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main SMM page for regimens that include active anticancer treatment.


All lines of therapy

Observation

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Hjorth et al. 1993 1983-1988 Phase 3 (C) MP Did not meet endpoint of OS
Riccardi et al. 2000 (MM87/MM90) 1987-1993 Phase 3 (C) MP Did not meet endpoint of OS
Witzig et al 2012 (MC0289) 2003-2008 Phase 3 (C) Thalidomide Seems to have inferior TTP
Mateos et al. 2013 (QUIREDEX) 2007-2010 Phase 3 (C) Rd Inferior OS
Lonial et al. 2019 (ECOG E3A06) 2011-2013 Phase 3 (C) Lenalidomide Inferior PFS

No treatment.

References

  1. Hjorth M, Hellquist L, Holmberg E, Magnusson B, Rödjer S, Westin J; Myeloma Group of Western Sweden. Initial versus deferred melphalan-prednisone therapy for asymptomatic multiple myeloma stage I--a randomized study. Eur J Haematol. 1993 Feb;50(2):95-102. link to original article contains dosing details in abstract PubMed
  2. MM87/MM90: Riccardi A, Mora O, Tinelli C, Valentini D, Brugnatelli S, Spanedda R, De Paoli A, Barbarano L, Di Stasi M, Giordano M, Delfini C, Nicoletti G, Bergonzi C, Rinaldi E, Piccinini L, Ascari E; Cooperative Group of Study and Treatment of Multiple Myeloma. Long-term survival of stage I multiple myeloma given chemotherapy just after diagnosis or at progression of the disease: a multicentre randomized study. Br J Cancer. 2000 Apr;82(7):1254-60. link to original article contains dosing details in abstract link to PMC article PubMed
  3. 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 contains dosing details in manuscript link to PMC article PubMed NCT00432458
  4. 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 contains dosing details in manuscript PubMed NCT00480363
  5. 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 contains dosing details in manuscript link to PMC article PubMed NCT01169337
  6. AQUILA: NCT03301220
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