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Early Treatment in Smoldering Myeloma Improves Long-Term Outcomes

Use of the treatment combination consisting of Revlimid (lenalidomide) plus dexamethasone during smoldering myeloma appears to significantly improve long-term outcomes for patients. These results were published in The Lancet Oncology, and presented at the 2016 annual meeting of the American Society of Hematology (ASH).

Smoldering myeloma is considered to be a pre-cancerous condition, in which patients do not yet display any symptoms of multiple myeloma, but are at a high risk of progressing to multiple myeloma.

The standard approach for smoldering myeloma was observation, whereby patients were monitored through tests and the presence of symptoms to determine whether their condition had actually progressed to multiple myeloma. If so, patients could then begin treatment.

With the advent of newer agents that result in fewer side effects compared to standard therapy, researchers have begun evaluating the long-term outcomes of patients being treated during their smoldering myeloma phase. Specifically, researchers are exploring whether early treatment can reduce or delay the progression from smoldering myeloma to multiple myeloma; can improve survival outcomes; and/or will results in patients being more resistant to subsequent therapies.

Researchers recently provided long-term outcomes from a phase III clinical trial directly comparing treatment consisting of Revlimid/dexamethasone to no treatment among patients with smoldering myeloma who were at a high risk of developing multiple myeloma (QuickRedex Study).

The trial included 125 patients with smoldering myeloma; one group was treated with Revlimid/dexamethasone and the second group underwent observation. The median follow-up for surviving patients was 75 months.

  • The median time to progression to myeloma had not yet been reached in the group of patients treated with Revlimid/dexamethasone
  • The median time to progression to myeloma was 23 months for patients undergoing observation.
  • Progression to multiple myeloma occurred in 39% of patients treated with Revlimid/dexamethasone, compared with 86% of patients undergoing observation.
  • At 6 years of follow-up, 86% of patients treated with Revlimid/dexamethasone are alive, compared with 62% of patients undergoing observation only.
  • Early treatment with Revlimid/dexamethasone did not appear to create resistance to subsequent treatments

The researchers concluded that because of these positive results, “Positive results from ongoing trials would support the use of early treatment for patients with high-risk disease in the near future.”


Mateos M, Hernandez M, Giraldo P, et al. Sustained Overall Survival Benefit with lenslidomide Plus Dexamethasone Versus No Treatment in Patients with Smoldering Myeloma at High Risk of Progression to Myeloma: Long Term Analysis. Proceedings from the 2016 annual meeting of the American Society of Hematology. Abstract #3308.

Mateos M, Hernandez M, Giraldo P, et al. lenalidomide plus Dexamethasome in Patients with High-Risk Smouldering Multiple Myeloma (QuiRedex): long-term follow-up of a randomized, controlled phase 3 clinical trial.

The Lancet Oncology. DOI: Available at:: Accessed January 31, 2017.

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