If you treat a patient with high-risk smoldering myeloma on trial and they develop biochemical progression by M-spike, but still no CRAB-SLiM criteria, what would you do next?

In this case, the patient had received daratumumab/lenalidomide/dexamethasone as part of a cooperative group trial. Would you say that the patient had had true MM all along in terms of obtaining insurance authorization for autologous transplantation? Would you count this as a line of therapy counting toward CAR-T therapy?

1 Answer

Mednet MemberInvited Expert

Medical Oncology · University of Chicago

Answered on

My personal preference is to not treat smoldering myeloma.

One of the reasons for this is you fall into this very conundrum.

The decision to treat was made while the patient was asymptomatic and without end-organ damage. The patient is now in the exact same scenario, so why should the decision-making be different?

In this case, the trial may have stipulations about when a patient is considered to have progression. In the ECOG study that evaluated len vs. observation in SMM, progression was defined as symptomatic myeloma + biochemical progression (Lonial et al., PMID 31652094). The same is true for the ASCENT trial that is ongoing.

For these reasons, I would not treat and observe for now. If rapid biochemical progression were to occur, that wo...

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