Evaluating the Uptake and Utility of Clinical Pathways for Newly Diagnosed Patients With Multiple Myeloma

Condition(s) studied

Investigational drug(s) / intervention(s)

Multiple Myeloma Pathway: Use and adherence to a multiple myeloma pathway.

All4Cure Platform: Participant in the All4Cure platform.

Documentation Pathway: Use of multiple myeloma pathway through written documentation.

Study summary

All4Cure is partnering with community oncology practices participating in the Quality Cancer Care Alliance (QCCA) and Exigent Research to develop a clinical pathway that standardizes the evaluation, treatment and ongoing management of patients with newly diagnosed multiple myeloma who wish to achieve and maintain MRD negativity.

This is a longitudinal retrospective study that will collect data from three separate cohorts of patients with newly diagnosed multiple myeloma (NDMM). The cohorts classify patients based on whether care is delivered under an intention to adhere to an MRD-targeted clinical pathway, and if so, whether the implementation of that clinical pathway occurs through participation in the All4Cure platform vs. through written documentation. The three cohorts are labeled: Platform, Documentation, and Off-Pathway.

Eligibility

Primary outcome measure(s)

• To compare rate of tumor response and complete tumor response (≥VGPR and ≥CR) within 12 months of start of front-line therapy between the Documentation and Off-Pathway COHORT groups. — 24 months
  Tumor response will be a binary classification indicating the best tumor response documented through 12 months following start of front-line therapy, based on response assessment of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), stable disease (SD), progressive disease (PD) and not evaluable / not evaluated (NE). Given that the standard of care is to achieve at least a VGPR in the frontline setting, VGPR + sCR + CR will be defined as a tumor response, and other values will be interpreted as nonresponse for the purpose of this objective. Separately, sCR + CR will be interpreted as a complete tumor response, and other values will be interpreted as incomplete (VGPR) or nonresponse (PR, SD or PD). The proportion of patients who achieve VGPR or better any point within 12 months, and separately the proportion of patients who achieve a CR or better, will be compared between the Documentation and Off-Pathway COHORT groups.

Trial sites (1)

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