Evaluating the Uptake and Utility of Clinical Pathways for Newly Diagnosed Patients With Multiple Myeloma That Aim to Achieve and Maintain Measurable Residual Disease (MRD)-Negativity in Community Oncology Settings

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
View:

• Diagnosis of multiple myeloma

‣ Diagnosis must occur on or after the formal launch of the MRD-targeted clinical pathway in the Exigent network

⁃ Diagnosis must be indicated by the presence of any of the following diagnostic codes for multiple myeloma: \[C90.00\]

⁃ Diagnosis must be confirmed on human review of the medical record

• Age ≥ 18 years at qualifying diagnosis.

• Patient has continued to receive care at a QCCA/Exigent Research practice for at least 90 days after the index date.

∙ Patients in the Documentation Cohort must meet the following additional inclusion criteria.

∙ • Evidence in the record of a threshold level of adherence to the clinical pathway, or implied intention to adhere to the clinical pathway.

∙ In addition to the inclusion criteria for the documentation cohort, patients in the Platform Cohort must meet the following additional inclusion criteria.

• A record of registration by the patient for participation in the All4Cure platform, including signed HIPAA release forms that allow All4Cure to access their medical records.

• A record of registration by the patient's primary treating physician for participation in the All4Cure platform.

Locations
United States
Washington
All4Cure
RECRUITING
Seattle
Contact Information
Primary
Jennifer Wren, BS
jenniferw@all4cure.com
(425) 477-9021
Time Frame
Start Date: 2024-04-18
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 450
Treatments
Platform
Patients in this cohort are participating in the All4Cure platform and there has been an established intention to treat according to the clinical pathway. Additionally, the patient's primary physician will also be a participant in the All4Cure platform.
Documentation
Patients in this cohort are not participating in the All4Cure platform but there has been an established intention to treat according to the clinical pathway.
Off-pathway
Patients in this cohort are not participating in the All4Cure platform and there has not been in intention to treat according to the clinical pathway that has been established by a landmark time period.
Related Therapeutic Areas
Sponsors
Collaborators: Janssen Scientific Affairs, LLC
Leads: All4Cure

This content was sourced from clinicaltrials.gov

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