Overview
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.
Description
The study will employ two implementations of an MRD-targeted pathway one that disseminates pathway guidance through written documentation, and another that leverages the All4Cure platform to support pathway adherence through direct engagement of other experts, and through integration of elements of the MRD-targeted pathway into the structured components of the platform. The study also includes a comparator cohort of patients not being treated according to the clinical pathway. Analysis under the primary objective will evaluate outcomes between patients being treated following written pathway documentation and patients being treated off pathway. The primary endpoints are the proportion of patients with achievement of VGPR or better (≥VGPR), and the proportion of patients with a CR or better (≥CR), within 12 months. Secondary endpoints include MRD negativity, pathway adherence, time to next treatment (TTNT), progression-free survival (PFS), overall survival (OS), and obstacles to getting daratumumab treatment. Sustained MRD negativity is an exploratory endpoint.
Data will be collected retrospectively, through stratified random sampling by race within cohort, with patients accrued over a 12-month period. All patients will be followed over time after accrual, with minimum available follow-up of 12 months. Accordingly, the estimated period from first accrual to last follow-up will be approximately 24 months.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients with a concurrent other malignancy (except basal cell carcinoma, squamous
cell carcinoma of the skin, or in situ malignancies of breast or cervix), or those who
have received treatment of another malignancy within three years prior to diagnosis of
multiple myeloma (except for treatment of basal cell carcinoma, squamous cell
carcinoma of the skin, or in situ malignancies of breast or cervix), are excluded from
eligibility.
- Patients with multiple myeloma subtypes Immunoglobulin D (IgD) or Immunoglobulin E
(IgE) are excluded due to the very low rate of these subtypes.
- Patients who transfer their care to another facility outside the QCCA/Exigent Research
network within the first 90 days after NDMM diagnosis are excluded.