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

All4Cure

Status: Enrolling

Conditions: Multiple Myeloma; Multiple Myeloma Without Mention of Remission

Treatments: Other: Documentation Pathway; Other: All4Cure Platform; Other: Multiple Myeloma Pathway

Study type: Observational

Funder types: Industry

Identifiers

NCT06149910

All4Cure03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

450 participants in 3 patient groups

Platform

Description:

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.

Treatment:

Other: All4Cure Platform

Other: Multiple Myeloma Pathway

Documentation

Description:

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.

Treatment:

Other: Documentation Pathway

Other: Multiple Myeloma Pathway

Off-pathway

Description:

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.