Status:
RECRUITING
Evaluating the Uptake and Utility of Clinical Pathways for Newly Diagnosed Patients With Multiple Myeloma
Lead Sponsor:
All4Cure
Collaborating Sponsors:
Janssen Scientific Affairs, LLC
Conditions:
Multiple Myeloma
Multiple Myeloma Without Mention of Remission
Eligibility:
All Genders
18+ years
Brief 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, t...
Detailed 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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 18 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT06149910
Start Date
April 18 2024
End Date
December 1 2026
Last Update
May 3 2024
Active Locations (1)
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1
All4Cure
Seattle, Washington, United States, 98126