Evaluating clinical pathways for newly diagnosed multiple myeloma patients
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
This study is testing different ways to manage treatment for newly diagnosed multiple myeloma patients to see which approach helps them do better and live longer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | All4Cure Industry-sponsored |
| Drugs / interventions | daratumumab |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT06149910 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of clinical pathways in the management of newly diagnosed multiple myeloma patients. It involves three cohorts: one using the All4Cure platform for pathway adherence, another relying on written documentation, and a comparator group not following the pathway. The study will collect retrospective data over a 12-month period to evaluate treatment outcomes, including the achievement of minimal residual disease (MRD) negativity and overall survival. The goal is to standardize care and improve patient outcomes through structured treatment approaches.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been diagnosed with multiple myeloma and are receiving care at participating oncology practices.
Not a fit: Patients who do not have a diagnosis of multiple myeloma or those who are not receiving care at a QCCA/Exigent Research practice may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes and standardized care for patients with newly diagnosed multiple myeloma.
How similar studies have performed: Other studies have shown success with similar clinical pathway approaches, indicating potential for meaningful advancements in treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Seattle, Washington
- All4Cure — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Jennifer Wren, BS
- Email: jenniferw@all4cure.com
- Phone: (425) 477-9021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.