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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-18

Study Completion Date

2026-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Multiple Myeloma Multiple Myeloma Without Mention of Remission

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Multiple Myeloma Pathway

Intervention Type OTHER

Use and adherence to a multiple myeloma pathway.

All4Cure Platform

Intervention Type OTHER

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.

Multiple Myeloma Pathway

Intervention Type OTHER

Use and adherence to a multiple myeloma pathway.

Documentation Pathway

Intervention Type OTHER

Use of multiple myeloma pathway through written documentation.

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.

No interventions assigned to this group

Interventions

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Multiple Myeloma Pathway

Use and adherence to a multiple myeloma pathway.

Intervention Type OTHER

All4Cure Platform

Participant in the All4Cure platform.

Intervention Type OTHER

Documentation Pathway

Use of multiple myeloma pathway through written documentation.

Intervention Type OTHER

Eligibility Criteria

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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.

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

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No