Clinical trial NCT06149910: Evaluating the Uptake and Utility of Clinical Pathways for Newly Diagnosed Patients With Multiple Myeloma
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Multiple Myeloma Without Mention of Remission
Lead sponsor: All4Cure
Sponsor class: INDUSTRY
Collaborators: name: Janssen Scientific Affairs, LLC
First posted: 2023-11-29
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients seen in a community oncology setting.

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, 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.

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 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 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.

Primary outcomes:
measure: To compare rate of tumor response and complete tumor response (≥VGPR and ≥CR) within 12 months of start of front-line therapy between the Documentation and Off-Pathway COHORT groups.
timeFrame: 24 months
Secondary outcomes:
measure: To compare pathway adherence between the Platform and Documentation COHORT group implementations of the MRD-targeted clinical pathway.
timeFrame: 24 months
measure: To compare rate of tumor response and complete tumor response (≥VGPR and ≥CR) within 12 months of start of front-line therapy between PATHWAY groups (On-Pathway vs. Off-Pathway).
timeFrame: 12 months
measure: To compare rate of tumor response and complete tumor response (≥VGPR and ≥CR) within 12 months of start of front-line therapy between the Platform and Off-Pathway COHORT groups.
timeFrame: 12 months
measure: : To compare rate of tumor response and complete tumor response (≥VGPR and ≥CR) within 12 months of start of front-line therapy between the Documentation and Off-Pathway COHORT groups.
timeFrame: 12 months
measure: To assess rates of MRD negativity (at 10-5 and 10-6 thresholds) at any point through 12 months after start of front-line therapy between the Platform and Documentation COHORT group implementations of the MRD-targeted clinical pathway.
timeFrame: 12 months
measure: To compare progression-free survival (PFS), time to next treatment (TTNT), and overall survival (OS) between the Documentation and Off-Pathway COHORT groups.
timeFrame: 12 months
measure: To describe the frequency of patients that encountered obstacles reported in the record to accessing D-RVd for induction therapy or for accessing Dara-R for maintenance therapy from third-party payers.
timeFrame: 24 months
measure: To describe the percentage of patients that encountered obstacles reported in the record to accessing D-RVd for induction therapy or for accessing Daratumumab, Revlimid (Dara-R) for maintenance therapy from third-party payers.
timeFrame: 24 months
measure: To estimate the percentage of all patients with NDMM to whom care was provided within the QCCA/Exigent network from the date of the first patient enrolled to the date of the last patient enrolled.
timeFrame: 24 months
Other outcomes:
measure: To examine the rate of tumor response and complete tumor response (≥VGPR and ≥CR) within 12 months of the start of front-line therapy as a function of pathway adherence, controlling demographic and clinical characteristics.
timeFrame: 24 months
measure: To describe the rates of sustained MRD negativity (at 10-5 and 10-6 thresholds) observed during the study period across the Platform and Documentation COHORT group implementations of the MRD-targeted clinical pathway.
timeFrame: 24 months
measure: This exploratory objective will consider whether it is of interest to explore further analysis under those objectives with the subset of patients who are transplant eligible.
timeFrame: 24 months
Locations:
city: Seattle
country: United States
facility: All4Cure
state: Washington
Study officials:
References: