Evaluating the Uptake and Utility of Clinical Pathways for Newly Diagnosed Patients With Multiple Myeloma
1 other identifier
observational
450
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2024
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2023
CompletedFirst Posted
Study publicly available on registry
November 29, 2023
CompletedStudy Start
First participant enrolled
April 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
May 3, 2024
May 1, 2024
2.1 years
November 17, 2023
May 2, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Tumor response will be a binary classification indicating the best tumor response documented through 12 months following start of front-line therapy, based on response assessment of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), stable disease (SD), progressive disease (PD) and not evaluable / not evaluated (NE). Given that the standard of care is to achieve at least a VGPR in the frontline setting, VGPR + sCR + CR will be defined as a tumor response, and other values will be interpreted as nonresponse for the purpose of this objective. Separately, sCR + CR will be interpreted as a complete tumor response, and other values will be interpreted as incomplete (VGPR) or nonresponse (PR, SD or PD). The proportion of patients who achieve VGPR or better any point within 12 months, and separately the proportion of patients who achieve a CR or better, will be compared between the Documentation and Off-Pathway COHORT groups.
24 months
Secondary Outcomes (9)
To compare pathway adherence between the Platform and Documentation COHORT group implementations of the MRD-targeted clinical pathway.
24 months
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).
12 months
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.
12 months
: 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.
12 months
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.
12 months
- +4 more secondary outcomes
Other Outcomes (3)
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.
24 months
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.
24 months
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.
24 months
Study Arms (3)
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.
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.
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.
Interventions
Use of multiple myeloma pathway through written documentation.
Eligibility Criteria
Patients seen in a community oncology setting.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- All4Curelead
- Janssen Scientific Affairs, LLCcollaborator
Study Sites (1)
All4Cure
Seattle, Washington, 98126, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2023
First Posted
November 29, 2023
Study Start
April 18, 2024
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
May 3, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share