Recruiting

Observational Study

Sponsor:

All4Cure

Code:

NCT06149910

Conditions

Multiple Myeloma

Multiple Myeloma Without Mention of Remission

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Multiple Myeloma Pathway

All4Cure Platform

Documentation Pathway

Study Details

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.

Conditions

Multiple Myeloma

Multiple Myeloma Without Mention of Remission

Study ID

NCT06149910

Start date

Apr 18, 2024

Status verified date

May, 2024

Completion date

Dec 1, 2026

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

450 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Multiple Myeloma Pathway

Use and adherence to a multiple myeloma pathway.

All4Cure Platform

Participant in the All4Cure platform.

Documentation Pathway

Use of multiple myeloma pathway through written documentation.

Primary outcome 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. [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Jennifer Wren, BS

(425) 477-9021jenniferw@all4cure.com

Locations

All4Cure

Recruiting

Seattle, Washington, United States, 98126

Contacts

Jennifer Wren

206-501-8354jenniferw@all4cure.com

Cheng Zheng

619-436-7716chengz@all4cure.com

More Information

Sponsor

All4Cure

Last update posted

May 3, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by All4Cure on 2024-05-03.