Multiple MyelomaNCT06149910
Evaluating the Uptake and Utility of Clinical Pathways for Newly Diagnosed Patients With Multiple Myeloma
An observational study of Multiple Myeloma and Multiple Myeloma Without Mention of Remission, run by All4Cure at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Multiple Myeloma Without Mention of Remission
- What is being tested?
- Multiple Myeloma Pathway, All4Cure Platform and Documentation Pathway
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2024to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients seen in a community oncology setting.
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
All4Cure
Seattle, Washington, 98126
Jennifer Wren, 206-501-8354, jenniferw@all4cure.com
Cheng Zheng, 619-436-7716, chengz@all4cure.com
About this study
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
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.
Read the 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.
- Being tested
- Multiple Myeloma Pathway, All4Cure Platform, Documentation Pathway
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple Myeloma PathwayOther
Use and adherence to a multiple myeloma pathway.
All4Cure PlatformOther
Participant in the All4Cure platform.
Documentation PathwayOther
Use of multiple myeloma pathway through written documentation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Multiple Myeloma Pathway; Other: 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. Receives: Other: Multiple Myeloma Pathway; Other: Documentation 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (9)
To compare pathway adherence between the Platform and Documentation COHORT group implementations of the MRD-targeted clinical pathway.
Pathway adherence will be quantified based on the adherence score, which reflects a sum of points credited for pathway-specified activities that are carried out during the 12-month period beginning from the start of treatment. The adherence score will be calculated at 3, 6 and 12-month periods with a minimum possible score of 0 points during all time periods. The maximum possible score will be 30 points during the 3 and 6-month time points and a maximum possible score of 40 points during the 12-month time point. The higher point scores indicate more adherence to the pathway.
Measured: 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).
Measured: 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.
Measured: 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.
This will exclude Off-Pathway patients who received daratumumab as part of their front-line regimen.
Measured: 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.
MRD negativity will be assessed separately based on 10-5 (1/100,000) and 10-6 (1/1,000,000) thresholds, with rates of MRD negativity compared across the Platform and Documentation COHORT groups for each MRD negativity endpoint.
Indication of MRD negativity at any point within 12 months of start of front-line therapy under each of the thresholds will be deemed to constitute MRD-negative status for that threshold endpoint, irrespective of evidence of MRD-positive status at other assessments.
Measured: 12 months
To compare progression-free survival (PFS), time to next treatment (TTNT), and overall survival (OS) between the Documentation and Off-Pathway COHORT groups.
This will be done from a landmark at 6 months after start of front-line therapy, and to compare PFS, TTNT, and OS between the Platform and Documentation COHORT groups from that same landmark time point.
To assess the sensitivity of the results to the selection of landmark timepoint, the analysis will also evaluate outcomes as measured from 3-month and 12-month landmarks.
Measured: 12 months
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.
If more than one obstacle type is reported per patient, each that is documented in the record will be endorsed.
The frequency of patients who encountered each obstacle type, and the frequency of patients who encountered any obstacle (i.e., at least one obstacle), will be reported from among patients whom the record indicates attempted to get treatment with Daratumumab, Revlimid, Velcade, Dexamethasone (D-RVd) or Daratumumab, Revlimid (Dara-R), by COHORT group.
Measured: 24 months
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.
If more than one obstacle type is reported per patient, each that is documented in the record will be endorsed.
The percentage of patients who encountered each obstacle type, and the percentage of patients who encountered any obstacle (i.e., at least one obstacle), will be reported from among patients whom the record indicates attempted to get treatment with Daratumumab, Revlimid, Velcade, Dexamethasone (D-RVd) or Daratumumab, Revlimid (Dara-R), by COHORT group.
Measured: 24 months
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.
This objective requires analysis of the enrolled patient sample as a subset of the underlying eligible population within the QCCA/Exigent network, and will be conducted through analysis of case screening data, without formal data collection from the underlying population of unaccrued eligible patients.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start18 Apr 2024
- Primary completion31 May 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All4Cure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Scientific Affairs, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149910
- Sponsor's protocol ID
- All4Cure03
- Status last verified
- May 2024
- First submitted
- 17 Nov 2023
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06149910
- Acronym / sponsor ID
- All4Cure03
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- All4CureIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Scientific Affairs, LLC
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Platform | – | Other: Multiple Myeloma Pathway, Other: All4Cure PlatformPatients 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 | – | Other: Multiple Myeloma Pathway, Other: Documentation PathwayPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients seen in a community oncology setting.
Key inclusion criteria (11 listed)
- Diagnosis of multiple myeloma
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple Myeloma PathwayUse and adherence to a multiple myeloma pathway. | Other | Documentation, Platform |
| All4Cure PlatformParticipant in the All4Cure platform. | Other | Platform |
| Documentation PathwayUse of multiple myeloma pathway through written documentation. | Other | Documentation |
Primary outcome
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
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.
9 secondary outcomes
To compare pathway adherence between the Platform and Documentation COHORT group implementations of the MRD-targeted clinical pathway.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
To compare progression-free survival (PFS), time to next treatment (TTNT), and overall survival (OS) between the Documentation and Off-Pathway COHORT groups.
Time frame: 12 months
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.
Time frame: 24 months
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.
Time frame: 24 months
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.
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma and Multiple Myeloma Without Mention of Remission, run by All4Cure at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Wren, BS ((425) 477-9021, jenniferw@all4cure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.