Brief Summary
The purpose of the Connect® MM Registry is to explore the natural history and real world management of patients with newly diagnosed symptomatic multiple myeloma (MM) and provide unique insights into the management of MM and the impact of this hematologic disorder on patients.
Brief Title
Connect® MM- The Multiple Myeloma Disease Registry
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
Cohort 1 and 2
* Newly diagnosed with symptomatic MM within 2 months of enrollment in Connect® MM registry
* Age ≥18 years
* Willing and able to provide signed informed consent
* Agrees to complete patient assessment questionnaires either alone or with minimal assistance from caregivers and/or trained site personnel
Cohort 3
* Received 1L therapy for symptomatic active MM and subsequently has evidence of disease progression. Prior 1L MM treatment received, including anti-myeloma therapy, transplant, chemotherapy, radiation, and surgery, must be known.
* Initiated or intends to initiate 2L systemic therapy for MM after the first documented relapsed/refractory date (i.e. 1L PD).
* Enrollment date must be within 90 days of start date (or intended start date) of 2L systemic therapy.
Exclusion Criteria:
Cohort 1 and 2
- None
Cohort 3
* Patient's 1L MM treatment was for smoldering MM or MGUS, and not for symptomatic MM
* Currently active in any MM Registry, including but not limited to, the Connect® MM registry or another Celgene/BMS-Sponsored registry.
* Patients who have discontinued from Connect® MM or another Celgene/BMS-Sponsored registry could be considered for enrollment in Cohort 3, if inclusion and exclusion criteria are met.
* Currently enrolled or intending to enroll within 90 days in any interventional clinical trial in which any treatment is an investigational product that cannot be identified
Cohort 1 and 2
* Newly diagnosed with symptomatic MM within 2 months of enrollment in Connect® MM registry
* Age ≥18 years
* Willing and able to provide signed informed consent
* Agrees to complete patient assessment questionnaires either alone or with minimal assistance from caregivers and/or trained site personnel
Cohort 3
* Received 1L therapy for symptomatic active MM and subsequently has evidence of disease progression. Prior 1L MM treatment received, including anti-myeloma therapy, transplant, chemotherapy, radiation, and surgery, must be known.
* Initiated or intends to initiate 2L systemic therapy for MM after the first documented relapsed/refractory date (i.e. 1L PD).
* Enrollment date must be within 90 days of start date (or intended start date) of 2L systemic therapy.
Exclusion Criteria:
Cohort 1 and 2
- None
Cohort 3
* Patient's 1L MM treatment was for smoldering MM or MGUS, and not for symptomatic MM
* Currently active in any MM Registry, including but not limited to, the Connect® MM registry or another Celgene/BMS-Sponsored registry.
* Patients who have discontinued from Connect® MM or another Celgene/BMS-Sponsored registry could be considered for enrollment in Cohort 3, if inclusion and exclusion criteria are met.
* Currently enrolled or intending to enroll within 90 days in any interventional clinical trial in which any treatment is an investigational product that cannot be identified
Inclusion Criteria
Inclusion Criteria:
Cohort 1 and 2
* Newly diagnosed with symptomatic MM within 2 months of enrollment in Connect® MM registry
* Age ≥18 years
* Willing and able to provide signed informed consent
* Agrees to complete patient assessment questionnaires either alone or with minimal assistance from caregivers and/or trained site personnel
Cohort 3
* Received 1L therapy for symptomatic active MM and subsequently has evidence of disease progression. Prior 1L MM treatment received, including anti-myeloma therapy, transplant, chemotherapy, radiation, and surgery, must be known.
* Initiated or intends to initiate 2L systemic therapy for MM after the first documented relapsed/refractory date (i.e. 1L PD).
* Enrollment date must be within 90 days of start date (or intended start date) of 2L systemic therapy.
inclusion and
Cohort 1 and 2
* Newly diagnosed with symptomatic MM within 2 months of enrollment in Connect® MM registry
* Age ≥18 years
* Willing and able to provide signed informed consent
* Agrees to complete patient assessment questionnaires either alone or with minimal assistance from caregivers and/or trained site personnel
Cohort 3
* Received 1L therapy for symptomatic active MM and subsequently has evidence of disease progression. Prior 1L MM treatment received, including anti-myeloma therapy, transplant, chemotherapy, radiation, and surgery, must be known.
* Initiated or intends to initiate 2L systemic therapy for MM after the first documented relapsed/refractory date (i.e. 1L PD).
* Enrollment date must be within 90 days of start date (or intended start date) of 2L systemic therapy.
inclusion and
Gender
All
Gender Based
false
Keywords
Multiple Myeloma
MM
disease registry
Connect®
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01081028
Org Class
Industry
Org Full Name
Celgene
Org Study Id
Connect ® MM
Overall Status
Active, not recruiting
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Connect® MM- The Multiple Myeloma Disease Registry
Primary Outcomes
Outcome Measure
Participant baseline demographics
Outcome Time Frame
Baseline
Outcome Measure
Participant medical history
Outcome Time Frame
Baseline
Outcome Measure
Participant Multiple Myeloma diagnosis information
Outcome Time Frame
Baseline
Outcome Measure
Participant Multiple Myeloma treatment history
Outcome Time Frame
Baseline
Outcome Measure
Multiple Myeloma-related supportive concomitant medications and procedures
Outcome Time Frame
Baseline, every 3-months up to 5 years (Cohort 3), or up to 16 years (Cohort 1 & 2), or date of early discontinuation
Outcome Measure
Occurance of second primary malignancy
Outcome Time Frame
Baseline, every 3-months up to 5 years (Cohort 3), or up to 16 years (Cohort 1 & 2), or date of early discontinuation
Outcome Description
Cohort 1 and 2 only
Outcome Measure
Number of participants enrolled in a clinical trial
Outcome Time Frame
Baseline, every 3-months up to 16 years or date of early discontinuation
Outcome Measure
Lines of therapy prescribed
Outcome Time Frame
Baseline, every 3-months up to 5 years (Cohort 3), or up to 16 years (Cohort 1 & 2), or date of early discontinuation
Outcome Measure
Participant disease response assessment results
Outcome Time Frame
Baseline, every 3-months up to 5 years (Cohort 3), or up to 16 years (Cohort 1 & 2), or date of early discontinuation
Secondary Ids
Secondary Id
CC-5013-MM-036
Secondary Id
CA078-1009
Secondary Outcomes
Outcome Description
Cohort 3 only
Outcome Time Frame
Baseline
Outcome Measure
Participant socioeconomic status
Outcome Time Frame
Baseline, every 3-months up to 5 years (Cohort 3) or up to 16 years (Cohort 1 and 2), or date of early discontinuation
Outcome Measure
Participant EuroQol-5 Dimensions (EQ-5D) questionnaire results
Outcome Time Frame
Baseline, every 3-months up to 5 years (Cohort 3) or up to 16 years (Cohort 1 and 2), or date of early discontinuation
Outcome Measure
Participant Functional Assessment of Cancer Therapy - Multiple Myeloma (FACT-MM) questionnaire results
Outcome Time Frame
Baseline, every 3-months up to 5 years (Cohort 3) or up to 16 years (Cohort 1 and 2), or date of early discontinuation
Outcome Measure
Participant Visual Analogue Score (VAS) questionnaire results
Outcome Time Frame
Every 3-months up to 5 years (Cohort 3) or up to 16 years (Cohort 1 and 2), or date of early discontinuation
Outcome Measure
Participant participant survival status
Outcome Time Frame
Every 3-months up to 5 years (Cohort 3) or up to 16 years (Cohort 1 and 2) or date of early discontinuation
Outcome Measure
Participant participant Adverse Events (AEs)
Outcome Time Frame
Date of early discontinuation assessed up to 5 years (Cohort 3) or up to 16 years (Cohort 1 and 2)
Outcome Measure
Reason for registry discontinuation
Outcome Description
Cohort 3 only
Outcome Time Frame
Baseline, and every 3-months up to 5 years or date of early discontinuation
Outcome Measure
Reason for treatment initiation or discontinuation
Outcome Description
Cohort 3 only
Outcome Time Frame
Baseline, and every 3-months up to 5 years or date of early discontinuation
Outcome Measure
Participant COVID-19 infection and vaccination status
Outcome Description
Cohort 3 only
Outcome Time Frame
Baseline, and every 3-months up to 5 years or date of early discontinuation
Outcome Measure
Treating clinician response to frailty questionnaire
Outcome Description
Cohort 3 only
Outcome Time Frame
Baseline, and every 3-months up to 5 years or date of early discontinuation
Outcome Measure
Participant Brief Pain Inventory (BPI) questionnaire results
Outcome Description
Cohort 3 only
Outcome Time Frame
Baseline, and every 3-months up to 5 years or date of early discontinuation
Outcome Measure
Participant response to social support questionnaire
Outcome Description
Cohort 3 only
Outcome Time Frame
Baseline, and every 3-months up to 5 years or date of early discontinuation
Outcome Measure
Treating clinician response to social support questionnaire
Outcome Description
Cohort 3 only
Outcome Time Frame
Baseline, and every 3-months up to 5 years or date of early discontinuation
Outcome Measure
Number of participants that have received stem cell transplant
Outcome Time Frame
Every 3-months up to 5 years (Cohort 3) or up to 16 years (Cohort 1 and 2) or date of early discontinuation
Outcome Measure
Number of hospitalization or emergency room visits
Outcome Time Frame
Every 3-months up to 5 years (Cohort 3) or up to 16 years (Cohort 1 and 2) or date of early discontinuation
Outcome Measure
Cause of death
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Patients with newly diagnosed multiple myeloma and being treated in community or academic settings in the United States
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Daniel Friedman
Investigator Email
dfriedma@montefiore.org
Investigator Phone
dfriedma