Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, MM, disease registry, Connect®
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.
Interventions
OTHERFirst-line therapy
As prescribed by treating physician
DRUGSecond-line Multiple Myeloma treatments
As prescribed by the treating physician
Sponsors
Celgene
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant baseline demographics | Baseline | — |
| Participant medical history | Baseline | — |
| Participant Multiple Myeloma diagnosis information | Baseline | — |
| Participant Multiple Myeloma treatment history | Baseline | — |
| Multiple Myeloma-related supportive concomitant medications and procedures | Baseline, every 3-months up to 5 years (Cohort 3), or up to 16 years (Cohort 1 & 2), or date of early discontinuation | — |
| Occurance of second primary malignancy | Baseline, every 3-months up to 5 years (Cohort 3), or up to 16 years (Cohort 1 & 2), or date of early discontinuation | — |
| Number of participants enrolled in a clinical trial | Baseline, every 3-months up to 16 years or date of early discontinuation | Cohort 1 and 2 only |
| Lines of therapy prescribed | Baseline, every 3-months up to 5 years (Cohort 3), or up to 16 years (Cohort 1 & 2), or date of early discontinuation | — |
| Participant disease response assessment results | Baseline, every 3-months up to 5 years (Cohort 3), or up to 16 years (Cohort 1 & 2), or date of early discontinuation | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant socioeconomic status | Baseline | Cohort 3 only |
| Participant EuroQol-5 Dimensions (EQ-5D) questionnaire results | Baseline, every 3-months up to 5 years (Cohort 3) or up to 16 years (Cohort 1 and 2), or date of early discontinuation | — |
| Participant Functional Assessment of Cancer Therapy - Multiple Myeloma (FACT-MM) questionnaire results | Baseline, every 3-months up to 5 years (Cohort 3) or up to 16 years (Cohort 1 and 2), or date of early discontinuation | — |
| Participant Visual Analogue Score (VAS) questionnaire results | Baseline, every 3-months up to 5 years (Cohort 3) or up to 16 years (Cohort 1 and 2), or date of early discontinuation | — |
| Participant participant survival status | Every 3-months up to 5 years (Cohort 3) or up to 16 years (Cohort 1 and 2), or date of early discontinuation | — |
| Participant participant Adverse Events (AEs) | Every 3-months up to 5 years (Cohort 3) or up to 16 years (Cohort 1 and 2) or date of early discontinuation | — |
| Reason for registry discontinuation | Date of early discontinuation assessed up to 5 years (Cohort 3) or up to 16 years (Cohort 1 and 2) | — |
| Reason for treatment initiation or discontinuation | Baseline, and every 3-months up to 5 years or date of early discontinuation | Cohort 3 only |
| Participant COVID-19 infection and vaccination status | Baseline, and every 3-months up to 5 years or date of early discontinuation | Cohort 3 only |
| Treating clinician response to frailty questionnaire | Baseline, and every 3-months up to 5 years or date of early discontinuation | Cohort 3 only |
| Participant Brief Pain Inventory (BPI) questionnaire results | Baseline, and every 3-months up to 5 years or date of early discontinuation | Cohort 3 only |
| Participant response to social support questionnaire | Baseline, and every 3-months up to 5 years or date of early discontinuation | Cohort 3 only |
| Treating clinician response to social support questionnaire | Baseline, and every 3-months up to 5 years or date of early discontinuation | Cohort 3 only |
| Number of participants that have received stem cell transplant | Baseline, and every 3-months up to 5 years or date of early discontinuation | Cohort 3 only |
| Number of hospitalization or emergency room visits | Every 3-months up to 5 years (Cohort 3) or up to 16 years (Cohort 1 and 2) or date of early discontinuation | — |
| Cause of death | Every 3-months up to 5 years (Cohort 3) or up to 16 years (Cohort 1 and 2) or date of early discontinuation | — |
Countries
Puerto Rico, United States
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed