Connect® MM- The Multiple Myeloma Disease Registry
Terminated
- Conditions
- Multiple Myeloma
- Interventions
- Other: First-line therapyDrug: Second-line Multiple Myeloma treatments
- Registration Number
- NCT01081028
- Lead Sponsor
- Celgene
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3008
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 1: Patients enrolled between Sep 2009 and Nov 2011 First-line therapy Newly diagnosed multiple myeloma patients enrolled between Sep 2009 and Nov 2011. Cohort 2: Patients enrolled between December 2012 and mid-2016 First-line therapy Newly diagnosed multiple myeloma patients enrolled between Dec 2012 and mid-2016 Cohort 3: Patients enrolled from 2023 Second-line Multiple Myeloma treatments Relapsed/Refractory multiple myeloma patients receiving second-line therapy
- Primary Outcome Measures
Name Time Method Participant medical history Baseline 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 Participant baseline demographics Baseline 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
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 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
- Secondary Outcome Measures
Name Time Method 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
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 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 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 social support questionnaire 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 Participant socioeconomic status Baseline Cohort 3 only
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 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
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
Trial Locations
- Locations (250)
The Cancer Center of Huntsville
🇺🇸Huntsville, Alabama, United States
DCH Health System
🇺🇸Tuscaloosa, Alabama, United States
US Oncology - Arizona Oncology Associates - Rudasill
🇺🇸Tucson, Arizona, United States
St. Edward Mercy Medical Center
🇺🇸Fort Smith, Arkansas, United States
Genesis Cancer Center
🇺🇸Hot Springs, Arkansas, United States
Clopton Clinic Hematology/Oncology
🇺🇸Jonesboro, Arkansas, United States
Little Rock Hematology Oncology Associates, PA
🇺🇸Little Rock, Arkansas, United States
Pacific Cancer Medical Center, Inc
🇺🇸Anaheim, California, United States
Alta Bates Summit Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
Southbay Oncology Hematology Partners
🇺🇸Campbell, California, United States
Scroll for more (240 remaining)The Cancer Center of Huntsville🇺🇸Huntsville, Alabama, United States