Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile (CoMMpass)
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|ClinicalTrials.gov Identifier: NCT01454297|
Recruitment Status : Active, not recruiting
First Posted : October 19, 2011
Last Update Posted : August 16, 2018
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||1154 participants|
|Official Title:||A Prospective, Longitudinal, Observational Study in Newly Diagnosed Multiple Myeloma (MM) Patients to Assess the Relationship Between Patient Outcomes, Treatment Regimens and Molecular Profiles|
|Study Start Date :||July 2011|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||September 2023|
Newly diagnosed Multiple Myeloma
This is a prospective observational study in patients with symptomatic multiple myeloma who have not yet initiated therapy for their disease.
- Molecular profiles and clinical characteristics that define subsets of myeloma patients at initial diagnosis and at relapse of disease. [ Time Frame: Baseline to 8 years. ]Standard clinical and laboratory assessments. Genomic tests (DNA and RNA sequencing, etc.) on bone marrow aspirates obtained at baseline, suspected complete response, and relapse/progression.
- Response rates [ Time Frame: Up to one year after baseline. ]IMWG criteria: stringent complete response, complete response, very good partial response, partial response, no response.
- Survival rates [ Time Frame: Five to eight years after baseline ]Progression-free survival and overall survival
- Bone disease assessed radiographically [ Time Frame: Baseline and during five to eight years of follow-up ]
- Health-related quality of life [ Time Frame: Baseline and during five to eight years of follow-up ]EORTC QLQ-C30 and QLQ-MY20
- Resource utilization [ Time Frame: Baseline and during five to eight years of follow-up ]Hospitalizations and ER visits
- Severe adverse events [ Time Frame: Five to eight years ]Severe/CTCAE grade 3-4 adverse events (checklist)
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01454297
|Study Director:||Daniel Auclair||Multiple Myeloma Research Foundation|