A Study to Investigate the Relationship Between Duration of Treatment and Response in Patients Wi… (NCT04659798) | Clinical Trial Compass
CompletedNot Applicable
A Study to Investigate the Relationship Between Duration of Treatment and Response in Patients With Multiple Myeloma (MM) or Systemic AL Amyloidosis Treated in Real-life Practice
Spain240 participantsStarted 2021-01-22
Plain-language summary
The study will provide information on outcomes in people with multiple myeloma, or systemic AL amyloidosis, or both, under standard care. AL is short for amyloid light-chain. Standard care means the participant will be treated according to their clinic's standard practice. The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.
The aim of the study is to learn if treatment duration makes a difference in how participants with multiple myeloma or systemic AL amyloidosis respond to their treatment.
During the study, participants will be treated according to their clinic's standard practice. Participants must have started their treatment up to 12 months before taking part in this study. During the study, the participants will visit their clinic every 3 months. These are extra visits to their clinic's standard visits.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Diagnosis of MM and/or AL amyloidosis according to the IMWG for MM and BSH guidelines for AL amyloidosis.
✓. Serum M protein (Immunoglobulin G \[IgG\] or IgA greater than or equal to (\>=) 30 gram per liter (g/L) or urinary monoclonal protein (M protein) \>= 500 milligram per 24 hours (mg/24 h) and/or clonal bone marrow (BM) plasma cells (PCs) 1 percent (%) - 60%.
✓. Absence of myeloma-defining events or amyloidosis.
✓. Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically:
✓. Any one or more of the following biomarkers of malignancy:
✓. Under treatment for MM or systemic AL amyloidosis at the time of study entry.
✓. Have started treatment up to 12 months before inclusion for MM or systemic AL amyloidosis, irrespective of the treatment regimen.
✓. Having first, second, third or fourth line of treatment for MM or systemic AL amyloidosis, irrespective of the treatment regimen.
Exclusion criteria
What they're measuring
1
DoT
Timeframe: From start date of treatment reported at study entry until discontinuation of treatment for any reason (approximately 1 year)
2
PFS
Timeframe: From date of the initiation of treatment or regimen the participant is receiving at the time of study entry until progression, death, or 1 year after end of treatment (approximately 1 year)
✕. Participants with planned cessation of treatment for MM or systemic AL amyloidosis from participation to the study (example, due to pregnancy).
✕. Participating in blinded clinical trials, or in clinical trials with no possibility of obtaining information required in this study, or in clinical trials in which participation in other studies is not allowed.