Bone Marrow and Kidney Transplant for Patients With Chronic Kidney Disease and Blood Disorders
NCT01758042
AL Amyloidosis, Acute Lymphoblastic Leukemia (ALL)
Boston, Massachusetts, United States
View Trial DetailsNCT Number: NCT04659798
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.
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Notify Me18 year and older
All sexes
Observational
H. Puerta del Mar, Cadiz, Andalusia, Spain
This is a prospective non-interventional study to assess the DoT and response in participants with MM or systemic AL amyloidosis in standard clinical practice.
This study will enroll approximately 250 participants (220 with MM and 30 with systemic AL amyloidosis). Participants will be enrolled in 2 groups:
Participants with MM Participants with AL amyloidosis The study will have a prospective data collection of the participants from clinical records and scheduled visits following the routine clinical practice. All participants will receive treatment at study start and this treatment must have been started within 12 months before the participant's enrollment.
This multi-center study will be conducted in Spain. Participants will be followed until 12 months after enrollment. The overall time to participate in this study is approximately 1 year.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
MM diagnostic criteria:
AL amyloidosis diagnosis:
Exclusion criteria
Time frame: From start date of treatment reported at study entry until discontinuation of treatment for any reason (approximately 1 year)
DoT is defined as the time between the start of a treatment/regimen and the end of that regimen.
Time frame: 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)
PFS: time between start of treatment or regimen and progression or death. PFS for MM will be evaluated according to International Myeloma Working Group(IMWG) and defined per European Society for Medical Oncology(ESMO)guideline. Progressive disease(PD)for MM: increase of 25% from lowest confirmed response value in one of the following criteria: Serum M protein(absolute increase must be>=0.5 g/dL; Serum M protein increases >=1g/dL, if the lowest M component was 5g/dL; Urine M protein(absolute increase must be>=200 mg/24h).PFS for AL amyloidosis will be evaluated as per Guidelines of the British Society for Haematology(BSH).PD for AL amyloidosis: progression from complete response(CR)as any detectable M protein or abnormal free light chain(FLC) ratio(involved light chain must double).Progression from partial response(PR)is defined as a 50% increase in serum M protein to>5.0g/L or 50% increase in urine M protein to>200mg/dL(a visible peak must be present)or FLC increase of 50% to>100mg/L.
Time frame: From start of current treatment or regimen until start of next treatment or regimen (approximately 1 year)
TTNT is defined as time between start of current treatment or regimen and start of next treatment or regimen.
Time frame: From start date of treatment reported at study entry until discontinuation of treatment for any reason (approximately 1 year)
Number of participants will be reported based on treatment regimens prescribed in routine clinical practice including the number of participants based on treatment line (example- first, second, third or fourth line of treatment), the type of regimen (fixed or continuous), the prescribed duration, and the drug combination used. Fixed duration therapy will be defined as regimen prescribed under a fixed number of cycles. Continuous therapy will be defined as a regimen planned to be administered for a prolonged time (example- 2-3 years), without a pre-defined number of cycles, until progression or intolerance of treatment.
Time frame: From start date of treatment reported at study entry until discontinuation of treatment for any reason (approximately 1 year)
Treatment response as: CR,stringent CR(sCR),very good partial response(VGPR),PR, based on IMWG/ESMO guideline for MM; BSH for AL amyloidosis.For MM;CR:negative immunofixation on serum/urine,disappearance of any soft tissue plasmacytomas,<=5%PCs in BM, sCR:CR/normal FLC ratio,absence of clonal PCs by immunochemistry or 2-4 colour flow cytometry;VGPR:serum/urine M protein level <100 mg/24h,PR:reduction in serum M protein by >=50%and in 24h urinary M protein by >=90%or<200 mg/24h,>=50%decrease in difference between involved/uninvolved FLC levels required in place of M protein criteria, serum-free light assay is also unmeasurable,>= 50%reduction in PCs required in place of M protein provided baseline BM PC percentage was >=30%and >=50%reduction in size of soft tissue plasmacytomas if serum/urine M protein are unmeasurable. For AL amyloidosis;CR:normal FLC levels with normal kappa/lambda ratio, negative serum/urine immunofixations,VGPR:reduction in dFLC to <40 mg/l,PR:50%reduction in dFLC.
Time frame: From start date of treatment reported at study entry until discontinuation of treatment for any reason (approximately 1 year)
Participants will be categorized on the basis of difference between prescribed and actual DoT by evaluating treatment duration and reason for treatment discontinuation.
Time frame: From start date of treatment reported at study entry until discontinuation of treatment for any reason (approximately 1 year)
Participant satisfaction regarding treatment will be assessed using Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire V1.4. The TSQM questionnaire, Spanish version, is a generic measure of satisfaction with the prescribed medication consisting of 14 Likert response items of 7 or 5 alternatives, which assess independently: efficacy (3 items), adverse events (AE) (4 items), convenience of treatment (3 items) and overall satisfaction (3 items). Scores range from 0 to 100, with higher score indicates greater satisfaction in that domain.
Time frame: From start date of treatment reported at study entry until discontinuation of treatment for any reason (approximately 1 year)
Time frame: From start date of treatment reported at study entry until discontinuation of treatment for any reason (approximately 1 year)
Time frame: From start date of treatment reported at study entry until discontinuation of treatment for any reason (approximately 1 year)
Treatment strategy as fixed duration therapy or continuous therapy. Fixed duration therapy will be defined as regimen prescribed under a fixed number of cycles. Continuous therapy will be defined as a regimen planned to be administered for a prolonged time (example- 2-3 years), without a pre-defined number of cycles, until progression or intolerance of treatment.
Takeda
Industry
Prospective Non-interventional Study to Investigate the Relationship Between Duration of Treatment (DoT) and Response in Patients With Multiple Myeloma or Systemic AL Amyloidosis Treated in Real-life Clinical Practice
Acronym: DOrianT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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