An observational study in Multiple Myeloma and Immunoglobulin Light-chain Amyloidosis, sponsored by Takeda. Completed at 14 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-08.
Sponsored by Takeda · Observational
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.
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.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 240 is above the median of 140 across 468 observational studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.
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Participants diagnosed with MM or systemic AL amyloidosis.
Diagnosis of MM and/or AL amyloidosis according to the IMWG for MM and BSH guidelines for AL amyloidosis.
MM diagnostic criteria:
Smouldering MM- Both criteria must be met:
Multiple myeloma- Clonal BM plasma cells >= 10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following myeloma-defining events:
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:
AL amyloidosis diagnosis:
Exclusion Criteria:
Participants diagnosed with MM who have received treatment within 12 months preceding the enrollment will be observed prospectively. Data will be collected from the participants medical charts and via electronic case report forms (eCRFs).
Participants diagnosed with AL Amyloidosis who have received treatment within 12 months preceding the enrollment will be observed prospectively. Data will be collected from the participants medical charts and via eCRFs.
DoT
DoT is defined as the time between the start of a treatment/regimen and the end of that regimen.
Time frame: From start date of treatment reported at study entry until discontinuation of treatment for any reason (approximately 1 year)
PFS
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 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)
Time to Next Treatment (TTNT)
TTNT is defined as time between start of current treatment or regimen and start of next treatment or regimen.
Time frame: From start of current treatment or regimen until start of next treatment or regimen (approximately 1 year)
Number of Participants Categorized Based on Treatment Regimens Prescribed in Routine Clinical Practice
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)
Number of Participants Based on Treatment Response Achieved
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)
Number of Participants Categorized Based on Differences Between Prescribed and Actual DoT, and Reasons for Treatment Discontinuation
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)
Number of Participants Satisfied With the Treatment
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)
Number of Participants Categorized Based on Clinical and Sociodemographic Characteristics Influencing the Treatment Prescribed and Satisfaction With Treatment
Time frame: From start date of treatment reported at study entry until discontinuation of treatment for any reason (approximately 1 year)
Percentage of Participants With More Than one Neoplasm
Time frame: From start date of treatment reported at study entry until discontinuation of treatment for any reason (approximately 1 year)
Percentage of Participants who Achieve the Prescribed DoT According to Treatment Strategy
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.
Time frame: From start date of treatment reported at study entry until discontinuation of treatment for any reason (approximately 1 year)
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Sap, Icf, Csr
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