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Multiple MyelomaDOrianTNCT04659798

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

An observational study of Multiple Myeloma and Immunoglobulin Light-chain Amyloidosis, run by Takeda at 14 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
240 participants
Where
14 sitesSpain
Study dates
22 Jan 2021to 5 Sep 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants diagnosed with MM or systemic AL amyloidosis.

Who may be able to join

  • 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:
  • 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.
  • 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:
Show all 23Show fewer
  • Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically:
  • Hypercalcemia: serum calcium greater than (>) 0.25 millimole per liter (mmol/L) (> 1 milligram per deciliter [mg/dL]) higher than the upper limit of normal or >2.75 mmol/L (>11 mg/dL).
  • Renal insufficiency: creatinine clearance (CrCl) less than (<) 40 milliliter per minute (mL/min) or serum creatinine >177 micromole/liter (mcmol/L) (>2 mg/dL).
  • Anemia: haemoglobin (Hb) value of >20 g/L below the lower limit of normal or a Hb value of <100 g/L.
  • Bone lesions: one or more osteolytic lesions on skeletal radiography, computed tomography (CT) or positron emission tomography-computed tomography (PET-CT).
  • Any one or more of the following biomarkers of malignancy:
  • >=60% clonal BM plasma cells.
  • Involved/uninvolved serum-free light chain ratio >=100.
  • >1 focal lesions on magnetic resonance imaging (MRI) studies (each focal lesion must be >=5 millimeter (mm) in size).
  • AL amyloidosis diagnosis:
  • In suspected AL amyloidosis, a histological diagnosis is essential and, where possible, a biopsy should be taken from an apparently affected organ. Alternatively, a subcutaneous abdominal fat aspirate and bone marrow biopsy may be examined for amyloid.
  • Congo red staining with classical apple green birefringence under polarized light should be used to test for the presence of amyloid on any histological specimen.
  • The diagnosis of amyloid requires an experienced laboratory as false negative and false positive diagnoses on the basis of histology are not infrequent. Other (non-AL) amyloid fibril types should be excluded by using immunohistochemistry, deoxyribonucleic acid (DNA) analysis, protein sequencing or mass spectrometry.
  • 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.
  • In case of participants with Newly Diagnosed Multiple Myeloma (NDMM) who are candidates to autologous stem cell transplant (ASCT), the ASCT has to be performed before study entry.

Who cannot join

  • 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.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Spain14 sites

  • Hospital Universitario de Burgos

    Burgos, 9006

  • H. Puerta del Mar

    Cadiz, Andalusia, 11009

  • Hospital General Universitario Santa Lucia

    Cartagena, Murcia, 30202

  • H. Universitario de Cabuenes

    Gijón, Principality of Asturias, 33394

  • H. Universitario de Leon

    León, Castille and León, 24071

  • H. Universitario Lucus Agusti

    Lugo, Galicia, 27003

  • H. Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Regional Universitario de Malaga (Carlos de Haya)

    Málaga, Andalusia, 29010

  • H. Universitari Son Espases

    Palma de Mallorca, Balearic Islands, 7120

  • C.H. Salamanca

    Salamanca, Castille and León, 37007

  • C.H.U. Canarias

    San Cristóbal de La Laguna, Canary Islands, 38320

  • H. Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

  • C.H.U. Santiago

    Santiago de Compostela, Galicia, 15706

  • H. Universitario de Araba

    Vitoria-Gasteiz, Basque Country, 1009

Other trials in Spain

About this study

Official title: 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

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.

Read the detailed description

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.

Keywords
Drug Therapy
Medical subject headings
Multiple Myeloma, Immunoglobulin Light-chain Amyloidosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04659798
Study groupRoleWhat they receive
Participants with MMParticipants 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 with AL AmyloidosisParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DoT

    DoT is defined as the time between the start of a treatment/regimen and the end of that regimen.

    Measured: From start date of treatment reported at study entry until discontinuation of treatment for any reason (approximately 1 year)

  2. 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.

    Measured: 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)

Secondary outcomes (8)

  1. Time to Next Treatment (TTNT)

    TTNT is defined as time between start of current treatment or regimen and start of next treatment or regimen.

    Measured: From start of current treatment or regimen until start of next treatment or regimen (approximately 1 year)

  2. 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.

    Measured: From start date of treatment reported at study entry until discontinuation of treatment for any reason (approximately 1 year)

  3. 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.

    Measured: From start date of treatment reported at study entry until discontinuation of treatment for any reason (approximately 1 year)

  4. 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.

    Measured: From start date of treatment reported at study entry until discontinuation of treatment for any reason (approximately 1 year)

  5. 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.

    Measured: From start date of treatment reported at study entry until discontinuation of treatment for any reason (approximately 1 year)

  6. Number of Participants Categorized Based on Clinical and Sociodemographic Characteristics Influencing the Treatment Prescribed and Satisfaction With Treatment

    Measured: From start date of treatment reported at study entry until discontinuation of treatment for any reason (approximately 1 year)

  7. Percentage of Participants With More Than one Neoplasm

    Measured: From start date of treatment reported at study entry until discontinuation of treatment for any reason (approximately 1 year)

  8. 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.

    Measured: From start date of treatment reported at study entry until discontinuation of treatment for any reason (approximately 1 year)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2020
  2. Study start22 Jan 2021
  3. Primary completion24 Apr 2023
  4. Study completion5 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04659798
Sponsor's protocol ID
C16054
Other IDs
U1111-1258-6881
Acronym
DOrianT
Status last verified
Jul 2024
First submitted
2 Dec 2020
Last updated
8 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Myeloma and Immunoglobulin Light-chain Amyloidosis, run by Takeda at 14 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DoT (time frame: From start date of treatment reported at study entry until discontinuation of treatment for any reason (approximately 1 year)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04659798.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.

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