- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07649525
Personalising Treatment for Myeloma Patients Based on Initial Response to NHS Treatment and Their Overall Fitness Level (iFIT)
iFIT (UK-MRA Myeloma XVIII): Immunotherapy Approaches Adapted for Fitness in Newly Diagnosed Transplant Ineligible Patients With Myeloma
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Emma McNaught
- 전화번호: 0113 343 1978
- 이메일: ctru-ifit@leeds.ac.uk
연구 연락처 백업
- 이름: Catherine Olivier
- 이메일: ctru-ifit@leeds.ac.uk
연구 장소
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Bristol, 영국, BS2 8ED
- Bristol Haematology and Oncology Centre
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연락하다:
- Sally Moore, Dr
- 이메일: ctru-ifit@leeds.ac.uk
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Eastbourne, 영국, BN21 2UD
- Eastbourne District General Hospital
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연락하다:
- John Jones, Dr
- 이메일: ctru-ifit@leeds.ac.uk
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Leeds, 영국, LS9 7TF
- St James University Hospital
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연락하다:
- Frances Seymour, Dr
- 이메일: ctru-ifit@leeds.ac.uk
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London, 영국, SM2 5PT
- The Royal Marsden Hospital
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연락하다:
- Katy Smith, Dr
- 이메일: ctru-ifit@leeds.ac.uk
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Eligibility criteria for registration:
Inclusion criteria for registration:
- Newly diagnosed as having symptomatic MM, plasma cell leukaemia or non-secretory MM according to IMWG diagnostic criteria 2014.
- Considered not suitable to receive autologous stem cell transplant as part of their first line therapy by the treating clinician,
- Planned for treatment with Daratumumab, Lenalidomide and dexamethasone (DRd) as first line therapy as standard of care,
- Aged 18 years or greater,
- Able to provide full informed consent, and
- Prepared to comply with pregnancy prevention plan.
Exclusion criteria for registration:
- Smouldering myeloma (SMM), primary amyloidosis, solitary plasmacytoma of bone or extramedullary plasmacytoma (without additional evidence of myeloma),
- Pregnant, breastfeeding, plans to become pregnant, or plans to father a child whilst enrolled in the study or within 3 months after the last dose,
- Previous treatment for myeloma, except as specified in the protocol,
- Active systemic viral, fungal or bacterial infection requiring systemic therapy. Criteria for specific chronic infections clarified in the protocol, or
- Participation in any other interventional study for myeloma that involves an IMP during treatment and active monitoring.
Additional eligibility criteria for randomisation into iFIT1/iFIT2/iFIT3 pathways, as follows:
Inclusion criteria for randomisation into all iFIT1/iFIT2/iFIT3 pathways:
- Completed 6 cycles of DRd induction therapy after registering within the iFIT study,
- Able to provide full informed consent, and
- Prepared to comply with pregnancy prevention plan.
Inclusion criteria specific to randomisation pathways:
- Dexamethasone may have been stopped due to toxicity and the participant will remain eligible (iFIT1 and iFIT3),
- Planned to continue on at least daratumumab (monthly) and lenalidomide (at any dose level) (iFIT1 and iFIT3),
- Planned to continue on all three DRd medications (dose reductions are allowed) (iFIT2),
- Achieved a partial response (PR) biochemically (irrespective of MRD status) or achieved a ≥VGPR and are MRD positive, as confirmed by HMDS (central laboratory) (iFIT1 and iFIT2),
- Achieved a ≥VGPR and are MRD negative, as confirmed by HMDS (central laboratory) (iFIT3),
- Categorised as FIT or UNFIT according to the IMWG frailty index (iFIT1),
- Categorised as FRAIL according to the IMWG frailty index (iFIT2), and
- Meet the blood criteria specified in the protocol within 14 days before randomisation (haematological and biochemical) (iFIT1).
Exclusion criteria for randomisation into all iFIT1/iFIT2/iFIT3 pathways:
- Received systemic anti-myeloma therapy other than DRd prior to randomisation. Steroids given (by any route) for reasons other than myeloma disease control are allowed,
- Received a stem cell transplant,
- Participation in any other interventional study for myeloma that involves an IMP during treatment and active monitoring, and
- Pregnant, breast feeding, plans to become pregnant, or plans to father a child whilst enrolled in the study or within a specified period after the last dose.
Exclusion criteria specific to randomisation pathways:
- Stable disease (SD) or progressive disease (PD) as per IMWG response criteria (iFIT1 and iFIT2),
- Partial response (PR), stable disease (SD) or progressive disease (PD) as per IMWG response criteria (iFIT3), and
- Further exclusion criteria related to safety of interventions (iFIT1).
Full inclusion and exclusion criteria are listed in the protocol.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: DRd induction
All participants will receive standard of care treatment with daratumumab, lenalidomide, and dexamethasone for an initial 6 cycles.
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Participants will receive daratumumab by subcutaneous injection.
Each cycle is 28 days.
다른 이름들:
Taken orally as capsules.
Each cycle is 28 days.
Dose can be adjusted for frailty and renal function.
다른 이름들:
Taken as oral tablets, oral solution, or given by IV.
Each cycle is 28 days.
Dose can be adjusted for frailty and renal function.
다른 이름들:
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활성 비교기: iFIT1 - DRd to PD
Participants assigned to the iFIT1 pathway and randomised to this arm will continue standard of care treatment with daratumumab, lenalidomide, and dexamethasone until progressive disease.
Dexamethasone may be stopped due to toxicity.
|
Participants will receive daratumumab by subcutaneous injection.
Each cycle is 28 days.
다른 이름들:
Taken orally as capsules.
Each cycle is 28 days.
Dose can be adjusted for frailty and renal function.
다른 이름들:
Taken as oral tablets, oral solution, or given by IV.
Each cycle is 28 days.
Dose can be adjusted for frailty and renal function.
다른 이름들:
|
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실험적: iFIT1 - Daratumumab plus teclistamab (Dara-Tec)
Participants assigned to the iFIT1 pathway and randomised to this arm will receive treatment with daratumumab and teclistamab for a fixed duration and then be actively monitored until progressive disease.
|
Participants will receive daratumumab by subcutaneous injection.
Each cycle is 28 days.
다른 이름들:
Participants will receive teclistamab by subcutaneous injection.
Each cycle is 28 days.
다른 이름들:
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실험적: iFIT1 - Daratumumab plus talquetamab (Dara-Tal)
Participants assigned to the iFIT1 pathway and randomised to this arm will receive treatment with daratumumab and talquetamab for a fixed duration and then be actively monitored until progressive disease.
|
Participants will receive daratumumab by subcutaneous injection.
Each cycle is 28 days.
다른 이름들:
Participants will receive talquetamab by subcutaneous injection.
Each cycle is 28 days.
다른 이름들:
|
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활성 비교기: iFIT2 - DRd to PD
Participants assigned to the iFIT2 pathway and randomised to this arm will continue standard of care treatment with daratumumab, lenalidomide, and dexamethasone until progressive disease.
|
Participants will receive daratumumab by subcutaneous injection.
Each cycle is 28 days.
다른 이름들:
Taken orally as capsules.
Each cycle is 28 days.
Dose can be adjusted for frailty and renal function.
다른 이름들:
Taken as oral tablets, oral solution, or given by IV.
Each cycle is 28 days.
Dose can be adjusted for frailty and renal function.
다른 이름들:
|
|
실험적: iFIT2 - DR to PD
Participants assigned to the iFIT2 pathway and randomised to this arm will continue treatment with daratumumab and lenalidomide until progressive disease.
|
Participants will receive daratumumab by subcutaneous injection.
Each cycle is 28 days.
다른 이름들:
Taken orally as capsules.
Each cycle is 28 days.
Dose can be adjusted for frailty and renal function.
다른 이름들:
|
|
활성 비교기: iFIT3 - DR to PD
Participants assigned to the iFIT3 pathway and randomised to this arm will continue treatment with daratumumab and lenalidomide until progressive disease.
|
Participants will receive daratumumab by subcutaneous injection.
Each cycle is 28 days.
다른 이름들:
Taken orally as capsules.
Each cycle is 28 days.
Dose can be adjusted for frailty and renal function.
다른 이름들:
|
|
실험적: iFIT3 - DR for 18 cycles
Participants assigned to the iFIT3 pathway and randomised to this arm will continue treatment with daratumumab and lenalidomide for 18 cycles, and then be actively monitored until progressive disease.
|
Participants will receive daratumumab by subcutaneous injection.
Each cycle is 28 days.
다른 이름들:
Taken orally as capsules.
Each cycle is 28 days.
Dose can be adjusted for frailty and renal function.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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iFIT1: Progression-free survival (PFS)
기간: From iFIT1 randomisation to PFS event, assessed up to a maximum of 10.5 years post-randomisation.
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The time from iFIT1 randomisation to progression or death from any cause.
Participants alive and progression-free at the time of analysis will be censored at their last known date to be alive and progression-free.
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From iFIT1 randomisation to PFS event, assessed up to a maximum of 10.5 years post-randomisation.
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iFIT2: Event-free survival (EFS)
기간: From iFIT2 randomisation to EFS event, assessed up to a maximum of 6.5 years post-randomisation.
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The time from iFIT2 randomisation to the first of the following events: grade 4 haematological AEs, grade 3 and 4 non-haematological AEs (including SPMs), discontinuation of trial treatment, progression or death.
Participants event-free at the time of analysis will be censored at their last date known to be alive and event-free.
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From iFIT2 randomisation to EFS event, assessed up to a maximum of 6.5 years post-randomisation.
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iFIT3: Progression-free survival (PFS) and participant-reported overall health and quality of life (QoL) - co-primary outcomes
기간: PFS: from iFIT3 randomisation to PFS event, assessed up to a maximum of 10.5 years post-randomisation. QoL: measured at the start of cycle 1 and after 6 28-day cycles of DRd induction, and further timepoints up to 30 months post-iFIT3 randomisation.
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PFS: The time from iFIT3 randomisation to progression or death from any cause. Participants alive and progression-free at the time of analysis will be censored at their last known date to be alive and progression-free. QoL: The GHS/QoL scale score of the EORTC QLQ-C30 questionnaire. The QoL primary endpoint is measured at 30 months (2.5 years) after iFIT3 randomisation. |
PFS: from iFIT3 randomisation to PFS event, assessed up to a maximum of 10.5 years post-randomisation. QoL: measured at the start of cycle 1 and after 6 28-day cycles of DRd induction, and further timepoints up to 30 months post-iFIT3 randomisation.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Progression-free survival (PFS; iFIT2 only)
기간: From iFIT2 randomisation to PFS event, assessed up to a maximum of 10.5 years post-randomisation.
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The time from iFIT2 randomisation to progression or death from any cause.
Participants alive and progression-free at the time of analysis will be censored at their last known date to be alive and progression-free.
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From iFIT2 randomisation to PFS event, assessed up to a maximum of 10.5 years post-randomisation.
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Time to progression (TTP)
기간: From iFIT1/iFIT2/iFIT3 randomisation to TTP event, assessed up to a maximum of 10.5 years post-randomisation.
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The time from iFIT1/iFIT2/iFIT3 randomisation to first documented evidence of disease progression.
Participants who died without progression will be censored at their date of death.
Participants alive and progression-free at the time of analysis will be censored at their last known date to be alive and progression-free.
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From iFIT1/iFIT2/iFIT3 randomisation to TTP event, assessed up to a maximum of 10.5 years post-randomisation.
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Time to second PFS event (PFS2)
기간: From iFIT1/iFIT2/iFIT3 randomisation to PFS2 event, assessed up to a maximum of 10.5 years post-randomisation.
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The time from iFIT1/iFIT2/iFIT3 randomisation to the second documented evidence of progressive disease or death from any cause.
Participants alive and for whom a second progression has not been observed at the time of analysis will be censored at their last known date to be alive and second progression-free.
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From iFIT1/iFIT2/iFIT3 randomisation to PFS2 event, assessed up to a maximum of 10.5 years post-randomisation.
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Overall survival (OS)
기간: From iFIT1/iFIT2/iFIT3 randomisation to OS event, assessed up to a maximum of 10.5 years post-randomisation.
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The time from iFIT1/iFIT2/iFIT3 randomisation to death from any cause.
Participants alive at the time of analysis will be censored at their last known date to be alive.
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From iFIT1/iFIT2/iFIT3 randomisation to OS event, assessed up to a maximum of 10.5 years post-randomisation.
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Event-free survival (EFS; iFIT1 only)
기간: From iFIT1 randomisation to EFS event, assessed up to a maximum of 6.5 years post-randomisation.
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The time from iFIT1 randomisation to the first of the following events: grade 4 haematological AEs (anaemia, neutropenia, thrombocytopenia), grade 3 and 4 non-haematological AEs (including SPMs), discontinuation of trial treatment, progression, or death.
Participants event-free at the time of analysis will be censored at their last date known to be alive and event-free.
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From iFIT1 randomisation to EFS event, assessed up to a maximum of 6.5 years post-randomisation.
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Survival after progression
기간: From disease progression to death, assessed up to a maximum of 10.5 years post-randomisation.
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The time from first documented evidence of disease progression to death from any cause.
Participants alive at the time of analysis will be censored at their last known date to be alive.
This endpoint is only defined for those who experience progression.
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From disease progression to death, assessed up to a maximum of 10.5 years post-randomisation.
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Time to next treatment (TTNT)
기간: From registration to TTNT event, assessed up to a maximum of 10.5 years post-randomisation.
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The time from registration to the date of commencement of next treatment.
Participants who do not receive next line treatment will be censored at the date of the last assessment or follow-up visit where they are known to have received no new therapy.
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From registration to TTNT event, assessed up to a maximum of 10.5 years post-randomisation.
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Overall response rate (ORR)
기간: Measured after 6 28-day cycles of standard of care induction DRd treatment, and further timepoints up to approximately 30 months post-iFIT1/iFIT2/iFIT3 randomisation, dependent on treatment pathway.
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Overall response rate using the disease response category (sCR, CR, VGPR, PR, MR, SD, or PD).
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Measured after 6 28-day cycles of standard of care induction DRd treatment, and further timepoints up to approximately 30 months post-iFIT1/iFIT2/iFIT3 randomisation, dependent on treatment pathway.
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Attainment of ≥VGPR
기간: Measured after 6 28-day cycles of standard of care induction DRd treatment, and further timepoints up to approximately 30 months post-iFIT1/iFIT2/iFIT3 randomisation, dependent on treatment pathway.
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Attainment of ≥VGPR using the binary disease response category (≥VGPR: sCR, CR, VGPR vs. <VGPR: PR, MR, SD, PD).
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Measured after 6 28-day cycles of standard of care induction DRd treatment, and further timepoints up to approximately 30 months post-iFIT1/iFIT2/iFIT3 randomisation, dependent on treatment pathway.
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Attainment of MRD negativity
기간: Measured after 6 28-day cycles of standard of care induction DRd treatment, and further timepoints up to approximately 30 months post-iFIT1/iFIT2/iFIT3 randomisation, dependent on treatment pathway.
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Attainment of MRD negativity using the binary MRD status category (negative vs. positive) measured using flow cytometry.
MRD negativity is defined as at least a serological VGPR and MRD negative bone marrow aspirate at the 10^-5 threshold.
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Measured after 6 28-day cycles of standard of care induction DRd treatment, and further timepoints up to approximately 30 months post-iFIT1/iFIT2/iFIT3 randomisation, dependent on treatment pathway.
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Maximum response
기간: From iFIT1/iFIT2/iFIT3 randomisation up to a maximum of 6.5 years post-randomisation.
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The maximum response attained.
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From iFIT1/iFIT2/iFIT3 randomisation up to a maximum of 6.5 years post-randomisation.
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Time to improved response
기간: From iFIT1/iFIT2/iFIT3 randomisation to first recorded improved response, up to a maximum of 6.5 years post-randomisation.
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The time from iFIT1/iFIT2/iFIT3 randomisation to first recorded improved response, where the baseline response is that recorded at the start of randomised treatment (iFIT1/iFIT2/iFIT3 cycle 1, day 1).
Participants whose disease progresses or who die before an improved response is recorded will be censored at the time of progression or death, respectively.
Participants alive with no improved response recorded at the time of analysis will be censored at their last known date to be alive.
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From iFIT1/iFIT2/iFIT3 randomisation to first recorded improved response, up to a maximum of 6.5 years post-randomisation.
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Treatment compliance
기간: From registration to the end of trial treatment, up to a maximum of 7 years post-registration.
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Treatment compliance including whether all cycles of treatment were completed, the number of cycles completed, the total dose of each trial medication received, the number and causes of dose omissions, dose delays, and dose reductions.
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From registration to the end of trial treatment, up to a maximum of 7 years post-registration.
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Toxicity and safety as graded by NCI-CTCAE v5
기간: From registration up to a maximum of 11 years post-registration. SAEs may be reported up to 60 days post-last dose of protocol treatment/cycle of active monitoring.
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Toxicity and safety based on the adverse events reported as graded by NCI-CTCAE v5.
Pregnancies will also be reported.
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From registration up to a maximum of 11 years post-registration. SAEs may be reported up to 60 days post-last dose of protocol treatment/cycle of active monitoring.
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Incidence of secondary primary malignancies
기간: Measured during standard of care induction DRd treatment and following iFIT1/ iFIT2/iFIT3 randomisation, up to a maximum of 11 years post-registration.
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The number and details of all other cancers, defined as secondary primary malignancies.
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Measured during standard of care induction DRd treatment and following iFIT1/ iFIT2/iFIT3 randomisation, up to a maximum of 11 years post-registration.
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Incidence, rate, and type of infections as graded by NCI-CTCAE v5
기간: Measured during standard of care induction DRd treatment and following iFIT1/iFIT2/iFIT3 randomisation, up to a maximum of 7 years post-registration.
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Measured using the proportion of participants experiencing an infection of any type or grade as graded by NCI-CTCAE v5.
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Measured during standard of care induction DRd treatment and following iFIT1/iFIT2/iFIT3 randomisation, up to a maximum of 7 years post-registration.
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Quality of life using questionnaires
기간: Measured at the start of cycle 1 and after 6 28-day cycles of DRd induction, and timepoints up to 30 months post-randomisation. The IL414 is measured at the induction timepoints and in iFIT1, and the STTA after 6 28-day cycles of induction and in iFIT1.
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Measured using the EQ-5D-5L, EORTC QLQ-C30, EORTC QLQ-IL413 questionnaires.
This will also be measured using the EORTC QLQ IL414 questionnaire and the Scale of Subjective Total Taste Acuity (STTA) at specified timepoints only.
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Measured at the start of cycle 1 and after 6 28-day cycles of DRd induction, and timepoints up to 30 months post-randomisation. The IL414 is measured at the induction timepoints and in iFIT1, and the STTA after 6 28-day cycles of induction and in iFIT1.
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Objective measures of function
기간: Measured at the start of cycle 1, after 3 28-day cycles, and after 6 28-day cycles of standard of care induction DRd.
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Measured using the 4 metre walk test and mini-cog assessments.
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Measured at the start of cycle 1, after 3 28-day cycles, and after 6 28-day cycles of standard of care induction DRd.
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Cost-utility
기간: Measured at the start of cycle 1 of DRd induction, after 6 28-day cycles of DRd induction, and further timepoints up to 30 months post-iFIT1/iFIT2/iFIT3 randomisation.
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Measured using costs, QALYs and net health benefit (QALYs below £20,000).
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Measured at the start of cycle 1 of DRd induction, after 6 28-day cycles of DRd induction, and further timepoints up to 30 months post-iFIT1/iFIT2/iFIT3 randomisation.
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Exploratory endpoint - investigation into bone disease and therapy
기간: From registration up to a maximum of 7 years post-registration.
|
Observe and understand current UK bone therapy practice and investigate how it impacts on various bone and clinical myeloma outcomes, in order to generate hypotheses to inform future research in this area.
This includes bone therapy planned and prescribed, dental assessment received, and bone disease (including SREs) experienced.
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From registration up to a maximum of 7 years post-registration.
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Exploratory endpoint - infection interactions and infection risk (iFIT1 only)
기간: From iFIT1 randomisation up to a maximum of 6.5 years post-randomisation.
|
Certain genetic characteristics and medical history are suspected to influence the incidence and rate of infections.
These will be investigated under this endpoint including iVIG usage and vaccination history.
The ability to predict prospectively which participants are most at risk of infections could support the implementation of novel immunotherapies in practice.
This will also be investigated under this endpoint.
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From iFIT1 randomisation up to a maximum of 6.5 years post-randomisation.
|
공동 작업자 및 조사자
수사관
- 연구 의자: Gordon Cook, Leeds Institute of Clinical Trials Research
- 연구 의자: Charlotte Pawlyn, Institute of Cancer Research, United Kingdom
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 혈관 질환
- 심혈관 질환
- 병리학적 과정
- 신생물
- 면역계 질환
- 조직학적 유형에 따른 신생물
- 혈액 질환
- 림프 증식 장애
- 면역증식성 장애
- 지혈 장애
- 파라단백혈증
- 혈액 단백질 장애
- 출혈성 장애
- 백혈병
- 병리학적 상태, 징후 및 증상
- 헴 및 림프병
- 여림
- 다발성 골수종
- 신생물, 형질세포
- 백혈병, 형질세포
- 아미노산, 펩티드 및 단백질
- 단백질
- 유기 화학 물질
- 이종 사이 클릭 화합물, 1- 링
- 이종 사이 클릭 화합물
- 이종 사이 클릭 화합물, 2- 링
- 이종 사이 클릭 화합물, 융합 링
- 카르 복실 산
- 다 환식 화합물
- 효소
- 효소 및 코엔자임
- 파이퍼 리딘
- Pretadienes
- 임신
- 스테로이드
- 융합 링 화합물
- 스테로이드, 불소
- Pregnadienetriols
- 프탈리 미드
- 프탈산
- 산, 카르 보 사이 클릭
- 파이퍼리돈
- Isoindoles
- 트랜스퍼 라 제
- 단백질 키나제
- 포스 포 트랜스퍼 라제 (알코올 그룹 수용체)
- 포스 포 트랜스퍼 라제
- 세포 내 신호 전달 펩티드 및 단백질
- 단백질-티로신 키나제
- 레날리도마이드
- 덱사메타손
- 다라 토무 맙
- 탈케타 맙
- FUMIGANT 93
- 달린 단백질, 디티오스텔리움
- 초점 접착 단백질 티로신 키나제
기타 연구 ID 번호
- 1010810
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
De-identified individual participant data datasets generated and/or analysed during the current study will be available upon request from the Clinical Trials Research Unit, University of Leeds (contact CTRU-DataAccess@leeds.ac.uk in the first instance).
The conditions of release for aggregate data may differ from those applying to individual participant data. Requests for aggregate data should also be sent to the above email address to discuss and agree suitable requirements for release.
IPD 공유 기간
IPD 공유 액세스 기준
Data will be released for legitimate secondary research purposes, where the Chief Investigators, Sponsor and CTRU agree that the proposed use has scientific value and will be carried out to a high standard (scientific rigour and information governance and security), and that suitable resources are available. Data will be released in line with participants' consent, all applicable laws relating to data protection and confidentiality, and any contractual obligations to which the CTRU is subject. No IPD will be released before an appropriate agreement is in place governing data retention, usually stipulating that data recipients must delete their copy of the data at the end of the project.
The CTRU believes it is best practice for researchers who generated datasets to be involved in subsequent uses of those datasets. Recipients of trial data for secondary research will also receive data dictionaries, key trial documents and any other information required to reuse the datasets.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
다발성 골수종(MM)에 대한 임상 시험
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Sanko University완전한MULTİPLE SCLEROSİS | BALANCE | 유효성 | 신뢰도터키 (Türkiye)
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University Hospital, Montpellier종료됨제1형 당뇨병 | Basal-bolus multiple-dily 인슐린 주사 | 인슐린 펌프(CSII)프랑스
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Institute of Hematology & Blood Diseases Hospital...Hebei Taihe Chunyu Biotechnology Co., Ltd모병형질 세포 백혈병 | 18-70 세의 초 고위험 MM (UHR-MM), ASCT에 적합합니다. 다음 UHR-MM 정의를 충족하십시오 | 세포 유전학 매우 높은 위험 | 1 차 내화 | 초기 진행 | 비 초간성 외부 수중 침투 | R2-ISS-IV /MPSS-IV중국
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National Taiwan University Hospital모병
-
AbbVie모집하지 않고 적극적으로월경 편두통 (MM)중국, 체코, 독일, 헝가리, 이탈리아, 일본, 폴란드, 포르투갈, 대한민국, 스페인, 대만, 영국
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Miracle Wellness LLC아직 모집하지 않음편두통 | 편두통 | 생리 편두통 | 월경 편두통(MM) 두통 | 편두통 장애 | 성인의 편두통 | 편두통 질환 | 편두통 장애미국
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Cancer Institute and Hospital, Chinese Academy...Byterna Therapeutics Ltd.아직 모집하지 않음
-
Peking Union Medical College Hospital아직 모집하지 않음
-
Sinocelltech Ltd.모병
Daratumumab에 대한 임상 시험
-
Institute of Hematology & Blood Diseases Hospital...모병
-
Celltrion모병
-
Memorial Sloan Kettering Cancer CenterTrillium Therapeutics Inc.모집하지 않고 적극적으로
-
University Hospital, Martin모병
-
Hospices Civils de LyonJanssen-Cilag Ltd.; INSERM U1111아직 모집하지 않음면역 요법 | 독성 표피 괴사 | 피부 부작용 약물 반응 (CADR)프랑스
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Takeda종료됨재발성 및/또는 불응성 다발성 골수종(RRMM)미국, 캐나다
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City of Hope Medical CenterNational Cancer Institute (NCI)모병
-
Assistance Publique - Hôpitaux de ParisJanssen, LP완전한
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Suzanne Lentzsch, MDJanssen Pharmaceuticals모병