NCT03433001 · REGISTRY CONDITION SEARCH

A Study in Relapsed and/or Refractory Multiple Myeloma Patients Treated With Ixazomib Plus Lenalidomide and Dexamethasone

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: Not reported
Status at capture: COMPLETED
Registry last update: 2023-12-07

The purpose of this study is to investigate the real world effectiveness and safety of ixazomib in combination with lenalidomide and dexamethasone (IRd) in patients with relapsed and/or refractory multiple myeloma (RRMM), under conditions of standard medical care. In addition, an exploratory study of biomarkers will be conducted.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression-Free Survival (PFS)

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outcome · POSTED

PFS Rate at 12 Months and 24 Months After the Start of Treatment

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Percentage of Participants Who Achieve or Maintain Any Best Response

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outcome · POSTED

Time to Next Treatment (TTNT)

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outcome · POSTED

Duration of Therapy (DOT)

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outcome · POSTED

Percentage of Participants Who Continue to Receive Treatment at 12 Months and 24 Months After Start of Treatment

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outcome · POSTED

Overall Response Rate (ORR)

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outcome · POSTED

Percentage of Participants Who Achieve VGPR or Better (CR+VGPR)

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outcome · POSTED

Patient-Reported Outcome Health-Related Quality of Life (HRQoL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Global Health Status Score

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outcome · POSTED

Patient-Reported Outcome HRQoL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Score

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outcome · POSTED

Rate of Minimal Residual Disease (MRD) Negativity in Bone Marrow in Participants Who Achieved CR

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outcome · POSTED

Relative Dose Intensity (RDI)

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outcome · POSTED

Percentage of Participants With Bone Lesions (Bone Evaluation)

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outcome · POSTED

Number of Participants Reporting One or More Treatment-Emergent AEs (TEAEs)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: 1. Men and women aged 20 years or older at the time of enrollment 2. Patients with RRMM 3. Participants who are scheduled to start IRd therapy 4. Participants who can provide written informed consent of their own free will before the start of study treatment 5. Participants who are judged by the principal investigator or investigator(s) to have the faculty to understand and comply with the requirements of the study Exclusion Criteria: 1. Female Participants who are nursing or pregnant 2. Participants who have been treated with ixazomib 3. Participants with hypersensitivity to any of the components of IRd therapy, their analogs or excipients 4. Participants with another active malignancy, i.e. synchronous active malignancy or previous malignancy with a disease-free period of less than 5 years, except for participants with carcinoma in situ (intraepithelial carcinoma) or intramucosal carcinoma judged to be cured by topical treatment 5. Participants who are not registered with, or comply with, the guidelines of the lenalidomide management program 6. Participants who, in the judgement of the principal investigator or investigator(s), are considered to be unsuitable for enrolment into the study
healthy Volunteers: false
minimum Age: 20 Years
sampling Method: NON_PROBABILITY_SAMPLE
sex: ALL
std Ages: ADULT
OLDER_ADULT
study Population: The study population will consist of adult men and women who have a confirmed diagnosis of multiple myeloma, who is scheduled to begin treatment with IRd due to relapsed and/or refractory disease, and who meet other eligibility criteria.

Treatment arms and interventions

arm Groups

description
Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.
intervention Names
Drug: Ixazomib
Drug: Lenalidomide
Drug: Dexamethasone
label
Ixazomib + Lenalidomide + Dexamethasone

interventions

arm Group Labels
Ixazomib + Lenalidomide + Dexamethasone
description
Ixazomib capsules
name
Ixazomib
type
DRUG
arm Group Labels
Ixazomib + Lenalidomide + Dexamethasone
description
Lenalidomide capsules
name
Lenalidomide
type
DRUG
arm Group Labels
Ixazomib + Lenalidomide + Dexamethasone
description
Dexamethasone tablets
name
Dexamethasone
type
DRUG

Study design

observational Model: COHORT
time Perspective: PROSPECTIVE

Enrollment

count: 295
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
PFS was defined as the period from the start of ixazomib, lenalidomide, dexamethasone (IRd) therapy in standard medical care to the time of confirmed progressive disease (PD) or confirmed death (regardless of the cause of death), whichever was earlier. PFS was assessed by International Myeloma Working Group (IMWG) Criteria (2014 version). Per IMWG criteria, PD: serum M-component increase ≥ 0.5 g/dl or urine M-component increase ≥ 200 mg/24-hour/ difference between involved and uninvolved free light chain (FLC) levels increase \>10 mg/dl or bone marrow plasma cell ≥ 10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia.
measure
Progression-Free Survival (PFS)
time Frame
Up to 36 Months as a maximum

secondary Outcomes

description
PFS rate was defined as the percentage of participants who were alive and have not had disease progression at 12 months and 24 months after the date of start of study treatment. PFS was assessed by IMWG Criteria (2014 version). Per IMWG criteria, PD: serum M-component increase ≥ 0.5 g/dl or urine M-component increase ≥ 200 mg/24-hour/ difference between involved and uninvolved FLC levels increase \>10 mg/dl or bone marrow plasma cell ≥ 10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia.
measure
PFS Rate at 12 Months and 24 Months After the Start of Treatment
time Frame
12 months and 24 months
description
OS is defined as the period from the start of IRd therapy in standard medical care to the time when death (regardless of the cause of death) is confirmed.
measure
Overall Survival (OS)
time Frame
Up to 36 months as a maximum
description
Best response is defined as the cumulative numbers of participants who achieve each level of best response including partial response (PR), very good PR (VGPR) and complete response (CR) assessed with IMWG Criteria after each cycle of treatment. Per IMWG criteria, PR: ≥50% reduction of serum M protein+reduction in 24-hour urinary M protein by ≥90%/ to \<200 mg/24-hour or ≥50% decrease in difference between involved and uninvolved free light chain (FLC) levels/ ≥50% reduction in bone marrow plasma cells, if ≥30% at baseline/ ≥50% reduction in size of soft tissue plasmacytomas. VGPR: serum+urine M-protein detectable by immunofixation but not on electrophoresis/ ≥90% reduction in serum M-protein+urine M-protein level \<100 mg/24-hour. CR: negative immunofixation on serum+urine +disappearance of soft tissue plasmacytomas+\<5% plasma cells in bone marrow.
measure
Percentage of Participants Who Achieve or Maintain Any Best Response
time Frame
Up to 36 months as a maximum
description
TTNT will be measured as the period from the start of IRd therapy in standard medical care to the start of next treatment or time when death is confirmed (regardless of the cause of death), whichever is earlier.
measure
Time to Next Treatment (TTNT)
time Frame
Up to 36 months as a maximum
description
DOT is defined as the treatment duration of IRd therapy.
measure
Duration of Therapy (DOT)
time Frame
Up to 36 months as a maximum
measure
Percentage of Participants Who Continue to Receive Treatment at 12 Months and 24 Months After Start of Treatment
time Frame
12 months and 24 months
description
ORR is defined as the percentage of participants who achieve a best response of PR or better including stringent complete response (sCR), VGPR and PR assessed with IMWG Criteria, after the start of the study treatment.
measure
Overall Response Rate (ORR)
time Frame
Up to 36 months as a maximum
description
The percentage of participants of CR + VGPR is defined as the rate of participants who achieve a best response of VGPR or better (sCR, CR, or VGPR) according to the IMWG Criteria after the start of the IRd therapy.
measure
Percentage of Participants Who Achieve VGPR or Better (CR+VGPR)
time Frame
Up to 36 months as a maximum
description
EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/QOL scale. EORTC QLQ-C30 contains 28 questions (4-point scale where 1=Not at all \[best\] to 4=Very Much \[worst\]) and 2 questions (7-point scale where 1=Very poor \[worst\] to 7= Excellent \[best\]). Raw scores of Global Health Status in EORTC QLQ-C30 were linearly transformed to a total score between 0-100 and reported, with a high score indicating better QOL.
measure
Patient-Reported Outcome Health-Related Quality of Life (HRQoL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Global Health Status Score
time Frame
Baseline and End of Treatment (Up to 37 cycles, each cycle was of 28 days)
description
EORTC QLQ-MY20 has 20 items across 4 independent subscales, 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms, and side effects of treatment). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future. For the body image scale, higher scores = better body image. Higher score for the disease symptoms scale = higher level of symptomatology.
measure
Patient-Reported Outcome HRQoL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Score
time Frame
Baseline and End of Treatment (Up to 37 cycles, each cycle was of 28 days)
description
Rate of MRD will be calculated by the percentage of participants who are MRD-negative.
measure
Rate of Minimal Residual Disease (MRD) Negativity in Bone Marrow in Participants Who Achieved CR
time Frame
Up to 36 months as a maximum
description
RDI is defined as 100\*(Total amount of dose taken)/(Total prescribed dose of treated cycles), where total prescribed dose equals \[dose prescribed at enrollment\* number of prescribed doses per cycle\* the number of treated cycles\].
measure
Relative Dose Intensity (RDI)
time Frame
Up to 36 months as a maximum

Full study description

brief Summary: The purpose of this study is to investigate the real world effectiveness and safety of ixazomib in combination with lenalidomide and dexamethasone (IRd) in patients with relapsed and/or refractory multiple myeloma (RRMM), under conditions of standard medical care. In addition, an exploratory study of biomarkers will be conducted.
detailed Description: The drug being tested in this study is called Ixazomib. Ixazomib is being tested to treat people who have relapsed and/or refractory multiple myeloma (RRMM) under the conditions of standard medical care. This study is a non-interventional (observational), domestic, multicenter, prospective study in patients with RRMM. This study will look at the effectiveness and safety of ixazomib in combination with lenalidomide and dexamethasone in Japanese patients with RRMM as standard medical care. In addition, an exploratory study of biomarkers will be conducted in this study. The study will enroll approximately 300 patients. All participants will receive Ixazomib + Lenalidomide + Dexamethasone (IRd) therapy as standard medical care. This multi-center trial will be conducted in Japan. The overall time of observational period in this study will be 36 months. For each participant, the observation period will be from the start of IRd therapy until either 24 months after the enrollment date of the final patient to enroll, or until death or withdrawal of consent, whichever is earlier.

Source references

references

citation
Kogure Y, Handa H, Ito Y, Ri M, Horigome Y, Iino M, Harazaki Y, Kobayashi T, Abe M, Ishida T, Ito S, Iwasaki H, Kuroda J, Shibayama H, Sunami K, Takamatsu H, Tamura H, Hayashi T, Akagi K, Shinozaki T, Yoshida T, Mori I, Iida S, Maeda T, Kataoka K. ctDNA improves prognostic prediction for patients with relapsed/refractory MM receiving ixazomib, lenalidomide, and dexamethasone. Blood. 2024 Jun 6;143(23):2401-2413. doi: 10.1182/blood.2023022540.
pmid
38427753
type
DERIVED
citation
Horigome Y, Iino M, Harazaki Y, Kobayashi T, Handa H, Hiramatsu Y, Kuroi T, Tanimoto K, Matsue K, Abe M, Ishida T, Ito S, Iwasaki H, Kuroda J, Shibayama H, Sunami K, Takamatsu H, Tamura H, Hayashi T, Akagi K, Maeda T, Yoshida T, Mori I, Shinozaki T, Iida S. A prospective, multicenter, observational study of ixazomib plus lenalidomide-dexamethasone in patients with relapsed/refractory multiple myeloma in Japan. Ann Hematol. 2024 Feb;103(2):475-488. doi: 10.1007/s00277-023-05428-7. Epub 2023 Sep 11.
pmid
37695378
type
DERIVED