Relapsed and/or Refractory Multiple MyelomaNCT03433001
A Study in Relapsed and/or Refractory Multiple Myeloma Patients Treated With Ixazomib Plus Lenalidomide and Dexamethasone
An observational study of Relapsed and/or Refractory Multiple Myeloma, run by Takeda at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Relapsed and/or Refractory Multiple Myeloma
- What is being tested?
- Ixazomib, Lenalidomide and Dexamethasone
- Type of treatment
- Pill or oral medicine
- How many people
- 295 participants
- Where
- 1 siteJapan
- Study dates
- 2 Apr 2018to 11 Jun 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- 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.
Who may be able to join
- Men and women aged 20 years or older at the time of enrollment
- Patients with RRMM
- Participants who are scheduled to start IRd therapy
- Participants who can provide written informed consent of their own free will before the start of study treatment
- 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
Who cannot join
- Female Participants who are nursing or pregnant
- Participants who have been treated with ixazomib
- Participants with hypersensitivity to any of the components of IRd therapy, their analogs or excipients
- 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
- Participants who are not registered with, or comply with, the guidelines of the lenalidomide management program
- Participants who, in the judgement of the principal investigator or investigator(s), are considered to be unsuitable for enrolment into the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multicenter, Observational Study in Relapsed and/or Refractory Multiple Myeloma Patients Treated With Ixazomib Plus Lenalidomide and Dexamethasone
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.
Read the 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.
- Being tested
- Ixazomib, Lenalidomide, Dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IxazomibDrug
Ixazomib capsules
LenalidomideDrug
Lenalidomide capsules
DexamethasoneDrug
Dexamethasone tablets
| Study group | Role | What they receive |
|---|---|---|
| Ixazomib + Lenalidomide + Dexamethasone | 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. Receives: Drug: Ixazomib; Drug: Lenalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
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.
Measured: Up to 36 Months as a maximum
Secondary outcomes (14)
PFS Rate at 12 Months and 24 Months After the Start of Treatment
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.
Measured: 12 months and 24 months
Overall Survival (OS)
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.
Measured: Up to 36 months as a maximum
Percentage of Participants Who Achieve or Maintain Any Best Response
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.
Measured: Up to 36 months as a maximum
Time to Next Treatment (TTNT)
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.
Measured: Up to 36 months as a maximum
Duration of Therapy (DOT)
DOT is defined as the treatment duration of IRd therapy.
Measured: Up to 36 months as a maximum
Percentage of Participants Who Continue to Receive Treatment at 12 Months and 24 Months After Start of Treatment
Measured: 12 months and 24 months
Overall Response Rate (ORR)
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.
Measured: Up to 36 months as a maximum
Percentage of Participants Who Achieve VGPR or Better (CR+VGPR)
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.
Measured: Up to 36 months as a maximum
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
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.
Measured: Baseline and End of Treatment (Up to 37 cycles, each cycle was of 28 days)
Patient-Reported Outcome HRQoL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Score
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.
Measured: Baseline and End of Treatment (Up to 37 cycles, each cycle was of 28 days)
Rate of Minimal Residual Disease (MRD) Negativity in Bone Marrow in Participants Who Achieved CR
Rate of MRD will be calculated by the percentage of participants who are MRD-negative.
Measured: Up to 36 months as a maximum
Relative Dose Intensity (RDI)
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].
Measured: Up to 36 months as a maximum
Percentage of Participants With Bone Lesions (Bone Evaluation)
Measured: Up to 36 months as a maximum
Number of Participants Reporting One or More Treatment-Emergent AEs (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Measured: Up to 36 months as a maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start2 Apr 2018
- Primary completion11 Jun 2021
- Study completion11 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Relapsed and/or Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433001
- Sponsor's protocol ID
- C16042
- Other IDs
- JapicCTI-183860
- Status last verified
- May 2022
- First submitted
- 8 Feb 2018
- Last updated
- 7 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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.
Publications
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.
PubMed 38427753Horigome 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.
PubMed 37695378
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Observational Study in Relapsed and/or Refractory Multiple Myeloma Patients Treated With Ixazomib Plus Lenalidomide and Dexamethasone
- ClinicalTrials.gov ID
- NCT03433001
- Acronym / sponsor ID
- C16042
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 11 Jun 2021 (actual)
- Study completion
- 11 Jun 2021 (actual)
- First posted
- 14 Feb 2018 (actual)
- Results
- Posted 7 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ixazomib + Lenalidomide + Dexamethasone | – | Drug: Ixazomib, Drug: Lenalidomide, Drug: DexamethasoneParticipants 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- Men and women aged 20 years or older at the time of enrollment
- Patients with RRMM
- Participants who are scheduled to start IRd therapy
- Participants who can provide written informed consent of their own free will before the start of study treatment
- 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
Key exclusion criteria (6 listed)
- Female Participants who are nursing or pregnant
- Participants who have been treated with ixazomib
- Participants with hypersensitivity to any of the components of IRd therapy, their analogs or excipients
- 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
- Participants who are not registered with, or comply with, the guidelines of the lenalidomide management program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IxazomibIxazomib capsules | Drug | Ixazomib + Lenalidomide + Dexamethasone |
| LenalidomideLenalidomide capsules | Drug | Ixazomib + Lenalidomide + Dexamethasone |
| DexamethasoneDexamethasone tablets | Drug | Ixazomib + Lenalidomide + Dexamethasone |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Up to 36 Months as a maximum
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.
14 secondary outcomes
PFS Rate at 12 Months and 24 Months After the Start of Treatment
Time frame: 12 months and 24 months
Overall Survival (OS)
Time frame: Up to 36 months as a maximum
Percentage of Participants Who Achieve or Maintain Any Best Response
Time frame: Up to 36 months as a maximum
Time to Next Treatment (TTNT)
Time frame: Up to 36 months as a maximum
Duration of Therapy (DOT)
Time frame: Up to 36 months as a maximum
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
Overall Response Rate (ORR)
Time frame: Up to 36 months as a maximum
Percentage of Participants Who Achieve VGPR or Better (CR+VGPR)
Time frame: Up to 36 months as a maximum
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)
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)
Rate of Minimal Residual Disease (MRD) Negativity in Bone Marrow in Participants Who Achieved CR
Time frame: Up to 36 months as a maximum
Relative Dose Intensity (RDI)
Time frame: Up to 36 months as a maximum
Percentage of Participants With Bone Lesions (Bone Evaluation)
Time frame: Up to 36 months as a maximum
Number of Participants Reporting One or More Treatment-Emergent AEs (TEAEs)
Time frame: Up to 36 months as a maximum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38427753Kogure 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.
- Derived from this study: PubMed 37695378Horigome 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.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsed and/or Refractory Multiple Myeloma, run by Takeda at 1 site in Japan.
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 5 inclusion and 6 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 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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?
Yes. Results are posted in the registry (first posted 7 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression-Free Survival (PFS) (time frame: Up to 36 Months as a maximum). 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 NCT03433001, which also lists 2 linked publications.
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 7 Dec 2023.