A Study of NINLARO® in Chinese Adults With Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- Other: No intervention
- Registration Number
- NCT05013190
- Lead Sponsor
- Takeda
- Brief Summary
The main aim of this study is to check side effects and results in adults with multiple myeloma after switching from a bortezomib-based to an Ixazomib-based treatment.
Treatment with NINLARO® will strictly follow the product label.
- Detailed Description
This is a non-interventional, prospective study of participants with MM. Participants will be treated with ixazomib based regimens until progression or unacceptable toxicity leading to a discontinuation or change in regimen, for a maximum of 26 cycles (24 months) (as per NINLARO® label) in real world clinical setting.
The study will enroll approximately 320 participants. The data will be collected prospectively in medical charts and will be recorded into electronic case report forms (eCRFs). All the participants will be assigned to a single observational cohort:
• Participants with MM
This multi-center trial will be conducted in China. The overall time for data collection in the study will be 24 months. Participants will be followed once every 3 months unless withdraw of informed consent form, death or lost to follow-up, termination of the study by the sponsor, whichever comes first.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 320
-
Who first diagnosed with MM using IMWG 2016 criteria.
-
Diagnosed with multiple myeloma using IMWG 2016 criteria and must be transplant ineligible as determined by their physician, or if transplant eligible, not expect to undergo transplant for at least 24 months after study enrollment.
o Stem cell harvest and mobilization regimen is acceptable if clinically indicated. But must first be confirmed by the Takeda Medical Monitor.
-
Who received bortezomib-based triple-drug regimens as frontline treatment, including bortezomib+cyclophosphamide+dexamethasone (VCD), bortezomib+lenalidomide dexamethasone (VRD), bortezomib+doxorubicin+dexamethasone (PAD), bortezomib+thalidomide+dexamethasone (VTD).
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Must achieve partial response (PR) as defined by IMWG 2016 criteria after bortezomib-based initial therapy.
-
Eastern Cooperative Oncology Group (ECOG) 0-2.
- Received a bortezomib-based triple-drug regimens as initial therapy less than 2 cycles.
- Failure to have fully recovered (that is, less than or equal to [<=] Grade 1 toxicity) from the reversible effects of prior chemotherapy.
- Have documented diagnosis of other cancers prior to the diagnosis of MM, excluding squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, which is considered cured with minimal risk of recurrence within 3 years.
- Has >=Grade 2 peripheral neuropathy (PN), or Grade 1 with pain on clinical examination at the time of enrollment.
- Previously been treated with ixazomib or participated in a study with ixazomib whether treated with ixazomib or not.
- Have gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing.
- Have an active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus positive.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants With Multiple Myeloma (MM) No intervention Participants diagnosed with MM (newly diagnosed multiple myeloma \[NDMM\] and first relapse multiple myeloma \[FRMM\]) using International Myeloma Working Group (IMWG) criteria who received a bortezomib/carfilzomib-based triple-drug regimens for more than 2 cycles as initial therapy, achieved at least partial response (PR) as defined by IMWG criteria, and are ready to start receiving an ixazomib containing therapy prescribed by their treating physician will be observed prospectively for 24 months.
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) at 24 Months From the date of first administration of ixazomib therapy to the date of first documentation of PD or death, lost to follow-up, whichever occurs first (up to 24 months) PFS:time date of first administration of ixazomib therapy to date of first documentation of progressive disease(PD)/death,lost to follow-up,whichever occurs first as per IMWG 2016 Response Criteria.PD:increase of 25 percent(%) from lowest confirmed response value in any one/more of following:Serum and Urine M-protein only in participants without measurable serum and urine M-protein levels,difference between involved/uninvolved free light chain (FLC) levels(absolute increase greater than(\>)10 milligram per deciliter \[mg/dL\]),and without measurable involved FLC levels, bone marrow plasma-cell% irrespective of baseline status (absolute increase must be ≥10%); appearance of new lesions, ≥50% increase from nadir in SPD of \>1 lesion/ ≥50% increase in the longest diameter of a previous lesion \>1 centimeter in short axis; ≥50% increase in circulating plasma cells (minimum of 200 cells per microliter \[mcL\]) if this is the only measure of disease. It will be analyzed using Kaplan-Meier method.
- Secondary Outcome Measures
Name Time Method Time to Next Treatment (TTNT) From the date of the first administration of ixazomib therapy to first dose of new treatment (up to 24 months) Time to next treatment will be defined as the time from the date of the first administration of ixazomib therapy to first dose of new treatment given after changing the therapy.
Percentage of Participants Achieving Very Good Partial Response (VGPR) Up to 24 months VGPR will be assessed as per IMWG 2016 Response Criteria, and defined as: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or greater than or equal to (\>=) 90% reduction in serum M-protein plus urine M-protein level less than (\<) 100 milligram (mg) per 24 hour (h).
Percentage of Participants Achieving Complete Response (CR) Up to 24 months CR will be assessed as per IMWG 2016 Response Criteria and defined as: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. For participants who only rely on serum FLC level as measurable lesions, in addition to meeting the above CR criteria, the ratio of serum FLC should return to normal under two consecutive assessments.
Percentage of Participants Achieving Stringent Complete Response (sCR) Up to 24 months sCR will be assessed as per IMWG 2016 Response Criteria, and defined as: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. For participants who only rely on serum FLC level as measurable lesions, in addition to meeting the above CR criteria, the ratio of serum FLC should return to normal under two consecutive assessments. Absence of clonal plasma cells in bone marrow biopsy by immunohistochemistry. Presence of bone clonal plasma cells is defined as κ/λ \>4:1 or \<1:2 ratio under two consecutive detection by immunohistochemical method (for participants with type κ and type λ respectively, and requiring a minimum of 100 plasma cells for analysis).
Duration of Ixazomib Therapy (DOT) Up to 24 months DOT will be defined as the time from the date of the first administration of ixazomib triplet therapy to the date of the last administration of ixazomib therapy.
Duration of CR Up to 24 months Duration of CR will be defined as time from first documented CR to the date of PD as per IMWG 2016 Response Criteria.
Overall Survival (OS) Up to 24 months OS will be defined as the time from enrollment to death from any cause.
Health-related Quality of Life (HRQOL) Based on European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC QLQ-MY20) Up to 24 months EORTC QLQ-MY20 is self-administered patient-reported outcomes (PRO) used to assess quality of life during the last 7 days. It has 20 items evaluated on 4 point rating scale ranging from: 1 (not at all), 2 (a little), 3 (quite a bit), 4 (very much). Total score ranges from 20 to 80. Higher scores represent worsening.
HRQOL Based on EORTC QLQ-C30 Up to 24 months EORTC QLQ-C30 is self-administered PRO which 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/quality of life (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 are converted into scale scores ranging from 0 to 100. For the functional scales and the global health status/QOL scale, higher scores represent better QOL; for the symptom scales, lower scores represent better QOL.
Treatment Satisfaction Questionnaire for Medication (TSQM-9) Up to 24 months TSQM-9 is self-administered PRO. It is a 9-item, validated, self-administered instrument used to assess participant's satisfaction or dissatisfaction with medication. The three domains assessed are effectiveness, convenience, and global satisfaction. The score of each of the 3 domains is based on an algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain.
Number of Participants Categorized Based on Healthcare Resource Utilization Up to 24 months Healthcare resource utilization will include outpatient visits to the study site, overnight hospital admissions, emergency department visits, and hospice care.
Number of Participants Categorized Based on Reason for Dose Reduction of Ixazomib Therapy Up to 24 months Number of Participants Categorized Based on Reason for Interruption of Ixazomib Therapy Up to 24 months Number of Participants Categorized Based on Reason for Discontinuation of Ixazomib Therapy Up to 24 months Relative Dose Intensity (RDI) Up to 24 months 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).
Number of Participants who Experience at Least one Adverse Event (AE) Up to 24 months Number of Participants Categorized Based on Occurrence of Second Primary Malignancies (SPM) Up to 24 months
Trial Locations
- Locations (12)
Anhui Cancer Hospital
🇨🇳Hefei, Anhui, China
Beijing Chao-Yang Hospital,Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Jishuitan Hospital
🇨🇳Beijing, Beijing, China
Henan Province People Hospital
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Zhenzhou University
🇨🇳Zhengzhou, Henan, China
Affiliated Hospital of Inner Mongolia Medical University
🇨🇳Hohhot, Inner Mongolia Autonomous Region, China
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
Qingdao Municipal Hospital
🇨🇳Qingdao, Qingdao, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
Shengjing Hospital affiliated to China Medical University
🇨🇳Shenyang, Liaoning, China