A Study of NINLARO® in Chinese Adults With Multiple Myeloma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Participants With Multiple Myeloma (MM) Participants diagnosed with MM (Newly Diagnosed Multiple Myeloma [NDMM]) using IMWG criteria and received a bortezomib-based triple-drug regimens for more than 2 cycles as initial therapy will be treated with ixazomib based regimens strictly following NINLARO® label will be observed prospectively for 24 months. |
Other: No intervention
This is a non-interventional study.
|
Outcome Measures
Primary Outcome Measures
- Progression Free Survival (PFS) [From the date of first administration of ixazomib therapy to the date of first documentation of progressive disease (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 PD/death, lost to follow-up, whichever occurs first assessed by 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, or >=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
- 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 International Myeloma Working Group (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.
- HRQOL Based on EuroQoL Group 5-Dimension 5-Level (EQ-5D-5L) [Up to 24 Months]
The EQ-5D-5L is self-administered PRO. Its descriptive system assesses health in five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to). This part of the EQ-5D questionnaire provides a descriptive profile that can be used to generate a health state profile. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The second part of the questionnaire consists of a visual analogue scale (VAS) on which the participant rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
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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.
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Eastern Cooperative Oncology Group (ECOG) 0-2.
Exclusion Criteria:
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Received a bortezomib-based triple-drug regimens as initial therapy less than 2 cycles.
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Failure to have fully recovered (that is, less than or equal to [<=] Grade 1 toxicity) from the reversible effects of prior chemotherapy.
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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.
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Has >=Grade 2 peripheral neuropathy (PN), or Grade 1 with pain on clinical examination at the time of enrollment.
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Previously been treated with ixazomib or participated in a study with ixazomib whether treated with ixazomib or not.
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Have gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing.
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Have an active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus positive.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hematology Department | Hefei | Anhui | China | 230000 |
| 2 | Hematology Department | Beijing | Beijing | China | 100020 |
| 3 | Hematology Department | Beijing | Beijing | China | 100096 |
| 4 | Hematology Department | Zhengzhou | Henan | China | 450004 |
| 5 | Hematology Department | Zhengzhou | Henan | China | 450052 |
| 6 | Hematology Department | Hohhot | Inner Mongolia Autonomous Region | China | 010050 |
| 7 | Hematology Department | Suzhou | Jiangsu | China | 215006 |
| 8 | Hematology Department | Nanchang | Jiangxi | China | 330006 |
| 9 | Hematology Department | Shenyang | Liaoning | China | 110022 |
| 10 | Hematology Department | Qingdao | Qingdao | China | 266071 |
| 11 | Hematology Department | Chengdu | Sichuan | China | 610000 |
| 12 | Hematology Department | Tianjin | Tianjin | China | 300052 |
Sponsors and Collaborators
- Takeda
Investigators
- Study Director: Study Director, Takeda
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- C15058