Covid 19 Research using Clinical Trials (Home Page)
HP:0006775: Multiple myelomaHPO
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (2)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1285 | Ixazomib Placebo Wiki | 1.00 |
| drug1284 | Ixazomib Wiki | 0.71 |
Correlated MeSH Terms (2)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D009101 | Multiple Myeloma NIH | 1.00 |
| D054219 | Neoplasms, Plasma Cell NIH | 1.00 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There is one clinical trial.
Clinical Trials
1 A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Patients With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation
The purpose of this study is to determine the effect of ixazomib maintenance therapy on progression-free survival (PFS) compared with placebo, in participants in China with newly diagnosed multiple myeloma (NDMM) who have had a major response [complete response (CR), very good partial response (VGPR), or partial response (PR)] to initial therapy and who have not undergone stem-cell transplantation (SCT). This study is a China continuation of the global study C16021 (NCT02312258).
NCT03748953 Multiple Myeloma Drug: Ixazomib Drug: Ixazomib Placebo MeSH:Multiple Myeloma Neoplasms, Plasma Cell
HPO:Multiple myeloma
Primary Outcomes
Description: PFS is defined as the time from randomization to the first occurrence of PD as evaluated by an independent review committee (IRC) or death from any cause, whichever occurs first. PD is defined as >=25% increase from lowest value in serum M component or urine M-component; difference between involved and uninvolved free light chain (FLC) levels (absolute increase >10 mg/dL); bone marrow plasma cell percent >/=10%; new bone lesions or soft tissue plasmacytomas development or definite increase in existing bone lesions/soft tissue plasmacytomas size; hypercalcaemia development.
Measure: Progression-Free Survival (PFS) Time: From randomization to progressive disease (PD) or death from any cause (until 60 death events or the full analysis (FA) for overall survival (OS) in global study, whichever occurs later [approximately 88 months])
Secondary Outcomes
Description: OS is measured as the time of randomization to the date of death.
Measure: Overall Survival (OS) Time: From randomization to every 12 weeks during follow-up after PD on next line therapy (until 60 death events or the FA for OS in global study, whichever occurs later [approximately 88 months])
Description: Response will be assessed as per IMWG criteria. Best response will include partial responses (PR), very good partial response (VGPR) and complete response (CR). PR is defined as >=50% reduction of serum M-component, urinary M- component by >=90% to <200 mg/24-hour reduction; >=50% in the difference between involved and uninvolved FLC; bone marrow plasma cells (PC) >/= 30%; reduction >/= 50% reduction in the soft tissue size. VGPR is defined as serum or urine M-component detectable by immunofixation but not on electrophoresis; >=90% reduction in serum or urine M-component level <100 mg/24 hour. CR is defined as negative immunofixation on the serum and urine; soft tissue plasmacytomas disappearance; <5% PCs in bone marrow.
Measure: Percentage of Participants who Achieve or Maintain Best Response Before PD or up to Subsequent Therapy Time: From randomization to PD or death from any cause (until 60 death events or the FA for OS in global study, whichever occurs later [approximately 88 months])
Description: Duration of CR is defined as the time from the date of randomization or the date of CR to the date of first documentation of PD. CR is defined as negative immunofixation on the serum and urine; soft tissue plasmacytomas disappearance; <5% PCs in bone marrow.
Measure: Duration of Complete Response (CR) Time: From randomization to PD or death from any cause (until 60 death events or the FA for OS in global study, whichever occurs later [approximately 88 months])
Description: TTP is defined as the time from the date of randomization to the date of first documentation of PD. PD is defined as >=25% increase from lowest value in serum M component or urine M-component; difference between involved and uninvolved FLC levels (absolute increase >10 mg/dL); bone marrow plasma cell percent >/=10%; new bone lesions or soft tissue plasmacytomas development or definite increase in existing bone lesions/soft tissue plasmacytomas size; hypercalcaemia development.
Measure: Time to Progression (TTP) Time: From randomization to PD or death from any cause (until 60 death events or the FA for OS in global study, whichever occurs later [approximately 88 months])
Description: PFS2 is defined as the time from the start of next-line therapy to second disease progression using IMWG criteria, or death from any cause. PD is defined as >=25% increase from lowest value in serum M component or urine M-component; difference between involved and uninvolved FLC levels (absolute increase >10 mg/dL); bone marrow plasma cell percent >/=10%; new bone lesions or soft tissue plasmacytomas development or definite increase in existing bone lesions/soft tissue plasmacytomas size; hypercalcaemia development.
Measure: Second Progression-Free Survival (PFS2) Time: Every 12 weeks from the start of next-line therapy to second disease progression or death (until 60 death events or the FA for OS in global study, whichever occurs later [approximately 88 months])
Description: TTNT is defined as the time from the date of randomization to the date of the first dose of next-line antineoplastic therapy.
Measure: Time to Next-Line Therapy (TTNT) Time: From randomization to PD or death from any cause (until 60 death events or the FA for OS in global study, whichever occurs later [approximately 88 months])
Description: Time to end of next-line therapy is defined as the time from the date of randomization to the date of last dose of next-line antineoplastic therapy.
Measure: Time to End of the Next Line of Therapy Time: From randomization to PD or death from any cause (until 60 death events or the FA for OS in global study, whichever occurs later [approximately 88 months])
Description: Duration of next-line therapy is defined as the time from the date of onset of next-line therapy to the date of the last dose or PD2. PD2 is s defined as >=25% increase from lowest value in serum M component or urine M-component; difference between involved and uninvolved FLC levels (absolute increase >10 mg/dL); bone marrow plasma cell percent >/=10%; new bone lesions or soft tissue plasmacytomas development or definite increase in existing bone lesions/soft tissue plasmacytomas size; hypercalcaemia development.
Measure: Duration of Next-Line Therapy Time: From start of next-line therapy up to PD2 (until approximately 60 death events have been reported or the FA for OS in global study, whichever occurs later, or termination of the study by the sponsor [approximately 88 months])
Description: Percentage of participants with a new primary malignancy will be reported.
Measure: Percentage of Participants With A New Primary Malignancy Time: From randomization to PD or death from any cause (until 60 death events or the FA for OS in global study, whichever occurs later [approximately 88 months])
Description: MRD negativity is defined as absence of MRD and MRD positivity is defined as presence of MRD. MRD will be assessed using next generation sequencing (NGS) methodology.
Measure: Percentage of Participants with Conversion from Minimal Residual Disease (MRD) Positive to MRD Negative, or the Maintenance of MRD Negativity Time: Up to 26 cycles (each cycle of 28 days), 24 months
Description: OS will be measured as the time from the date of randomization to the date of death. High-risk population will include but not be limited to participants carrying mutations including, but not limited to, del17, t(4;14), or t(14;16).
Measure: Overall (OS) Survival in High-Risk Cytogenetic Population Time: From randomization to every 12 weeks during follow-up after PD on next line therapy (until 60 death events or the FA for OS in global study, whichever occurs later [approximately 88 months])
Description: PFS is defined as the time from randomization to the first occurrence of PD as evaluated by an IRC. PD is defined as >=25% increase from lowest value in serum M component or urine M-component; difference between involved and uninvolved FLC levels (absolute increase >10 mg/dL); bone marrow plasma cell percent >/=10%; new bone lesions or soft tissue plasmacytomas development or definite increase in existing bone lesions/soft tissue plasmacytomas size; hypercalcaemia development. High-risk population will include but not be limited to participants carrying mutations including, but not limited to, del17, t(4;14), or t(14;16).
Measure: Progression-Free Survival (PFS) in High-Risk Cytogenetic Population Time: From randomization to PD or death from any cause (until 60 death events or the FA for OS in global study, whichever occurs later [approximately 88 months])
Description: ECOG performance status will assess participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (>50% of waking hrs), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead.
Measure: Eastern Cooperative Oncology Group (ECOG) Performance Status Time: First dose of study drug through 30 days after last dose of study drug (Up to 25 months)
Description: A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after the last dose of study drug.
Measure: Percentage of Participants with Serious Adverse Events and Adverse Events (AEs) Time: First dose of study drug through 30 days after last dose of study drug (Up to 25 months)
Description: Clinical laboratory evaluations will be performed by a central laboratory. The number of participants with any markedly abnormal standard safety laboratory values collected throughout study.
Measure: Number of Participants with Any Markedly Abnormal Standard Safety Laboratory Values Time: From First dose date of study drug through 30 days after the last dose of study drug (Up to 25 months)
Description: The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC) QLQ-C30 is completed by the participant. The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1=not at all (best) to 4=very Much (worst) and 2 questions answered on a 7-point scale where 1=very poor (worst) to 7= excellent (best).
Measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC) QLQ-C30 Time: From randomization to second disease progression or death (until 60 death events or the FA for OS in global study, whichever occurs later [approximately 88 months])
Description: Participants frailty status will be assessed on the basis of 4 components: age (<75, 75- 80, and>80 years correspond to frailty scores of 0, 1, and 2, respectively), the charlson comorbidity scoring system without age weighting (scores of ≤ 1 and ≥ 2 correspond to frailty scores of 0 and 1, respectively), the katz index of independence in activities of daily living (scores of >4 and ≤ 4 correspond to frailty scores of 0 and 1, respectively) and lawton instrumental activities of daily living scale (scores of >5 and ≤ 5 correspond to frailty scores of 0 and 1, respectively). The sum of the 4 frailty scores equals the total frailty score. A total frailty score of 0 corresponds to a frailty status of fit; a total score of 1, to unfit; and a total score of 2 or more, to frail. PFS is defined as the time from randomization to the first occurrence of PD as evaluated by an IRC. OS will be measured as the time from the date of randomization to the date of death.
Measure: Correlation between Frailty Status and PFS and OS Time: From randomization to every 12 weeks during follow-up after PD on next line therapy (until 60 death events or the FA for OS in global study, whichever occurs later [approximately 88 months])
Measure: Plasma Concentration of Ixazomib Time: Cycle 1 Day 1 (1 and 4 hours post dose), Cycle 1 pre-dose on Days 8 and 15; Cycle 2 pre-dose on Days 1 and 8; Cycle 3-10 pre-dose on Day 1; Cycle 5 pre-dose on Day 8 (only for participants who have dose escalated after Cycle 4), each cycle of 28 days
Description: PN is defined as the treatment-emergent adverse event in the high-level term of peripheral neuropathies not elsewhere classified (NEC) according to the Medical Dictionary for Regulatory Activities (MedDRA). A PN event is considered as resolved if its final outcome is resolved with no subsequent PN event of the same preferred term occurring on the resolution date or the day before and after. Time to resolution is defined as the time from the initial onset date (inclusive) to the resolution date for resolved events.
Measure: Time to Resolution of Peripheral Neuropathy (PN) Events Time: From First dose date of study drug through 30 days after the last dose of study drug (Up to 25 months)
Description: PN is defined as the treatment-emergent adverse event in the high-level term of peripheral neuropathies not elsewhere classified (NEC) according to the MedDRA. A PN event is considered to be improved if the event improves from the maximum grade; that is, all the grades recorded after the maximum grade are less than the maximum grade. Time to improvement is defined as the time from the initial onset date (inclusive) of the maximum grade to the first onset date that the toxicity grade is below the maximum grade with no higher grade thereafter, or the resolution date, whichever occurs first.
Measure: Time to Improvement of PN Events Time: From First dose date of study drug through 30 days after the last dose of study drug (Up to 25 months)
HPO Nodes
Primary Outcomes
Description: PFS is defined as the time from randomization to the first occurrence of PD as evaluated by an independent review committee (IRC) or death from any cause, whichever occurs first. PD is defined as >=25% increase from lowest value in serum M component or urine M-component; difference between involved and uninvolved free light chain (FLC) levels (absolute increase >10 mg/dL); bone marrow plasma cell percent >/=10%; new bone lesions or soft tissue plasmacytomas development or definite increase in existing bone lesions/soft tissue plasmacytomas size; hypercalcaemia development.
Measure: Progression-Free Survival (PFS) Time: From randomization to progressive disease (PD) or death from any cause (until 60 death events or the full analysis (FA) for overall survival (OS) in global study, whichever occurs later [approximately 88 months])Secondary Outcomes
Description: OS is measured as the time of randomization to the date of death.
Measure: Overall Survival (OS) Time: From randomization to every 12 weeks during follow-up after PD on next line therapy (until 60 death events or the FA for OS in global study, whichever occurs later [approximately 88 months])Description: Response will be assessed as per IMWG criteria. Best response will include partial responses (PR), very good partial response (VGPR) and complete response (CR). PR is defined as >=50% reduction of serum M-component, urinary M- component by >=90% to <200 mg/24-hour reduction; >=50% in the difference between involved and uninvolved FLC; bone marrow plasma cells (PC) >/= 30%; reduction >/= 50% reduction in the soft tissue size. VGPR is defined as serum or urine M-component detectable by immunofixation but not on electrophoresis; >=90% reduction in serum or urine M-component level <100 mg/24 hour. CR is defined as negative immunofixation on the serum and urine; soft tissue plasmacytomas disappearance; <5% PCs in bone marrow.
Measure: Percentage of Participants who Achieve or Maintain Best Response Before PD or up to Subsequent Therapy Time: From randomization to PD or death from any cause (until 60 death events or the FA for OS in global study, whichever occurs later [approximately 88 months])Description: Duration of CR is defined as the time from the date of randomization or the date of CR to the date of first documentation of PD. CR is defined as negative immunofixation on the serum and urine; soft tissue plasmacytomas disappearance; <5% PCs in bone marrow.
Measure: Duration of Complete Response (CR) Time: From randomization to PD or death from any cause (until 60 death events or the FA for OS in global study, whichever occurs later [approximately 88 months])Description: TTP is defined as the time from the date of randomization to the date of first documentation of PD. PD is defined as >=25% increase from lowest value in serum M component or urine M-component; difference between involved and uninvolved FLC levels (absolute increase >10 mg/dL); bone marrow plasma cell percent >/=10%; new bone lesions or soft tissue plasmacytomas development or definite increase in existing bone lesions/soft tissue plasmacytomas size; hypercalcaemia development.
Measure: Time to Progression (TTP) Time: From randomization to PD or death from any cause (until 60 death events or the FA for OS in global study, whichever occurs later [approximately 88 months])Description: PFS2 is defined as the time from the start of next-line therapy to second disease progression using IMWG criteria, or death from any cause. PD is defined as >=25% increase from lowest value in serum M component or urine M-component; difference between involved and uninvolved FLC levels (absolute increase >10 mg/dL); bone marrow plasma cell percent >/=10%; new bone lesions or soft tissue plasmacytomas development or definite increase in existing bone lesions/soft tissue plasmacytomas size; hypercalcaemia development.
Measure: Second Progression-Free Survival (PFS2) Time: Every 12 weeks from the start of next-line therapy to second disease progression or death (until 60 death events or the FA for OS in global study, whichever occurs later [approximately 88 months])Description: TTNT is defined as the time from the date of randomization to the date of the first dose of next-line antineoplastic therapy.
Measure: Time to Next-Line Therapy (TTNT) Time: From randomization to PD or death from any cause (until 60 death events or the FA for OS in global study, whichever occurs later [approximately 88 months])Description: Time to end of next-line therapy is defined as the time from the date of randomization to the date of last dose of next-line antineoplastic therapy.
Measure: Time to End of the Next Line of Therapy Time: From randomization to PD or death from any cause (until 60 death events or the FA for OS in global study, whichever occurs later [approximately 88 months])Description: Duration of next-line therapy is defined as the time from the date of onset of next-line therapy to the date of the last dose or PD2. PD2 is s defined as >=25% increase from lowest value in serum M component or urine M-component; difference between involved and uninvolved FLC levels (absolute increase >10 mg/dL); bone marrow plasma cell percent >/=10%; new bone lesions or soft tissue plasmacytomas development or definite increase in existing bone lesions/soft tissue plasmacytomas size; hypercalcaemia development.
Measure: Duration of Next-Line Therapy Time: From start of next-line therapy up to PD2 (until approximately 60 death events have been reported or the FA for OS in global study, whichever occurs later, or termination of the study by the sponsor [approximately 88 months])Description: Percentage of participants with a new primary malignancy will be reported.
Measure: Percentage of Participants With A New Primary Malignancy Time: From randomization to PD or death from any cause (until 60 death events or the FA for OS in global study, whichever occurs later [approximately 88 months])Description: MRD negativity is defined as absence of MRD and MRD positivity is defined as presence of MRD. MRD will be assessed using next generation sequencing (NGS) methodology.
Measure: Percentage of Participants with Conversion from Minimal Residual Disease (MRD) Positive to MRD Negative, or the Maintenance of MRD Negativity Time: Up to 26 cycles (each cycle of 28 days), 24 monthsDescription: OS will be measured as the time from the date of randomization to the date of death. High-risk population will include but not be limited to participants carrying mutations including, but not limited to, del17, t(4;14), or t(14;16).
Measure: Overall (OS) Survival in High-Risk Cytogenetic Population Time: From randomization to every 12 weeks during follow-up after PD on next line therapy (until 60 death events or the FA for OS in global study, whichever occurs later [approximately 88 months])Description: PFS is defined as the time from randomization to the first occurrence of PD as evaluated by an IRC. PD is defined as >=25% increase from lowest value in serum M component or urine M-component; difference between involved and uninvolved FLC levels (absolute increase >10 mg/dL); bone marrow plasma cell percent >/=10%; new bone lesions or soft tissue plasmacytomas development or definite increase in existing bone lesions/soft tissue plasmacytomas size; hypercalcaemia development. High-risk population will include but not be limited to participants carrying mutations including, but not limited to, del17, t(4;14), or t(14;16).
Measure: Progression-Free Survival (PFS) in High-Risk Cytogenetic Population Time: From randomization to PD or death from any cause (until 60 death events or the FA for OS in global study, whichever occurs later [approximately 88 months])Description: ECOG performance status will assess participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (>50% of waking hrs), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead.
Measure: Eastern Cooperative Oncology Group (ECOG) Performance Status Time: First dose of study drug through 30 days after last dose of study drug (Up to 25 months)Description: A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after the last dose of study drug.
Measure: Percentage of Participants with Serious Adverse Events and Adverse Events (AEs) Time: First dose of study drug through 30 days after last dose of study drug (Up to 25 months)Description: Clinical laboratory evaluations will be performed by a central laboratory. The number of participants with any markedly abnormal standard safety laboratory values collected throughout study.
Measure: Number of Participants with Any Markedly Abnormal Standard Safety Laboratory Values Time: From First dose date of study drug through 30 days after the last dose of study drug (Up to 25 months)Description: The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC) QLQ-C30 is completed by the participant. The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1=not at all (best) to 4=very Much (worst) and 2 questions answered on a 7-point scale where 1=very poor (worst) to 7= excellent (best).
Measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC) QLQ-C30 Time: From randomization to second disease progression or death (until 60 death events or the FA for OS in global study, whichever occurs later [approximately 88 months])Description: Participants frailty status will be assessed on the basis of 4 components: age (<75, 75- 80, and>80 years correspond to frailty scores of 0, 1, and 2, respectively), the charlson comorbidity scoring system without age weighting (scores of ≤ 1 and ≥ 2 correspond to frailty scores of 0 and 1, respectively), the katz index of independence in activities of daily living (scores of >4 and ≤ 4 correspond to frailty scores of 0 and 1, respectively) and lawton instrumental activities of daily living scale (scores of >5 and ≤ 5 correspond to frailty scores of 0 and 1, respectively). The sum of the 4 frailty scores equals the total frailty score. A total frailty score of 0 corresponds to a frailty status of fit; a total score of 1, to unfit; and a total score of 2 or more, to frail. PFS is defined as the time from randomization to the first occurrence of PD as evaluated by an IRC. OS will be measured as the time from the date of randomization to the date of death.
Measure: Correlation between Frailty Status and PFS and OS Time: From randomization to every 12 weeks during follow-up after PD on next line therapy (until 60 death events or the FA for OS in global study, whichever occurs later [approximately 88 months])Measure: Plasma Concentration of Ixazomib Time: Cycle 1 Day 1 (1 and 4 hours post dose), Cycle 1 pre-dose on Days 8 and 15; Cycle 2 pre-dose on Days 1 and 8; Cycle 3-10 pre-dose on Day 1; Cycle 5 pre-dose on Day 8 (only for participants who have dose escalated after Cycle 4), each cycle of 28 days
Description: PN is defined as the treatment-emergent adverse event in the high-level term of peripheral neuropathies not elsewhere classified (NEC) according to the Medical Dictionary for Regulatory Activities (MedDRA). A PN event is considered as resolved if its final outcome is resolved with no subsequent PN event of the same preferred term occurring on the resolution date or the day before and after. Time to resolution is defined as the time from the initial onset date (inclusive) to the resolution date for resolved events.
Measure: Time to Resolution of Peripheral Neuropathy (PN) Events Time: From First dose date of study drug through 30 days after the last dose of study drug (Up to 25 months)Description: PN is defined as the treatment-emergent adverse event in the high-level term of peripheral neuropathies not elsewhere classified (NEC) according to the MedDRA. A PN event is considered to be improved if the event improves from the maximum grade; that is, all the grades recorded after the maximum grade are less than the maximum grade. Time to improvement is defined as the time from the initial onset date (inclusive) of the maximum grade to the first onset date that the toxicity grade is below the maximum grade with no higher grade thereafter, or the resolution date, whichever occurs first.
Measure: Time to Improvement of PN Events Time: From First dose date of study drug through 30 days after the last dose of study drug (Up to 25 months)