glycine and Recrudescence

glycine has been researched along with Recrudescence in 50 studies

Research

Studies (50)

Authors

Clinical Trials (7)

Trial Overview

Trial Outcomes

Event-Free Survival (EFS)

EFS was defined as the time from randomization until treatment failure, relapse from remission, or death from any cause, whichever occurs first. Treatment failure was defined as failure to achieve complete remission (CR) by Week 24. CR: Bone marrow blasts <5% and no Auer rods; absence of extramedullary disease; Absolute neutrophil count (ANC) ≥1.0 × 10^9 per litre (10^9/L) (1000 per microlitre [1000/μL]); platelet count ≥100 × 10^9/L (100,000/μL); independence of red blood cell transfusions. Participants who had an EFS event (relapse or death) after, 2 or more missing disease assessments were censored at the last adequate disease assessment documenting no relapse before the missing assessments. The reported data represents the Kaplan-Meier median value. (NCT03173248)
Timeframe: Up to Week 24

Combined Response Rate During the Induction Phase in Newly Diagnosed Multiple Myeloma (NDMM) Participants

Combined Response Rate is the percentage of participants with Complete Response (CR), including stringent Complete Response (sCR), and Very Good Partial Response (VGPR) according to the International Myeloma Working Group (IMWG) criteria during the Induction Phase (Cycles 1-13, 28-day cycles). CR=negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow. VGPR=serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% reduction in serum M-component plus urine M-component <100 mg/24 hour. (NCT02046070)
Timeframe: Day 1 of Cycles 1-13, 28-day cycles (Up to 1 year)

Duration of Response (DOR) in NDMM Participants

DOR is defined as the time from the date of first documentation of a confirmed PR or better to the date of first documented PD up to the initiation of alternative therapy. (NCT02046070)
Timeframe: Up to 45 Months

Duration of Response (DOR) in RRMM Participants

DOR is defined as the time from the date of first documentation of a confirmed PR or better to the date of first documented PD up to the alternative therapy. (NCT02046070)
Timeframe: Up to 45 months

Overall Response Rate (ORR) in Relapsed and/or Refractory Multiple Myeloma (RRMM) Participants

ORR is the percentage of participants with CR, VGPR or PR according to IMWG criteria. CR=negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells (PC) in bone marrow. VGPR=serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% reduction in serum M-component plus urine M-component <100 mg/24 hour. PR=50% reduction of serum M-protein and reduction in 24 hour urine M-protein by 90% or <200 mg/24 hour or decrease 50% difference between involved free light chain (FLC) levels or 50% reduction in bone marrow plasma cells if baseline percentage was 30%; and if present at Baseline, 50% reduction in the size of soft tissue plasmacytomas. (NCT02046070)
Timeframe: Day 1 of each 28 day cycle (Up to 45 months)

Progression Free Survival (PFS) in NDMM Participants

PFS is defined as the time from the date of first dose of study treatment to the date of the first documented disease progression or death. (NCT02046070)
Timeframe: Up to 45 months

Progression Free Survival (PFS) in RRMM Participants

PFS is defined as the time from the date of first dose of study treatment to the date of the first documented disease progression or death. (NCT02046070)
Timeframe: Up to 45 months

Time to Progression (TTP) in NDMM Participants

TTP is defined as the time from the date of first dose of study treatment to the date of first documentation of disease progression. (NCT02046070)
Timeframe: Up to 45 months

Time to Progression (TTP) in RRMM Participants

TTP is defined as the time from the date of first dose of study treatment to the date of first documentation of disease progression. (NCT02046070)
Timeframe: Up to 45 months

Time to Response (TTR) in NDMM Participants During the Induction Phase

TTR is defined as the time interval from the date of the first dose of study treatment to the date of the first documented confirmed response of PR or better up to the initiation of alternative therapy in a participant who responded. (NCT02046070)
Timeframe: Up to 1 year

Time to Response (TTR) in RRMM Participants

TTR is defined as the time interval from the date of the first dose of study treatment to the date of the first documented confirmed response of PR or better up to the alternative therapy in a participant who responded. (NCT02046070)
Timeframe: Up to 45 months

AUCtau: Area Under the Concentration-time Curve During a Dosing Interval for Ixazomib in NDMM Participants

(NCT02046070)
Timeframe: Cycle 1 Days 1 and 15 predose and at multiple timepoints (up to 168 hours) postdose

AUCtau: Area Under the Concentration-time Curve During a Dosing Interval for Ixazomib in RRMM Participants

(NCT02046070)
Timeframe: Cycle 1 Days 1 and 15 predose and at multiple timepoints (up to 168 hours) postdose

Change From Baseline in EORTC Quality of Life Questionnaire (QLQ-C30) in RRMM Participants

EORTC QLQ-C30 is a patient completed 30 item questionnaire that consists of 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 patient evaluates their health status over the previous week. There are 28 questions answered on a 4-point scale where1=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). All of the scales and single-item measures are transformed to a score:0 to 100. For functioning scales and global QOL higher scores indicate better functioning (a positive change from Baseline indicates improvement); for symptom scales higher scores indicate more severe symptoms (a negative change from Baseline indicates improvement). (NCT02046070)
Timeframe: Baseline (Day 1 of Cycle 1), Day 1 of End of Treatment (EOT) (Up to 45 months)

Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) During the Induction Phase in NDMM Participants

EORTC QLQ-C30 is a patient completed 30 item questionnaire that consists of 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 patient evaluates their health status over the previous week. There are 28 questions answered on a 4-point scale where1=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). All of the scales and single-item measures are transformed to a score:0 to 100. For functioning scales and global QOL higher scores indicate better functioning (a positive change from Baseline indicates improvement); for symptom scales higher scores indicate more severe symptoms (a negative change from Baseline indicates improvement). (NCT02046070)
Timeframe: Baseline (BL) (Day 1 of Cycle 1), Day 1 of Cycle 13 (Up to 1 year)

Cmax: Maximum Observed Plasma Concentration for Ixazomib in NDMM Participants

(NCT02046070)
Timeframe: Cycle 1 Days 1 and 15 predose and at multiple timepoints (up to 168 hours) postdose

Cmax: Maximum Observed Plasma Concentration for Ixazomib in RRMM Participants

(NCT02046070)
Timeframe: Cycle 1 Days 1 and 15 predose and at multiple timepoints (up to 168 hours) postdose

Number of Participants With Adverse Events (AEs), Grade 3 or Higher AEs, AEs Resulting in Treatment Discontinuation, AEs Resulting in Dose Reduction and Serious Adverse Events (SAEs) in NDMM Participants

"An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. This includes any newly occurring event, or a previous condition that has increased in severity or frequency since the administration of study drug.~A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. Relationship of each AE to study drug was determined by the Investigator." (NCT02046070)
Timeframe: First dose of study drug through 30 days after last dose of drug (Up to 45 months)

Number of Participants With AEs, Grade 3 or Higher AEs, AEs Resulting in Treatment Discontinuation, AEs Resulting in Dose Reduction, SAEs in RRMM Participants

"An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment.~A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. Relationship of each AE to study drug was determined by the Investigator." (NCT02046070)
Timeframe: First dose of study drug through 30 days after last dose of drug (Up to 45 months)

Number of Participants With AEs, SAEs, AEs Resulting in Discontinuation and AEs Resulting in Dose Reduction in NDMM Participants Remaining on Treatment After 13 Cycles

"An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. This includes any newly occurring event, or a previous condition that has increased in severity or frequency since the administration of study drug.~A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. Relationship of each AE to study drug was determined by the Investigator." (NCT02046070)
Timeframe: First dose of study drug through 30 days after the last dose of drug (Up to 45 months)

Percentage of Participants With (CR + VGPR), CR, VGPR, PR, SD and PD in RRMM Participants

Percentage of participants with CR + VGPR + PR (ORR), CR, VGPR, PR, SD, PD according to IMWG criteria. CR=negative immunofixation of serum and urine; disappearance of soft tissue plasmacytomas;<5% PC in bone marrow. VGPR=serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% reduction in serum M-component plus urine M-component <100 mg/24 hour. PR=50% reduction of serum M-protein and reduction in 24 hour urine M-protein by 90% or <200 mg/24 hour or decrease 50% difference between involved FLC levels or 50% reduction in bone marrow plasma cells if baseline percentage was 30%; and if present at Baseline, 50% reduction in the size of soft tissue plasmacytomas. SD=not meeting criteria for VGPR, PR or PD. PD=25% increase in lowest value any of the following: serum M-component, urine M-component, difference between involved and uninvolved FLC levels, bone marrow PC percentage; new or increase in size of existing bone lesions or soft tissue plasmacytomas. (NCT02046070)
Timeframe: Day 1 of each 28-day Cycle (Up to 45 months)

Percentage of Participants With CR + VGPR + PR (ORR), CR + VGPR, CR, VGPR, PR, SD and PD Throughout the Entire Treatment Period in NDMM Participants

Percentage of participants with CR + VGPR + PR (ORR), CR, VGPR, PR, SD, PD according to IMWG criteria. CR=negative immunofixation of serum and urine; disappearance of soft tissue plasmacytomas;<5% PC in bone marrow. VGPR=serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% reduction in serum M-component plus urine M-component <100 mg/24 hour. PR=50% reduction of serum M-protein and reduction in 24 hour urine M-protein by 90% or <200 mg/24 hour or decrease 50% difference between involved FLC levels or 50% reduction in bone marrow plasma cells if baseline percentage was 30%; and if present at Baseline, 50% reduction in the size of soft tissue plasmacytomas. SD=not meeting criteria for VGPR, PR or PD. PD=25% increase in lowest value any of the following: serum M-component, urine M-component, difference between involved and uninvolved FLC levels, bone marrow PC percentage; new or increase in size of existing bone lesions or soft tissue plasmacytomas. (NCT02046070)
Timeframe: Day 1 of each 28-day Cycle (Up to 45 months)

Percentage of Participants With CR + VGPR + PR (ORR), CR, VGPR, PR and Stable Disease (SD), Progressive Disease (PD) During the Induction Phase

Percentage of participants with CR + VGPR + PR (ORR), CR, VGPR, PR, SD, PD according to IMWG criteria. CR=negative immunofixation of serum and urine; disappearance of soft tissue plasmacytomas;<5% PC in bone marrow. VGPR=serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% reduction in serum M-component plus urine M-component <100 mg/24 hour. PR=50% reduction of serum M-protein and reduction in 24 hour urine M-protein by 90% or <200 mg/24 hour or decrease 50% difference between involved FLC levels or 50% reduction in bone marrow plasma cells if baseline percentage was 30%; and if present at Baseline, 50% reduction in the size of soft tissue plasmacytomas. SD=not meeting criteria for VGPR, PR or PD. PD=25% increase in lowest value any of the following: serum M-component, urine M-component, difference between involved and uninvolved FLC levels, bone marrow PC percentage; new or increase in size of existing bone lesions or soft tissue plasmacytomas. (NCT02046070)
Timeframe: Day 1 of Cycles 1-13, 28-day cycles (Up to 1 year)

Percentage of Participants With CR + VGR + PR (ORR), CR, VGPR, and PR in NDMM Participants Remaining on Treatment After 13 Cycles

Percentage of participants with Overall Response (CR + VGPR + PR), CR, VGPR and PR according to IMWG criteria. CR=negative immunofixation of serum and urine; disappearance of soft tissue plasmacytomas;<5% PC in bone marrow. VGPR=serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% reduction in serum M-component plus urine M-component <100 mg/24 hour. PR=50% reduction of serum M-protein and reduction in 24 hour urine M-protein by 90% or <200 mg/24 hour or decrease 50% difference between involved FLC levels or 50% reduction in bone marrow plasma cells if baseline percentage was 30%; and if present at Baseline, 50% reduction in the size of soft tissue plasmacytomas. (NCT02046070)
Timeframe: Day 1 of each 28-day Cycle (Up to 45 months)

Tmax: Time to First Occurrence of Cmax for Ixazomib in NDMM Participants

(NCT02046070)
Timeframe: Cycle 1 Days 1 and 15 predose and at multiple timepoints (up to 168 hours) postdose

Tmax: Time to First Occurrence of Cmax for Ixazomib in RRMM Participants

(NCT02046070)
Timeframe: Cycle 1 Days 1 and 15 predose and at multiple timepoints (up to 168) hours postdose

AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for Ixazomib

(NCT01645930)
Timeframe: Cycle 1, Day 1 pre-dose and multiple time-points (up to 168 hours) post-dose

AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for Ixazomib

(NCT01645930)
Timeframe: Cycle 1, Day 15 pre-dose and multiple time-points (up to 336 hours) post-dose

Cmax: Maximum Observed Plasma Concentration for Ixazomib

(NCT01645930)
Timeframe: Cycle 1, Day 1 pre-dose and multiple time-points (up to 168 hours) post-dose

Cmax: Maximum Observed Plasma Concentration for Ixazomib

(NCT01645930)
Timeframe: Cycle 1, Day 15 pre-dose and multiple time-points (up to 336 hours) post-dose

Duration of Response (DOR)

DOR was defined as the length of time between the date of first documented response (PR, VGPR, or CR) and the date of first documented progressive disease (PD). According to IMWG criteria: CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in bone marrow; PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour. (NCT01645930)
Timeframe: From date of documentation of a confirmed response to date of progressive disease, (approximately 20 months)

Number of Participants With Dose Limiting Toxicities (DLTs)

DLT was defined as any of the following AEs that were considered by investigator to be possibly related to therapy: 1. Grade 4 neutropenia lasting at least 7 consecutive days; 2. Grade 3 neutropenia with fever and/or infection; 3. Grade 4 thrombocytopenia at least 7 consecutive days; 4. Grade 3 thrombocytopenia with clinically significant bleeding; 5. Platelet count <10,000/mm^3; 6. Grade 2 peripheral neuropathy with pain or ≥Grade 3 peripheral neuropathy; 7. Grade 3 or greater nausea and / or emesis despite the use of optimal anti-emetic prophylaxis; 8. Grade 3 or greater diarrhea that occurred despite maximal supportive therapy; 9. Any other Grade 3 or greater nonhematologic toxicity with the following exceptions: Grade 3 arthralgia/myalgia, <1 week Grade 3 fatigue; 10. A delay of >2 weeks in the subsequent cycle of treatment; 11. Other combination study drug-related nonhematologic toxicities ≥Grade 2 that, in the opinion of the investigator, required discontinuation of study drug. (NCT01645930)
Timeframe: Cycle 1 (up to Day 28)

Percentage of Participants With Confirmed Best Response Category

Percentage of participants who achieve or maintain any best response category during the treatment period were reported. Best response includes complete response (CR), very good partial response (VGPR), and partial response (PR). Response was assessed according to IMWG criteria. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in bone marrow; PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour. (NCT01645930)
Timeframe: From Cycle 1, Day 1 to Cycle 3, Day 1 until disease progression (approximately 20 months)

Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib

(NCT01645930)
Timeframe: Cycle 1, Day 1 pre-dose and multiple time-points (up to 168 hours) post-dose

Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib

(NCT01645930)
Timeframe: Cycle 1, Day 15 pre-dose and multiple time-points (up to 336 hours) post-dose

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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 SAE is defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or was a medically important event. (NCT01645930)
Timeframe: From the first dose of study drug through 30 days after the last dose of study drug (up to 577 days)

Number of Participants With Clinically Significant Laboratory Abnormalities Reported as Adverse Events of ≥Grade 3 Intensity

Clinically significant laboratory abnormalities were defined as any test results which were observed beyond the clinically acceptable limits as per the discretion of investigator. Clinical laboratory tests included chemistry, hematology and urinalysis tests. (NCT01645930)
Timeframe: From the first dose of study drug through 30 days after the last dose of study drug (up to 577 days)

Number of Participants With Clinically Significant Vital Signs Reported as Adverse Events

The number of participants who meet markedly abnormal criteria for vital signs, included diastolic and systolic blood pressure, heart rate, oral temperature, respiratory rate, and body weight. (NCT01645930)
Timeframe: From the first dose of study drug through 30 days after the last dose of study drug (up to 577 days)

Reviews

13 reviews available for glycine and Recrudescence

Trials

14 trials available for glycine and Recrudescence

Other Studies

23 other studies available for glycine and Recrudescence