Percentage of Participants With Toxicities Post-randomization by Toxicity Type
Allogeneic Hematopoietic Stem Cell Transplantation With Ixazomib for High Risk Multiple Myeloma (BMT CTN 1302) · Source last updated 2023-01-04
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
2 years post-randomization
What was measured
Toxicities are graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0. Higher grades correspond to worse symptoms with the minimum grade being a 0 and the maximum grade being a 5. Toxicities post-randomization are described for each treatment arm by the type of toxicity as well as peak overall grade.
Analysis population: All randomized participants are included in the analysis.
Groups in this outcome
Ixazomib Maintenance
Allogeneic HSCT and Fludarabine/Melphalan/Bortezomib conditioning followed by Ixazomib maintenance
Allogeneic HSCT: Eligible patients with a Human Leukocyte Antigen (HLA)-matched related or unrelated donor will undergo allogeneic hematopoietic stem cell transplant at Day 0. For GVHD prophylaxis, patients will be given Tacrolimus from Day -3 until at least 6 months following initiation, at an intravenous daily dose of 0.015 mg/kg. This will be combined with an intravenous administration of Methotrexate at 5 mg/m2 on Days +1, +3, +6, and +11.
Fludarabine: Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3.
Melphalan: Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3.
Bortezomib: Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3.
Ixazomib: Between 60 and 120 days following HSCT, patients randomized to the experimental arm will receive Ixazomib maintenance. Maintenance will begin at 3-mg oral doses on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule, following successful completion of 3 cycles at the previous dosage, for a total of 12 cycles.
Placebo
Allogeneic HSCT and Fludarabine/Melphalan/Bortezomib conditioning followed by placebo maintenance.
Allogeneic HSCT: Eligible patients with a Human Leukocyte Antigen (HLA)-matched related or unrelated donor will undergo allogeneic hematopoietic stem cell transplant at Day 0. For GVHD prophylaxis, patients will be given Tacrolimus from Day -3 until at least 6 months following initiation, at an intravenous daily dose of 0.015 mg/kg. This will be combined with an intravenous administration of Methotrexate at 5 mg/m2 on Days +1, +3, +6, and +11.
Fludarabine: Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3.
Melphalan: Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3.
Bortezomib: Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3.
Placebo: Between 60 and 120 days following HSCT, patients randomized to the control group will be given 3 mg of placebo orally on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule following successful completion of 3 cycles of placebo maintenance at the 3-mg dose. This will continue for a total of 12 cycles.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Ixazomib Maintenance
21
Placebo
22
Reported measurements
Maximum Toxicity Grade : 0 - 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
8
Not reported
Not reported
Not reported
Not reported
Placebo
6
Not reported
Not reported
Not reported
Not reported
Maximum Toxicity Grade : 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
13
Not reported
Not reported
Not reported
Not reported
Placebo
14
Not reported
Not reported
Not reported
Not reported
Maximum Toxicity Grade : 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
0
Not reported
Not reported
Not reported
Not reported
Placebo
1
Not reported
Not reported
Not reported
Not reported
Maximum Toxicity Grade : 5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
0
Not reported
Not reported
Not reported
Not reported
Placebo
1
Not reported
Not reported
Not reported
Not reported
Abnormal Liver Symptoms
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
3
Not reported
Not reported
Not reported
Not reported
Placebo
2
Not reported
Not reported
Not reported
Not reported
Dysgeusia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
1
Not reported
Not reported
Not reported
Not reported
Placebo
2
Not reported
Not reported
Not reported
Not reported
Encephalopathy
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
0
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Grade 3-5 Allergic Reaction
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
0
Not reported
Not reported
Not reported
Not reported
Placebo
1
Not reported
Not reported
Not reported
Not reported
Grade 3-5 Anaphylaxis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
0
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Grade 3-5 Blood/Lymphatic Toxicity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
5
Not reported
Not reported
Not reported
Not reported
Placebo
8
Not reported
Not reported
Not reported
Not reported
Grade 3-5 Cardiac Toxicity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
6
Not reported
Not reported
Not reported
Not reported
Placebo
7
Not reported
Not reported
Not reported
Not reported
Grade 3-5 Fatigue
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
3
Not reported
Not reported
Not reported
Not reported
Placebo
3
Not reported
Not reported
Not reported
Not reported
Grade 3-5 Fever
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
0
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Grade 3-5 GI Toxicity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
6
Not reported
Not reported
Not reported
Not reported
Placebo
7
Not reported
Not reported
Not reported
Not reported
Grade 3-5 Hearing Loss
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
0
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Grade 3-5 Hemorrhage
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
0
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Grade 3-5 Hepatobiliary/Pancreas
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
1
Not reported
Not reported
Not reported
Not reported
Placebo
7
Not reported
Not reported
Not reported
Not reported
Grade 3-5 Hyperthyroidism
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
0
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Grade 3-5 Hypothyroidism
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
0
Not reported
Not reported
Not reported
Not reported
Placebo
1
Not reported
Not reported
Not reported
Not reported
Grade 3-5 Metabolic Toxicity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
4
Not reported
Not reported
Not reported
Not reported
Placebo
6
Not reported
Not reported
Not reported
Not reported
Grade 3-5 Musculoskeletal Toxicity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
1
Not reported
Not reported
Not reported
Not reported
Placebo
3
Not reported
Not reported
Not reported
Not reported
Grade 3-5 Nervous System Toxicity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
4
Not reported
Not reported
Not reported
Not reported
Placebo
4
Not reported
Not reported
Not reported
Not reported
Grade 3-5 Ocular Toxicity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
0
Not reported
Not reported
Not reported
Not reported
Placebo
2
Not reported
Not reported
Not reported
Not reported
Grade 3-5 Renal Toxicity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
0
Not reported
Not reported
Not reported
Not reported
Placebo
5
Not reported
Not reported
Not reported
Not reported
Grade 3-5 Respiratory Toxicity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
2
Not reported
Not reported
Not reported
Not reported
Placebo
8
Not reported
Not reported
Not reported
Not reported
Grade 3-5 Skin/Subcutaneous Tissue Toxicity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
1
Not reported
Not reported
Not reported
Not reported
Placebo
5
Not reported
Not reported
Not reported
Not reported
Grade 3-5 Vascular Toxicity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
2
Not reported
Not reported
Not reported
Not reported
Placebo
3
Not reported
Not reported
Not reported
Not reported
Hepatitis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
0
Not reported
Not reported
Not reported
Not reported
Placebo
1
Not reported
Not reported
Not reported
Not reported
Intestinal Obstruction
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Liver Failure
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
0
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Severe Muscle Weakness/Paralysis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
0
Not reported
Not reported
Not reported
Not reported
Placebo
1
Not reported
Not reported
Not reported
Not reported
Sudden Vision Loss
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
0
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Tumor Lysis Syndrome
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ixazomib Maintenance
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
6
title
Maximum Toxicity Grade : 0 - 2
categories
measurements
group Id
OG000
value
13
group Id
OG001
value
14
title
Maximum Toxicity Grade : 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Maximum Toxicity Grade : 4
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Maximum Toxicity Grade : 5
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
2
title
Abnormal Liver Symptoms
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
2
title
Dysgeusia
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Encephalopathy
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Grade 3-5 Allergic Reaction
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Grade 3-5 Anaphylaxis
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
8
title
Grade 3-5 Blood/Lymphatic Toxicity
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
7
title
Grade 3-5 Cardiac Toxicity
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
3
title
Grade 3-5 Fatigue
denoms
counts
group Id
OG000
value
21
group Id
OG001
value
22
units
Participants
description
Toxicities are graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0. Higher grades correspond to worse symptoms with the minimum grade being a 0 and the maximum grade being a 5. Toxicities post-randomization are described for each treatment arm by the type of toxicity as well as peak overall grade.
groups
description
Allogeneic HSCT and Fludarabine/Melphalan/Bortezomib conditioning followed by Ixazomib maintenance
Allogeneic HSCT: Eligible patients with a Human Leukocyte Antigen (HLA)-matched related or unrelated donor will undergo allogeneic hematopoietic stem cell transplant at Day 0. For GVHD prophylaxis, patients will be given Tacrolimus from Day -3 until at least 6 months following initiation, at an intravenous daily dose of 0.015 mg/kg. This will be combined with an intravenous administration of Methotrexate at 5 mg/m2 on Days +1, +3, +6, and +11.
Fludarabine: Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3.
Melphalan: Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3.
Bortezomib: Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3.
Ixazomib: Between 60 and 120 days following HSCT, patients randomized to the experimental arm will receive Ixazomib maintenance. Maintenance will begin at 3-mg oral doses on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule, following successful completion of 3 cycles at the previous dosage, for a total of 12 cycles.
id
OG000
title
Ixazomib Maintenance
description
Allogeneic HSCT and Fludarabine/Melphalan/Bortezomib conditioning followed by placebo maintenance.
Allogeneic HSCT: Eligible patients with a Human Leukocyte Antigen (HLA)-matched related or unrelated donor will undergo allogeneic hematopoietic stem cell transplant at Day 0. For GVHD prophylaxis, patients will be given Tacrolimus from Day -3 until at least 6 months following initiation, at an intravenous daily dose of 0.015 mg/kg. This will be combined with an intravenous administration of Methotrexate at 5 mg/m2 on Days +1, +3, +6, and +11.
Fludarabine: Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3.
Melphalan: Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3.
Bortezomib: Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3.
Placebo: Between 60 and 120 days following HSCT, patients randomized to the control group will be given 3 mg of placebo orally on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule following successful completion of 3 cycles of placebo maintenance at the 3-mg dose. This will continue for a total of 12 cycles.
id
OG001
title
Placebo
param Type
COUNT_OF_PARTICIPANTS
population Description
All randomized participants are included in the analysis.
reporting Status
POSTED
time Frame
2 years post-randomization
title
Percentage of Participants With Toxicities Post-randomization by Toxicity Type
Triangle