Trial Outcomes & Findings for S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary Amyloidosis (NCT NCT03499808)
NCT ID: NCT03499808
Last Updated: 2025-09-09
Results Overview
To assess the efficacy as measured by the confirmed overall hematologic response rate (partial response, very good partial response, complete response) of isatuximab in relapsed/ refractory systemic light chain (AL) amyloidosis. Measured as rate of partial response or better. Partial response is defined as a dFLC decrease of ≥ 50%, but remaining \> 4.0 mg/dL. Very good partial response is defined as the difference between involved and uninvolved FLCs \[dFLC\] \< 4.0 mg/dL. Complete response is defined as laboratory values within the normal range free light chain (FLC) ratio (0.25 - 1.65) and negative serum and urine immunofixation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
From date of enrollment until progression or death due to any cause, whichever occurs first, assessed up to 4 years
Results posted on
2025-09-09
Participant Flow
43 participants were enrolled of which 35 were eligible and analyzable.
Participant milestones
| Measure |
Treatment (Isatuximab)
Patients receive isatuximab IV on days 1, 8, 15, and 22 of course 1 and on days 1 and 15 of subsequent courses. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity.
Isatuximab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary Amyloidosis
Baseline characteristics by cohort
| Measure |
Treatment (Isatuximab)
n=35 Participants
Patients receive isatuximab IV on days 1, 8, 15, and 22 of course 1 and on days 1 and 15 of subsequent courses. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity.
Isatuximab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Age, Continuous
|
70 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Performance Status
PS 0
|
8 Participants
n=5 Participants
|
|
Performance Status
PS 1
|
25 Participants
n=5 Participants
|
|
Performance Status
PS 2
|
2 Participants
n=5 Participants
|
|
Involved Light Chain
Kappa
|
10 Participants
n=5 Participants
|
|
Involved Light Chain
Lambda
|
23 Participants
n=5 Participants
|
|
Involved Light Chain
None
|
1 Participants
n=5 Participants
|
|
Involved Light Chain
Unknown
|
1 Participants
n=5 Participants
|
|
IgG (mg/dL)
|
700 mg/dL
n=5 Participants
|
|
Organ Involvement
Single Organ Involvement
|
18 Participants
n=5 Participants
|
|
Organ Involvement
Multiple Organ involvement
|
17 Participants
n=5 Participants
|
|
Mayo Cardiac Biomarker Stage
Stage I
|
7 Participants
n=5 Participants
|
|
Mayo Cardiac Biomarker Stage
Stage II
|
8 Participants
n=5 Participants
|
|
Mayo Cardiac Biomarker Stage
Stage III
|
8 Participants
n=5 Participants
|
|
Mayo Cardiac Biomarker Stage
Stage IV
|
1 Participants
n=5 Participants
|
|
Mayo Cardiac Biomarker Stage
Unknown
|
1 Participants
n=5 Participants
|
|
Mayo Cardiac Biomarker Stage
Not assessed - no cardiac involvement at baseline
|
10 Participants
n=5 Participants
|
|
Plasma Cells (%, Bone Marrow)
|
6 % of Bone Marrow
n=5 Participants
|
|
Kidney Involvement
Yes
|
14 Participants
n=5 Participants
|
|
Kidney Involvement
No
|
21 Participants
n=5 Participants
|
|
Nervous System Involvement
Yes
|
9 Participants
n=5 Participants
|
|
Nervous System Involvement
No
|
26 Participants
n=5 Participants
|
|
Liver Involvement
Yes
|
1 Participants
n=5 Participants
|
|
Liver Involvement
No
|
34 Participants
n=5 Participants
|
|
Soft Tissue Involvement
Yes
|
5 Participants
n=5 Participants
|
|
Soft Tissue Involvement
No
|
30 Participants
n=5 Participants
|
|
GI Tract Involvement
Yes
|
2 Participants
n=5 Participants
|
|
GI Tract Involvement
No
|
33 Participants
n=5 Participants
|
|
Cardiac Involvement
Yes
|
25 Participants
n=5 Participants
|
|
Cardiac Involvement
No
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of enrollment until progression or death due to any cause, whichever occurs first, assessed up to 4 yearsPopulation: 35 participants who received treatment and are analyzable.
To assess the efficacy as measured by the confirmed overall hematologic response rate (partial response, very good partial response, complete response) of isatuximab in relapsed/ refractory systemic light chain (AL) amyloidosis. Measured as rate of partial response or better. Partial response is defined as a dFLC decrease of ≥ 50%, but remaining \> 4.0 mg/dL. Very good partial response is defined as the difference between involved and uninvolved FLCs \[dFLC\] \< 4.0 mg/dL. Complete response is defined as laboratory values within the normal range free light chain (FLC) ratio (0.25 - 1.65) and negative serum and urine immunofixation.
Outcome measures
| Measure |
Isatuximab
n=35 Participants
Patients receive isatuximab intravenously (IV) on days 1, 8, 15, and 22 of course 1 and on days 1 and 15 of subsequent courses. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Assess Efficacy by Confirmed Overall Hematologic Response
|
77.1 percentage of paticipants
Interval 59.9 to 89.6
|
SECONDARY outcome
Timeframe: From date of enrollment until progression or death due to any cause, whichever occurs first, assessed up to 4 yearsPopulation: Participants who completed at least one day of treatment.
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Outcome measures
| Measure |
Isatuximab
n=35 Participants
Patients receive isatuximab intravenously (IV) on days 1, 8, 15, and 22 of course 1 and on days 1 and 15 of subsequent courses. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
To Evaluate Toxicities in the Treatment of Relapsed/Refractory AL Amyloidosis With Isatuximab.
Atrial fibrillation
|
1 Participants
|
|
To Evaluate Toxicities in the Treatment of Relapsed/Refractory AL Amyloidosis With Isatuximab.
Fatigue
|
1 Participants
|
|
To Evaluate Toxicities in the Treatment of Relapsed/Refractory AL Amyloidosis With Isatuximab.
Infections and infestations - Other, specify
|
1 Participants
|
|
To Evaluate Toxicities in the Treatment of Relapsed/Refractory AL Amyloidosis With Isatuximab.
Infusion related reaction
|
1 Participants
|
|
To Evaluate Toxicities in the Treatment of Relapsed/Refractory AL Amyloidosis With Isatuximab.
Lung infection
|
2 Participants
|
|
To Evaluate Toxicities in the Treatment of Relapsed/Refractory AL Amyloidosis With Isatuximab.
Lymphocyte count decreased
|
3 Participants
|
|
To Evaluate Toxicities in the Treatment of Relapsed/Refractory AL Amyloidosis With Isatuximab.
Pancreatitis
|
1 Participants
|
|
To Evaluate Toxicities in the Treatment of Relapsed/Refractory AL Amyloidosis With Isatuximab.
Pruritus
|
1 Participants
|
|
To Evaluate Toxicities in the Treatment of Relapsed/Refractory AL Amyloidosis With Isatuximab.
Skin infection
|
1 Participants
|
|
To Evaluate Toxicities in the Treatment of Relapsed/Refractory AL Amyloidosis With Isatuximab.
Syncope
|
1 Participants
|
SECONDARY outcome
Timeframe: From date of enrollment up to 2 yearsPopulation: 35 eligible participants who received at least one dose of study drug.
Overall survival is measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. While OS was assessed up to 4 years, 4 year estimates were not reached. We are reporting the 24 month estimate (how many participants reached survival time of at least 24 months).
Outcome measures
| Measure |
Isatuximab
n=35 Participants
Patients receive isatuximab intravenously (IV) on days 1, 8, 15, and 22 of course 1 and on days 1 and 15 of subsequent courses. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival (24 Month Estimate)
|
85 percent of participants
Interval 73.0 to 97.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: 27 participants with response to study treatment
Duration of response is measure as time between hematologic response and hematologic progression. Hematologic progression is defined as 50% increase from nadir. While duration of response was assessed up to 4 years, 4 year estimates were not reached. We are reporting the 24 month estimate (how many participants achieved 24 month duration of response)
Outcome measures
| Measure |
Isatuximab
n=27 Participants
Patients receive isatuximab intravenously (IV) on days 1, 8, 15, and 22 of course 1 and on days 1 and 15 of subsequent courses. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Duration of Response (24 Month Estimate)
|
81 Percent of Participants
Interval 67.0 to 96.0
|
SECONDARY outcome
Timeframe: From registration to time of confirmed hematologic progressionPopulation: Of the 35 analyzable participants, 27 achieved a response.
To evaluate time to hematologic response. Partial response is defined as a dFLC decrease of ≥ 50%, but remaining \> 4.0 mg/dL. Very good partial response is defined as the difference between involved and uninvolved FLCs \[dFLC\] \< 4.0 mg/dL. Complete response is defined as laboratory values within the normal range free light chain (FLC) ratio (0.25 - 1.65) and negative serum and urine immunofixation.
Outcome measures
| Measure |
Isatuximab
n=27 Participants
Patients receive isatuximab intravenously (IV) on days 1, 8, 15, and 22 of course 1 and on days 1 and 15 of subsequent courses. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Time to Hematologic Response
|
1.1 Months
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: From registration to time of confirmed hematologic progressionPopulation: 35 participants were analyzable
To evaluate progression-free survival (24 month estimate) Hematologic progression is defined as 50% increase from nadir, or from baseline (if there was no response) in any ONE OR MORE of the following: 1. Serum M-protein: 50% increase in Serum M protein to a value greater than 0.5 g/dL. 2. Urine M protein: 50% increase in Urine M protein to a value greater than 200 mg/day (a visible peak must be present) 3. Free light chain increase of 50% to a value greater than 10 mg/dL
Outcome measures
| Measure |
Isatuximab
n=35 Participants
Patients receive isatuximab intravenously (IV) on days 1, 8, 15, and 22 of course 1 and on days 1 and 15 of subsequent courses. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Progression-free Survival (24 Month Estimate)
|
74 percentage of paticipants
Interval 59.0 to 88.0
|
Adverse Events
Isatuximab
Serious events: 15 serious events
Other events: 32 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Isatuximab
n=35 participants at risk
Patients receive isatuximab intravenously (IV) on days 1, 8, 15, and 22 of course 1 and on days 1 and 15 of subsequent courses. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
2.9%
1/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Cardiac disorders
Atrioventricular block complete
|
2.9%
1/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Cardiac disorders
Heart failure
|
2.9%
1/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Gastrointestinal disorders
Abdominal pain
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Gastrointestinal disorders
Diarrhea
|
2.9%
1/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Gastrointestinal disorders
Gastrointestinal disorders-Other
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Gastrointestinal disorders
Nausea
|
2.9%
1/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
General disorders
Death NOS
|
2.9%
1/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
General disorders
Edema limbs
|
2.9%
1/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
General disorders
Fever
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Infections and infestations
Bronchial infection
|
2.9%
1/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Infections and infestations
Enterocolitis infectious
|
2.9%
1/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Infections and infestations
Infections and infestations-Other
|
2.9%
1/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Infections and infestations
Lung infection
|
8.6%
3/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Infections and infestations
Skin infection
|
2.9%
1/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Injury, poisoning and procedural complications
Hip fracture
|
2.9%
1/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
1/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.6%
3/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.9%
1/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.9%
1/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Nervous system disorders
Syncope
|
2.9%
1/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
Other adverse events
| Measure |
Isatuximab
n=35 participants at risk
Patients receive isatuximab intravenously (IV) on days 1, 8, 15, and 22 of course 1 and on days 1 and 15 of subsequent courses. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
28.6%
10/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders-Other
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Cardiac disorders
Cardiac disorders-Other
|
8.6%
3/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Cardiac disorders
Heart failure
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Cardiac disorders
Palpitations
|
11.4%
4/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Cardiac disorders
Sinus tachycardia
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Ear and labyrinth disorders
Ear pain
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Endocrine disorders
Hypothyroidism
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Eye disorders
Blurred vision
|
8.6%
3/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Eye disorders
Cataract
|
8.6%
3/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Eye disorders
Dry eye
|
8.6%
3/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Eye disorders
Eye disorders-Other
|
17.1%
6/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
5/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Gastrointestinal disorders
Constipation
|
25.7%
9/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Gastrointestinal disorders
Diarrhea
|
51.4%
18/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Gastrointestinal disorders
Dry mouth
|
8.6%
3/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Gastrointestinal disorders
Dyspepsia
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Gastrointestinal disorders
Dysphagia
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Gastrointestinal disorders
Gastrointestinal disorders-Other
|
11.4%
4/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Gastrointestinal disorders
Mucositis oral
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Gastrointestinal disorders
Nausea
|
25.7%
9/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Gastrointestinal disorders
Vomiting
|
17.1%
6/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
General disorders
Chills
|
11.4%
4/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
General disorders
Edema limbs
|
22.9%
8/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
General disorders
Fatigue
|
28.6%
10/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
General disorders
Fever
|
17.1%
6/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
General disorders
Gait disturbance
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
General disorders
General disorders and administration site conditio
|
8.6%
3/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
General disorders
Non-cardiac chest pain
|
8.6%
3/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
General disorders
Pain
|
14.3%
5/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Infections and infestations
Infections and infestations-Other
|
17.1%
6/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Infections and infestations
Lung infection
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Infections and infestations
Sinusitis
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Infections and infestations
Skin infection
|
8.6%
3/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Infections and infestations
Upper respiratory infection
|
45.7%
16/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Infections and infestations
Urinary tract infection
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Injury, poisoning and procedural complications
Bruising
|
17.1%
6/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Injury, poisoning and procedural complications
Fall
|
8.6%
3/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
42.9%
15/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications-Oth
|
8.6%
3/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Investigations
Alanine aminotransferase increased
|
8.6%
3/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Investigations
Alkaline phosphatase increased
|
22.9%
8/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Investigations
Aspartate aminotransferase increased
|
22.9%
8/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Investigations
Blood bilirubin increased
|
11.4%
4/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Investigations
Cardiac troponin I increased
|
14.3%
5/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Investigations
Cardiac troponin T increased
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Investigations
Creatinine increased
|
17.1%
6/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Investigations
INR increased
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Investigations
Investigations-Other
|
14.3%
5/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Investigations
Lymphocyte count decreased
|
28.6%
10/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Investigations
Weight gain
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Investigations
Weight loss
|
8.6%
3/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Metabolism and nutrition disorders
Anorexia
|
22.9%
8/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.7%
9/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
17.1%
6/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
17.1%
6/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
7/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
17.1%
6/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
11.4%
4/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.7%
9/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.7%
9/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
7/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
17.1%
6/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder -
|
11.4%
4/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.1%
6/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
17.1%
6/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl
|
14.3%
5/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Nervous system disorders
Dizziness
|
22.9%
8/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Nervous system disorders
Dysgeusia
|
8.6%
3/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Nervous system disorders
Headache
|
22.9%
8/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Nervous system disorders
Neuralgia
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
17.1%
6/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Psychiatric disorders
Confusion
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Psychiatric disorders
Depression
|
8.6%
3/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Psychiatric disorders
Insomnia
|
20.0%
7/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Renal and urinary disorders
Chronic kidney disease
|
11.4%
4/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Renal and urinary disorders
Proteinuria
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Reproductive system and breast disorders
Gynecomastia
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.7%
9/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
7/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
17.1%
6/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.6%
3/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
17.1%
6/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders-Ot
|
8.6%
3/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
11.4%
4/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.4%
4/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders-Other
|
22.9%
8/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Vascular disorders
Hot flashes
|
5.7%
2/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Vascular disorders
Hypertension
|
17.1%
6/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
|
Vascular disorders
Hypotension
|
8.6%
3/35 • Up to 4 years after registration
Participants who received protocol treatment and are eligible are included
|
Additional Information
Adam Rosenthal
SWOG Statistics and Data Management Center
Phone: 206-652-9711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60