Trial Outcomes & Findings for Lenalidomide With or Without Ixazomib Citrate and Dexamethasone in Treating Patients With Residual Multiple Myeloma After Donor Stem Cell Transplant (NCT NCT02389517)
NCT ID: NCT02389517
Last Updated: 2026-01-22
Results Overview
Rate of MRD negativity after 12 months of treatment with Ixazomib in combination with lenalidomide and dexamethasone compared to MRD negativity rate after 12 months of lenalidomide alone. For the majority of patients, where MRD positivity at screening will be determined by Multi-parameter Flow Cytometry (MFC), an improvement will be defined as a conversion from MRD-positive to MRD-negative disease by MFC. Additionally, in the fraction of patients with MRD-negative disease by MFC at screening, who were MRD-positive by Next Generation Sequencing (NGS), an improvement will be defined as a conversion from MRD-positive to MRD-negative disease by NGS
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
At 12 months
Results posted on
2026-01-22
Participant Flow
Participant milestones
| Measure |
Arm I (Ixazomib Citrate, Lenalidomide, Dexamethasone)
Patients receive ixazomib citrate PO on days 1, 8, and 15, lenalidomide PO QD on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22 (of courses 1-4 only).
Ixazomib Citrate: Given PO
Lenalidomide: Given PO
Dexamethasone: Given PO
|
Arm II (Lenalidomide)
Patients receive lenalidomide PO as in Arm I.
Lenalidomide: Given PO
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
22
|
|
Overall Study
COMPLETED
|
14
|
17
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
Arm I (Ixazomib Citrate, Lenalidomide, Dexamethasone)
Patients receive ixazomib citrate PO on days 1, 8, and 15, lenalidomide PO QD on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22 (of courses 1-4 only).
Ixazomib Citrate: Given PO
Lenalidomide: Given PO
Dexamethasone: Given PO
|
Arm II (Lenalidomide)
Patients receive lenalidomide PO as in Arm I.
Lenalidomide: Given PO
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Progressive disease
|
0
|
1
|
Baseline Characteristics
Lenalidomide With or Without Ixazomib Citrate and Dexamethasone in Treating Patients With Residual Multiple Myeloma After Donor Stem Cell Transplant
Baseline characteristics by cohort
| Measure |
Arm I (Ixazomib Citrate, Lenalidomide, Dexamethasone)
n=20 Participants
Patients receive ixazomib citrate PO on days 1, 8, and 15, lenalidomide PO QD on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22 (of courses 1-4 only).
Ixazomib Citrate: Given PO
Lenalidomide: Given PO
Dexamethasone: Given PO
|
Arm II (Lenalidomide)
n=22 Participants
Patients receive lenalidomide PO as in Arm I.
Lenalidomide: Given PO
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Age, Continuous
|
62.6 years
n=270 Participants
|
59.1 years
n=4 Participants
|
60.8 years
n=9 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=270 Participants
|
9 Participants
n=4 Participants
|
17 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=270 Participants
|
13 Participants
n=4 Participants
|
25 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=270 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=270 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=270 Participants
|
16 Participants
n=4 Participants
|
30 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=270 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: At 12 monthsPopulation: The data for 3 patients in Arm 1 AND 4 patients in Arm II were not collected.
Rate of MRD negativity after 12 months of treatment with Ixazomib in combination with lenalidomide and dexamethasone compared to MRD negativity rate after 12 months of lenalidomide alone. For the majority of patients, where MRD positivity at screening will be determined by Multi-parameter Flow Cytometry (MFC), an improvement will be defined as a conversion from MRD-positive to MRD-negative disease by MFC. Additionally, in the fraction of patients with MRD-negative disease by MFC at screening, who were MRD-positive by Next Generation Sequencing (NGS), an improvement will be defined as a conversion from MRD-positive to MRD-negative disease by NGS
Outcome measures
| Measure |
Arm II (Lenalidomide)
n=13 Participants
Patients receive lenalidomide PO as in Arm I.
Lenalidomide: Given PO
|
Arm I (Ixazomib Citrate, Lenalidomide, Dexamethasone)
n=11 Participants
Patients receive ixazomib citrate PO on days 1, 8, and 15, lenalidomide PO QD on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22 (of courses 1-4 only).
Ixazomib Citrate: Given PO
Lenalidomide: Given PO
Dexamethasone: Given PO
|
|---|---|---|
|
Percentage of Participants With MRD Negativity
|
31 percentage of participants
|
18 percentage of participants
|
SECONDARY outcome
Timeframe: At 6 monthsOverall response was defined according to IMWG criteria as 1. very good partial response (VGPR) 2. complete response (CR) 3. stringent complete response (sCR)
Outcome measures
| Measure |
Arm II (Lenalidomide)
n=17 Participants
Patients receive lenalidomide PO as in Arm I.
Lenalidomide: Given PO
|
Arm I (Ixazomib Citrate, Lenalidomide, Dexamethasone)
n=14 Participants
Patients receive ixazomib citrate PO on days 1, 8, and 15, lenalidomide PO QD on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22 (of courses 1-4 only).
Ixazomib Citrate: Given PO
Lenalidomide: Given PO
Dexamethasone: Given PO
|
|---|---|---|
|
Overall Response (Number of Participants With VGPR, CR, sCR)
VGPR
|
3 Participants
|
5 Participants
|
|
Overall Response (Number of Participants With VGPR, CR, sCR)
CR
|
6 Participants
|
5 Participants
|
|
Overall Response (Number of Participants With VGPR, CR, sCR)
sCR
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: every 28 days, up to 2 yearsPopulation: Patients who had MRD-negative were analyzed.
Duraion of MRD-negativie disease was defined as the duration from the date of MRD negative to the date of diseae progression or date of last clinical follow up.
Outcome measures
| Measure |
Arm II (Lenalidomide)
n=4 Participants
Patients receive lenalidomide PO as in Arm I.
Lenalidomide: Given PO
|
Arm I (Ixazomib Citrate, Lenalidomide, Dexamethasone)
n=2 Participants
Patients receive ixazomib citrate PO on days 1, 8, and 15, lenalidomide PO QD on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22 (of courses 1-4 only).
Ixazomib Citrate: Given PO
Lenalidomide: Given PO
Dexamethasone: Given PO
|
|---|---|---|
|
Duration of MRD-negative Disease
|
1.98 years
Interval 1.82 to 2.0
|
1.91 years
Interval 1.84 to 1.98
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: One patient in Arm1 and two patients in Arm 2 were not analyzed because their data were not collected.
Time to event will be estimated using the product-limit method of Kaplan and Meier.
Outcome measures
| Measure |
Arm II (Lenalidomide)
n=20 Participants
Patients receive lenalidomide PO as in Arm I.
Lenalidomide: Given PO
|
Arm I (Ixazomib Citrate, Lenalidomide, Dexamethasone)
n=19 Participants
Patients receive ixazomib citrate PO on days 1, 8, and 15, lenalidomide PO QD on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22 (of courses 1-4 only).
Ixazomib Citrate: Given PO
Lenalidomide: Given PO
Dexamethasone: Given PO
|
|---|---|---|
|
Progression Free Survival
|
NA years
Insufficient number of participants with events to calculate via KM methodology
|
NA years
Interval 2.2 to
Insufficient number of participants with events to calculate via KM methodology
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: One patients in Arm 1 and two patients in Arm 2 were not analyzed because their data were not collected.
OS is the time from randomization date to death date. Participants who have not died will be censored on the last date they are known to be alive.
Outcome measures
| Measure |
Arm II (Lenalidomide)
n=20 Participants
Patients receive lenalidomide PO as in Arm I.
Lenalidomide: Given PO
|
Arm I (Ixazomib Citrate, Lenalidomide, Dexamethasone)
n=19 Participants
Patients receive ixazomib citrate PO on days 1, 8, and 15, lenalidomide PO QD on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22 (of courses 1-4 only).
Ixazomib Citrate: Given PO
Lenalidomide: Given PO
Dexamethasone: Given PO
|
|---|---|---|
|
Overall Survival
|
NA years
Median and 95% Confidence Interval could not be calculated due to an insufficient number of participants with events
|
NA years
Median and 95% Confidence Interval could not be calculated due to an insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to 30 days post-treatment, **up to 2 years**Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Outcome measures
| Measure |
Arm II (Lenalidomide)
n=22 Participants
Patients receive lenalidomide PO as in Arm I.
Lenalidomide: Given PO
|
Arm I (Ixazomib Citrate, Lenalidomide, Dexamethasone)
n=20 Participants
Patients receive ixazomib citrate PO on days 1, 8, and 15, lenalidomide PO QD on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22 (of courses 1-4 only).
Ixazomib Citrate: Given PO
Lenalidomide: Given PO
Dexamethasone: Given PO
|
|---|---|---|
|
Number of Patients With Adverse Events
skin hyperpigmentation
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Small intestine infection
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Sore throat
|
1 Participants
|
3 Participants
|
|
Number of Patients With Adverse Events
Spasticity
|
0 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events
Syncope
|
1 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Tinnitus
|
1 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events
Tooth infection
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Toothache
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Tremor
|
0 Participants
|
4 Participants
|
|
Number of Patients With Adverse Events
Upper respiratory infection
|
6 Participants
|
7 Participants
|
|
Number of Patients With Adverse Events
Urinary frequency
|
0 Participants
|
3 Participants
|
|
Number of Patients With Adverse Events
Urinary incontinence
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Urinary retention
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Urinary tract infection
|
0 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events
Vaginal discharge
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Vascular disorders - Other, specify
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Vomiting
|
1 Participants
|
6 Participants
|
|
Number of Patients With Adverse Events
Weight gain
|
1 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events
Wheezing
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
White blood cell decreased
|
1 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Acute kidney injury
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Anal pain
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Bone pain
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Bronchial Infection
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Cardiac disorders - Other, specify
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
chest pain -cardiac
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Conjunctivitis
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Creatinine Increased
|
2 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Cystitis noninfective
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Dry skin
|
2 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
External ear inflammation
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Flank pain
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Gastroesophageal reflux disease
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Gastrointestinal disorders - Other, specify
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Gingival pain
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Hyperglycemia
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Hearing impaired
|
2 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Hemorrhoidal hemorrhage
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Hypocalcemia
|
3 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Hypophosphatemia
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Musculoskeletal and connective tissue disorder - Other, specify
|
3 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Neck pain
|
3 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Personality change
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Postnasal drip
|
2 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Pruritus
|
2 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Rash aceniform
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Respiratory, thoracic and mediastinal disorders - Other, specify
|
4 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Sinus tachycardia
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Sinusitis
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Somnolence
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Superficial thrombophlebitis
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Supraventricular tachycardia
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Thromboembolic event
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Vertigo
|
2 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Weight loss
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Cough
|
4 Participants
|
6 Participants
|
|
Number of Patients With Adverse Events
Dehydration
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Dry mouth
|
0 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events
Dysgeusia
|
1 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Dyspepsia
|
1 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Eye disorders - others
|
1 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events
Fall
|
1 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Fatigue
|
9 Participants
|
10 Participants
|
|
Number of Patients With Adverse Events
Flu like symptoms
|
5 Participants
|
4 Participants
|
|
Number of Patients With Adverse Events
Joint range of motion decreased cervical spine
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Lethargy
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Leukocytosis
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Libido decreased
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Localized edema
|
1 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Lung infection
|
3 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Lymphocyte count decreased
|
0 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events
Memory impariment
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Metabolism and nutrition disorders - Other, specify
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Mucosal infection
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Mucositis oral
|
0 Participants
|
3 Participants
|
|
Number of Patients With Adverse Events
Muscle weakness lower limb
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Muscle weakness upper limb
|
0 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events
Myalgia
|
4 Participants
|
4 Participants
|
|
Number of Patients With Adverse Events
Nasal congestion
|
3 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events
Nausea
|
4 Participants
|
10 Participants
|
|
Number of Patients With Adverse Events
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
1 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Neutrophil count decreased
|
5 Participants
|
7 Participants
|
|
Number of Patients With Adverse Events
non-cardiac chest pain
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Oral dysesthesia
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Oral pain
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Otitis externa
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Pain
|
5 Participants
|
4 Participants
|
|
Number of Patients With Adverse Events
Pain in extremity
|
2 Participants
|
5 Participants
|
|
Number of Patients With Adverse Events
Papulopustular rash
|
1 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events
Paresthesia
|
1 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Paronychia
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Peripheral motor neuropathy
|
1 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Peripheral sensory neuropathy
|
5 Participants
|
5 Participants
|
|
Number of Patients With Adverse Events
Platelet count decreased
|
2 Participants
|
7 Participants
|
|
Number of Patients With Adverse Events
Psychiatric disorders - Other, specify
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Rash maculo-papular
|
1 Participants
|
3 Participants
|
|
Number of Patients With Adverse Events
Renal and urinary disorders - Other, specify
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Sepsis
|
0 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events
Sinus bradycardia
|
1 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Skin and subcutaneous tissue disorders - Other, specify
|
2 Participants
|
4 Participants
|
|
Number of Patients With Adverse Events
Anemia
|
4 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Abdominal pain
|
1 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events
Agitation
|
0 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events
Alanine aminotransferase increased
|
2 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Allergic reaction
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Allergic rhinitis
|
1 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Anorexia
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Anxiety
|
0 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events
Arthraigia
|
3 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Aspartate aminotransferase increased
|
1 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Back Pain
|
5 Participants
|
5 Participants
|
|
Number of Patients With Adverse Events
Bloating
|
2 Participants
|
3 Participants
|
|
Number of Patients With Adverse Events
Blurred vision
|
1 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events
Bronchospasm
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Bruising
|
1 Participants
|
5 Participants
|
|
Number of Patients With Adverse Events
Buttock pain
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Chills
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Confusion
|
1 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events
Conspipation
|
5 Participants
|
7 Participants
|
|
Number of Patients With Adverse Events
Depression
|
1 Participants
|
4 Participants
|
|
Number of Patients With Adverse Events
Diarrhea
|
11 Participants
|
19 Participants
|
|
Number of Patients With Adverse Events
Dizziness
|
5 Participants
|
3 Participants
|
|
Number of Patients With Adverse Events
Dry eye
|
1 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Dyspnea
|
4 Participants
|
4 Participants
|
|
Number of Patients With Adverse Events
Ear pain
|
1 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Edema Limbs
|
3 Participants
|
6 Participants
|
|
Number of Patients With Adverse Events
Edema trunk
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Fever
|
3 Participants
|
3 Participants
|
|
Number of Patients With Adverse Events
Flushing
|
0 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events
Fracture
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Gait disturbance
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Generalized muscle weakness
|
0 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events
Gum infection
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Headache
|
1 Participants
|
3 Participants
|
|
Number of Patients With Adverse Events
Hypertension
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Hypokalemia
|
3 Participants
|
3 Participants
|
|
Number of Patients With Adverse Events
Hypomagnesemia
|
1 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Hyponatremia
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Hypotension
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Hypoxia
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Immune system disorders
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Infections and infestations
|
2 Participants
|
3 Participants
|
|
Number of Patients With Adverse Events
INR increased
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events
Insomnia
|
0 Participants
|
6 Participants
|
|
Number of Patients With Adverse Events
Irritability
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At 12 monthsOverall response was defined according to IMWG criteria as 1. very good partial response (VGPR) 2. complete response (CR) 3. stringent complete response (sCR)
Outcome measures
| Measure |
Arm II (Lenalidomide)
n=17 Participants
Patients receive lenalidomide PO as in Arm I.
Lenalidomide: Given PO
|
Arm I (Ixazomib Citrate, Lenalidomide, Dexamethasone)
n=14 Participants
Patients receive ixazomib citrate PO on days 1, 8, and 15, lenalidomide PO QD on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22 (of courses 1-4 only).
Ixazomib Citrate: Given PO
Lenalidomide: Given PO
Dexamethasone: Given PO
|
|---|---|---|
|
Overall Response (Number of Participants With VGPR, CR, sCR)
VGPR
|
6 Participants
|
3 Participants
|
|
Overall Response (Number of Participants With VGPR, CR, sCR)
CR
|
5 Participants
|
5 Participants
|
|
Overall Response (Number of Participants With VGPR, CR, sCR)
sCR
|
0 Participants
|
2 Participants
|
Adverse Events
Arm I (Ixazomib Citrate, Lenalidomide, Dexamethasone)
Serious events: 5 serious events
Other events: 20 other events
Deaths: 0 deaths
Arm II (Lenalidomide)
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Ixazomib Citrate, Lenalidomide, Dexamethasone)
n=20 participants at risk
Patients receive ixazomib citrate PO on days 1, 8, and 15, lenalidomide PO QD on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22 (of courses 1-4 only).
Ixazomib Citrate: Given PO
Lenalidomide: Given PO
Dexamethasone: Given PO
|
Arm II (Lenalidomide)
n=22 participants at risk
Patients receive lenalidomide PO as in Arm I.
Lenalidomide: Given PO
|
|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
General disorders
Fever
|
0.00%
0/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Injury, poisoning and procedural complications
Fracture
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Infections and infestations
Infections and infestations - others
|
10.0%
2/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Infections and infestations
Lung infection
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - others
|
0.00%
0/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders- others
|
0.00%
0/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Infections and infestations
Sepsis
|
10.0%
2/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Nervous system disorders
Syncope
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Infections and infestations
Upper respiratory infection
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
Other adverse events
| Measure |
Arm I (Ixazomib Citrate, Lenalidomide, Dexamethasone)
n=20 participants at risk
Patients receive ixazomib citrate PO on days 1, 8, and 15, lenalidomide PO QD on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22 (of courses 1-4 only).
Ixazomib Citrate: Given PO
Lenalidomide: Given PO
Dexamethasone: Given PO
|
Arm II (Lenalidomide)
n=22 participants at risk
Patients receive lenalidomide PO as in Arm I.
Lenalidomide: Given PO
|
|---|---|---|
|
Infections and infestations
Gum infection
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Nervous system disorders
Headache
|
15.0%
3/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
9.1%
2/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
13.6%
3/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Metabolism and nutrition disorders
Hypokalemia
|
15.0%
3/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
13.6%
3/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Vascular disorders
Hypotension
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Immune system disorders
Immune system disorders- others
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Infections and infestations
Infections and infestations-other
|
10.0%
2/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
9.1%
2/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Investigations
INR increased
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Psychiatric disorders
Insomnia
|
30.0%
6/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
General disorders
Irritability
|
10.0%
2/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased cervical spine
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Nervous system disorders
Lethargy
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Psychiatric disorders
Libido decreased
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
General disorders
Localized edema
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Infections and infestations
Lung infection
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
9.1%
2/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Investigations
Lymphocyte count decreased
|
10.0%
2/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Nervous system disorders
Memory impairment
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - other
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Infections and infestations
Mucosal infection
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Gastrointestinal disorders
Mucositis oral
|
15.0%
3/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
10.0%
2/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder-other
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
13.6%
3/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
4/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
18.2%
4/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
2/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
13.6%
3/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Gastrointestinal disorders
Nausea
|
50.0%
10/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
18.2%
4/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
13.6%
3/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - other
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Investigations
Neutrophil count decreased
|
35.0%
7/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
22.7%
5/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
General disorders
Non-cardiac chest pain
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Gastrointestinal disorders
Oral dysesthesia
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Gastrointestinal disorders
Oral pain
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Infections and infestations
Otitis externa
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
General disorders
Pain
|
20.0%
4/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
22.7%
5/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
5/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
9.1%
2/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Infections and infestations
Populopustular rash
|
10.0%
2/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Nervous system disorders
Paresthesia
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Infections and infestations
Paronychia
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.0%
5/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
22.7%
5/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Investigations
Platelet count decreased
|
35.0%
7/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
13.6%
3/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
9.1%
2/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Skin and subcutaneous tissue disorders
Pruitus
|
0.00%
0/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
9.1%
2/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Psychiatric disorders
Psychiatric disorders-other
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Renal and urinary disorders
Renal and urinary disorders-other
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders-other
|
0.00%
0/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
18.2%
4/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Cardiac disorders
Sinus bradycardia
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders-other
|
20.0%
4/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
9.1%
2/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Infections and infestations
Small intestine infection
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
15.0%
3/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Nervous system disorders
Spasticity
|
10.0%
2/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Ear and labyrinth disorders
Tinnitus
|
10.0%
2/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Infections and infestations
Tooth infection
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Gastrointestinal disorders
Toothache
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Nervous system disorders
Tremor
|
20.0%
4/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Infections and infestations
Upper respiratory infection
|
30.0%
6/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
27.3%
6/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Renal and urinary disorders
Urinary frequency
|
15.0%
3/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Renal and urinary disorders
Urinary incontinence
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Renal and urinary disorders
Urinary retention
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Infections and infestations
Urinary tract infection
|
10.0%
2/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Reproductive system and breast disorders
Vaginal discharge
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Vascular disorders
Vascular disorders-other
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Gastrointestinal disorders
Vertigo
|
0.00%
0/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
9.1%
2/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Investigations
Weight gain
|
10.0%
2/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Investigations
White blood cell decreased
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
13.6%
3/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Investigations
Aspartate aminotransferase increased
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
5/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
22.7%
5/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Gastrointestinal disorders
Bloating
|
15.0%
3/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
9.1%
2/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Eye disorders
Blurred vision
|
10.0%
2/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Injury, poisoning and procedural complications
Bruising
|
25.0%
5/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Cardiac disorders
Cardiac disorders - others
|
0.00%
0/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
General disorders
Chills
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Psychiatric disorders
Confusion
|
10.0%
2/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Eye disorders
Conjuinctivitis
|
0.00%
0/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Gastrointestinal disorders
Constipation
|
35.0%
7/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
22.7%
5/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.0%
6/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
18.2%
4/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Investigations
Creatinine increased
|
0.00%
0/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
9.1%
2/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Psychiatric disorders
Depression
|
20.0%
4/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Gastrointestinal disorders
Diarrhea
|
95.0%
19/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
50.0%
11/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Nervous system disorders
Dizziness
|
15.0%
3/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
22.7%
5/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Eye disorders
Dry eye
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
2/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
9.1%
2/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Nervous system disorders
Dysgeusia
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
4/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
18.2%
4/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Ear and labyrinth disorders
Ear pain
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
General disorders
Edema limbs
|
30.0%
6/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
13.6%
3/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
General disorders
Edema trunk
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Eye disorders
Eye disorders- others
|
10.0%
2/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
General disorders
Fatigue
|
50.0%
10/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
40.9%
9/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
General disorders
Fever
|
15.0%
3/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
13.6%
3/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
General disorders
Flu like symptoms
|
20.0%
4/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
22.7%
5/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Vascular disorders
Flushing
|
10.0%
2/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
General disorders
Gait disturbance
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.0%
2/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Gastrointestinal disorders
abdominal pain
|
10.0%
2/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Psychiatric disorders
Agitation
|
10.0%
2/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
9.1%
2/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Immune system disorders
Allergic reaction
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
4.5%
1/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
18.2%
4/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Metabolism and nutrition disorders
Anorexia
|
5.0%
1/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
|
Psychiatric disorders
Anxiety
|
10.0%
2/20 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
0.00%
0/22 • Up to 2 years after the end of treatment visit, ** up to 2.5 years**
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place