Trial Outcomes & Findings for Trial of Combination of Ixazomib and Lenalidomide and Dexamethasone in Smoldering Multiple Myeloma (NCT NCT02916771)

Last Updated: 2025-08-11

Results Overview

The proportion of patients who achieve progression free at 2 years will be compared to the rate published for the high risk SMM. By the Mayo Clinic model for risk factors, the median time to progression for patients with high risk SMM was only 1.9 years. Therefore, we assume that, a 2-years progression-free rate of 50% will not be considered promising and a true progression free rate of 75% or higher will be considered promising.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

61 participants

Primary outcome timeframe

2 years

Results posted on

2025-08-11

Participant Flow

Participant milestones

Participant milestones
Measure	Ixazomib * Cycles 1-9 * Ixazomib is administered orally on days 1, 8, 15 on a 28 days cycle * Lenalidomide is administered orally on days 1-21 on a 28 days cycle * Dexamethasone is administered orally on days 1, 8, 15, 22 on a 28 days cycle * Cycle 10-24 * Ixazomib is administered orally on days 1, 8, 15 on a 28 days cycle * Lenalidomide is administered orally on days 1-21 on a 28 days cycle * Supportive measures consistent with optimal patient care may be given throughout the study Ixazomib: Oral, proteasome inhibitor Lenalidomide: Oral, immunomodulatory agent Dexamethasone: Oral, steroid
Overall Study STARTED	61
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Ixazomib * Cycles 1-9 * Ixazomib is administered orally on days 1, 8, 15 on a 28 days cycle * Lenalidomide is administered orally on days 1-21 on a 28 days cycle * Dexamethasone is administered orally on days 1, 8, 15, 22 on a 28 days cycle * Cycle 10-24 * Ixazomib is administered orally on days 1, 8, 15 on a 28 days cycle * Lenalidomide is administered orally on days 1-21 on a 28 days cycle * Supportive measures consistent with optimal patient care may be given throughout the study Ixazomib: Oral, proteasome inhibitor Lenalidomide: Oral, immunomodulatory agent Dexamethasone: Oral, steroid
Overall Study Withdrawal by Subject	9
Overall Study Physician Decision	1
Overall Study Began treatment for another active malignancy	1

Baseline Characteristics

Trial of Combination of Ixazomib and Lenalidomide and Dexamethasone in Smoldering Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ixazomib n=55 Participants * Cycles 1-9 * Ixazomib is administered orally on days 1, 8, 15 on a 28 days cycle * Lenalidomide is administered orally on days 1-21 on a 28 days cycle * Dexamethasone is administered orally on days 1, 8, 15, 22 on a 28 days cycle * Cycle 10-24 * Ixazomib is administered orally on days 1, 8, 15 on a 28 days cycle * Lenalidomide is administered orally on days 1-21 on a 28 days cycle * Supportive measures consistent with optimal patient care may be given throughout the study Ixazomib: Oral, proteasome inhibitor Lenalidomide: Oral, immunomodulatory agent Dexamethasone: Oral, steroid
Age, Continuous	64 years n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	55 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Ixazomib n=55 Participants * Cycles 1-9 * Ixazomib is administered orally on days 1, 8, 15 on a 28 days cycle * Lenalidomide is administered orally on days 1-21 on a 28 days cycle * Dexamethasone is administered orally on days 1, 8, 15, 22 on a 28 days cycle * Cycle 10-24 * Ixazomib is administered orally on days 1, 8, 15 on a 28 days cycle * Lenalidomide is administered orally on days 1-21 on a 28 days cycle * Supportive measures consistent with optimal patient care may be given throughout the study Ixazomib: Oral, proteasome inhibitor Lenalidomide: Oral, immunomodulatory agent Dexamethasone: Oral, steroid
Proportion Of High Risk SMM Patients Who Are Progression Free 2 Years After Receiving IRD Combination Therapy	50 Participants

SECONDARY outcome

Timeframe: Time from protocol therapy initiation to the disease progression or death from any cause, censored at date last known progression free for those who have not progressed or died, or up to 60 months post initiation of therapy

Progression-free survival is defined as the time from protocol therapy initiation to the disease progression or death from any cause, censored at date last known progression free for those who have not progressed or died

Outcome measures

Outcome measures
Measure	Ixazomib n=53 Participants * Cycles 1-9 * Ixazomib is administered orally on days 1, 8, 15 on a 28 days cycle * Lenalidomide is administered orally on days 1-21 on a 28 days cycle * Dexamethasone is administered orally on days 1, 8, 15, 22 on a 28 days cycle * Cycle 10-24 * Ixazomib is administered orally on days 1, 8, 15 on a 28 days cycle * Lenalidomide is administered orally on days 1-21 on a 28 days cycle * Supportive measures consistent with optimal patient care may be given throughout the study Ixazomib: Oral, proteasome inhibitor Lenalidomide: Oral, immunomodulatory agent Dexamethasone: Oral, steroid
Progression Free Survival	52 Participants

SECONDARY outcome

Timeframe: The time from protocol therapy initiation until documented progression, censored at date last known progression-free for those who have not progressed or up to 60 months post initiation of therapy

Time to progression (TTP) is defined as the time from protocol therapy initiation until documented progression, censored at date last known progression-free for those who have not progressed.

Outcome measures

Outcome measures
Measure	Ixazomib n=55 Participants * Cycles 1-9 * Ixazomib is administered orally on days 1, 8, 15 on a 28 days cycle * Lenalidomide is administered orally on days 1-21 on a 28 days cycle * Dexamethasone is administered orally on days 1, 8, 15, 22 on a 28 days cycle * Cycle 10-24 * Ixazomib is administered orally on days 1, 8, 15 on a 28 days cycle * Lenalidomide is administered orally on days 1-21 on a 28 days cycle * Supportive measures consistent with optimal patient care may be given throughout the study Ixazomib: Oral, proteasome inhibitor Lenalidomide: Oral, immunomodulatory agent Dexamethasone: Oral, steroid
Time To Progression	49.9 months Interval 39.9 to Not reached

SECONDARY outcome

Timeframe: time from objective response to disease progression or death, or date last known progression-free and alive for those who have not progressed or died, or up to 60 months post initiation of therapy

Duration of response is defined as the time from objective response to disease progression or death, or date last known progression-free and alive for those who have not progressed or died

Outcome measures

Outcome measures
Measure	Ixazomib n=51 Participants * Cycles 1-9 * Ixazomib is administered orally on days 1, 8, 15 on a 28 days cycle * Lenalidomide is administered orally on days 1-21 on a 28 days cycle * Dexamethasone is administered orally on days 1, 8, 15, 22 on a 28 days cycle * Cycle 10-24 * Ixazomib is administered orally on days 1, 8, 15 on a 28 days cycle * Lenalidomide is administered orally on days 1-21 on a 28 days cycle * Supportive measures consistent with optimal patient care may be given throughout the study Ixazomib: Oral, proteasome inhibitor Lenalidomide: Oral, immunomodulatory agent Dexamethasone: Oral, steroid
Duration of Response	47.4 months Interval 37.0 to Not reached

SECONDARY outcome

Timeframe: 2 years

The objective response rate is defined as partial response or better according to the modified IMWG criteria.

Outcome measures

Outcome measures
Measure	Ixazomib n=55 Participants * Cycles 1-9 * Ixazomib is administered orally on days 1, 8, 15 on a 28 days cycle * Lenalidomide is administered orally on days 1-21 on a 28 days cycle * Dexamethasone is administered orally on days 1, 8, 15, 22 on a 28 days cycle * Cycle 10-24 * Ixazomib is administered orally on days 1, 8, 15 on a 28 days cycle * Lenalidomide is administered orally on days 1-21 on a 28 days cycle * Supportive measures consistent with optimal patient care may be given throughout the study Ixazomib: Oral, proteasome inhibitor Lenalidomide: Oral, immunomodulatory agent Dexamethasone: Oral, steroid
Objective Response Rate	51 Participants

SECONDARY outcome

Timeframe: Time from protocol therapy initiation to death or date last known alive, or up to 60 months post initiation of treatment

Overall survival is defined as the time from protocol therapy initiation to death or date last known alive

Outcome measures

Outcome measures
Measure	Ixazomib n=55 Participants * Cycles 1-9 * Ixazomib is administered orally on days 1, 8, 15 on a 28 days cycle * Lenalidomide is administered orally on days 1-21 on a 28 days cycle * Dexamethasone is administered orally on days 1, 8, 15, 22 on a 28 days cycle * Cycle 10-24 * Ixazomib is administered orally on days 1, 8, 15 on a 28 days cycle * Lenalidomide is administered orally on days 1-21 on a 28 days cycle * Supportive measures consistent with optimal patient care may be given throughout the study Ixazomib: Oral, proteasome inhibitor Lenalidomide: Oral, immunomodulatory agent Dexamethasone: Oral, steroid
Overall Survival	NA years Median overall survival was not reached at study completion.

Adverse Events

Ixazomib

Serious events: 15 serious events

Other events: 55 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Ixazomib n=55 participants at risk * Cycles 1-9 * Ixazomib is administered orally on days 1, 8, 15 on a 28 days cycle * Lenalidomide is administered orally on days 1-21 on a 28 days cycle * Dexamethasone is administered orally on days 1, 8, 15, 22 on a 28 days cycle * Cycle 10-24 * Ixazomib is administered orally on days 1, 8, 15 on a 28 days cycle * Lenalidomide is administered orally on days 1-21 on a 28 days cycle * Supportive measures consistent with optimal patient care may be given throughout the study Ixazomib: Oral, proteasome inhibitor Lenalidomide: Oral, immunomodulatory agent Dexamethasone: Oral, steroid
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, secondary malignancy	3.6% 2/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Infections and infestations Lung infection	3.6% 2/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Immune system disorders Allergic reaction	1.8% 1/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Metabolism and nutrition disorders Hyperglycemia	1.8% 1/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Metabolism and nutrition disorders Hyponatremia	1.8% 1/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Infections and infestations Skin infection	1.8% 1/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Metabolism and nutrition disorders Dehdyration	3.6% 2/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Vascular disorders Hypotension	3.6% 2/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Investigations Neutrophil count decreased	1.8% 1/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Investigations White blood cell decreased	1.8% 1/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Metabolism and nutrition disorders Acidosis	1.8% 1/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Cardiac disorders Sinus tachycardia	1.8% 1/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Investigations Platelet count decreased	1.8% 1/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders- Other	3.6% 2/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Nervous system disorders Syncope	1.8% 1/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Cardiac disorders Sinus bradycardia	1.8% 1/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Infections and infestations Upper respiratory infection	1.8% 1/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Nervous system disorders Cognitive disturbance	1.8% 1/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Infections and infestations Infections and infestations- Other	1.8% 1/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Nervous system disorders Intracranial hemorrhage	1.8% 1/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Gastrointestinal disorders Colitis	3.6% 2/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Psychiatric disorders Psychiatric disorders - Other	1.8% 1/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Psychiatric disorders Depression	1.8% 1/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Investigations Lymphocyte count decreased	3.6% 2/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Cardiac disorders Atrial fibrillation	1.8% 1/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.

Other adverse events

Other adverse events
Measure	Ixazomib n=55 participants at risk * Cycles 1-9 * Ixazomib is administered orally on days 1, 8, 15 on a 28 days cycle * Lenalidomide is administered orally on days 1-21 on a 28 days cycle * Dexamethasone is administered orally on days 1, 8, 15, 22 on a 28 days cycle * Cycle 10-24 * Ixazomib is administered orally on days 1, 8, 15 on a 28 days cycle * Lenalidomide is administered orally on days 1-21 on a 28 days cycle * Supportive measures consistent with optimal patient care may be given throughout the study Ixazomib: Oral, proteasome inhibitor Lenalidomide: Oral, immunomodulatory agent Dexamethasone: Oral, steroid
Investigations White blood cell decreased	80.0% 44/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Investigations Neutrophil count decreased	78.2% 43/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
General disorders Fatigue	74.5% 41/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	69.1% 38/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Gastrointestinal disorders Diarrhea	67.3% 37/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Blood and lymphatic system disorders Anemia	60.0% 33/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Gastrointestinal disorders Nausea	60.0% 33/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Investigations Platelet count decreased	60.0% 33/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
General disorders Edema limbs	56.4% 31/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Psychiatric disorders Insomnia	56.4% 31/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Nervous system disorders Peripheral sensory neuropathy	56.4% 31/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Musculoskeletal and connective tissue disorders Myalgia	49.1% 27/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Gastrointestinal disorders Constipation	47.3% 26/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Respiratory, thoracic and mediastinal disorders Cough	47.3% 26/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Nervous system disorders Dizziness	41.8% 23/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	38.2% 21/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Nervous system disorders Headache	34.5% 19/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Infections and infestations Upper respiratory infection	32.7% 18/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Gastrointestinal disorders Vomiting	32.7% 18/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Nervous system disorders Dysgeusia	29.1% 16/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Metabolism and nutrition disorders Hypophosphatemia	29.1% 16/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	27.3% 15/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Investigations Lymphocyte count decreased	27.3% 15/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Investigations Alanine aminotransferase increased	25.5% 14/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Musculoskeletal and connective tissue disorders Arthralgia	25.5% 14/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Eye disorders Blurred vision	25.5% 14/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Gastrointestinal disorders Dyspepsia	25.5% 14/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Metabolism and nutrition disorders Hypomagnesemia	23.6% 13/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Skin and subcutaneous tissue disorders Pruritus	23.6% 13/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Vascular disorders Flushing	21.8% 12/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Respiratory, thoracic and mediastinal disorders Sore throat	21.8% 12/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Injury, poisoning and procedural complications Bruising	20.0% 11/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Skin and subcutaneous tissue disorders Dry skin	20.0% 11/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
General disorders Fever	20.0% 11/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	20.0% 11/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Vascular disorders Hypertension	20.0% 11/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Nervous system disorders Tremor	20.0% 11/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Gastrointestinal disorders Bloating	18.2% 10/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Metabolism and nutrition disorders Hypokalemia	18.2% 10/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Investigations Aspartate aminotransferase increased	16.4% 9/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
General disorders Irritability	16.4% 9/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Nervous system disorders Cognitive disturbance	14.5% 8/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Cardiac disorders Sinus bradycardia	14.5% 8/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	14.5% 8/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Musculoskeletal and connective tissue disorders Back pain	12.7% 7/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Investigations Blood bilirubin increased	12.7% 7/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Gastrointestinal disorders Dry mouth	12.7% 7/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Metabolism and nutrition disorders Hypocalcemia	12.7% 7/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
General disorders Pain	12.7% 7/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	12.7% 7/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Vascular disorders Hot flashes	10.9% 6/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Metabolism and nutrition disorders Hyperglycemia	10.9% 6/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Nervous system disorders Concentration impairment	9.1% 5/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Metabolism and nutrition disorders Dehydration	9.1% 5/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
General disorders Flu like symptoms	9.1% 5/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Metabolism and nutrition disorders Hyponatremia	9.1% 5/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Vascular disorders Hypotension	9.1% 5/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
General disorders Localized edema	9.1% 5/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Respiratory, thoracic and mediastinal disorders Postnasal drip	9.1% 5/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Infections and infestations Urinary tract infection	9.1% 5/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Gastrointestinal disorders Abdominal pain	7.3% 4/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Psychiatric disorders Agitation	7.3% 4/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Metabolism and nutrition disorders Anorexia	7.3% 4/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Infections and infestations Bronchial infection	7.3% 4/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
General disorders Chills	7.3% 4/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Psychiatric disorders Depression	7.3% 4/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Eye disorders Dry eye	7.3% 4/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
General disorders Edema face	7.3% 4/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Eye disorders Eye disorders - Other	7.3% 4/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Gastrointestinal disorders Gastroesophageal reflux disease	7.3% 4/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Skin and subcutaneous tissue disorders Hyperhidrosis	7.3% 4/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Infections and infestations Lung infection	7.3% 4/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Nervous system disorders Memory impairment	7.3% 4/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Nervous system disorders Nervous system disorders - Other	7.3% 4/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Cardiac disorders Palpitations	7.3% 4/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Psychiatric disorders Restlessness	7.3% 4/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Infections and infestations Rhinitis inefective	7.3% 4/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Nervous system disorders Sinus pain	7.3% 4/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Skin and subcutaneous tissue disorders Skin atrophy	7.3% 4/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Investigations Weight loss	7.3% 4/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Cardiac disorders Atrial fibrilation	5.5% 3/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Ear and labyrinth disorders Ear pain	5.5% 3/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.5% 3/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Gastrointestinal disorders Gastrointestinal disorders - Other	5.5% 3/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Respiratory, thoracic and mediastinal disorders Hoarseness	5.5% 3/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Metabolism and nutrition disorders Hyperkalemia	5.5% 3/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Metabolism and nutrition disorders Hypernatremia	5.5% 3/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Nervous system disorders Presyncope	5.5% 3/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Renal and urinary disorders Renal and urinary disorders- Other	5.5% 3/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Infections and infestations Sinusitis	5.5% 3/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	5.5% 3/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Infections and infestations Skin infection	5.5% 3/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.
Respiratory, thoracic and mediastinal disorders Wheezing	5.5% 3/55 • Adverse Events were assessed from the time of signing informed consent, through 30 days after administration of the last dose of study drug (approximately 2 years). Deaths were assessed for up to 60 months post initiation of treatment.

Additional Information

Dr. Irene Ghobrial

Dana-Farber Cancer Institute

Phone: 617-632-4198

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place