Trial Outcomes & Findings for Phase 2 Multi-center Study of Anti-PD-1 During Lymphopenic State After HDT/ASCT for Multiple Myeloma (NCT NCT02331368)

Last Updated: 2018-07-27

Results Overview

The primary efficacy endpoint is complete response rate. The complete response rate was estimated by the observed proportion of complete responders at day 180. Complete response (CR) was defined as negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow and negative bone marrow flow cytometry.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

32 participants

Primary outcome timeframe

180 days post-transplant

Results posted on

2018-07-27

Participant Flow

32 patients were enrolled and 3 withdrew consent prior to being treated.

Participant milestones

Participant milestones
Measure	Anti-PD-1 (MK-3475) Study Treatment: 200 mg/day of MK-3475 administered every 3 weeks, starting day +14 post-transplant for a total of 9 doses.
Overall Study STARTED	32
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Anti-PD-1 (MK-3475) Study Treatment: 200 mg/day of MK-3475 administered every 3 weeks, starting day +14 post-transplant for a total of 9 doses.
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Phase 2 Multi-center Study of Anti-PD-1 During Lymphopenic State After HDT/ASCT for Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anti-PD-1 (MK-3475) n=29 Participants Study Treatment: 200 mg/day of MK-3475 administered every 3 weeks, starting day +14 post-transplant for a total of 9 doses.
Age, Continuous	59 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 180 days post-transplant

Population: 32 patients were enrolled. 3 withdrew consent prior to treatment. Of the 29 treated, 26 were evaluable for response (subjects who received 2-9 doses of MK-3475 were evaluable). Of the 26, 23 completed end-of-treatment response evaluation.

Outcome measures

Outcome measures
Measure	Anti-PD-1 (MK-3475) n=23 Participants Study Treatment: 200 mg/day of MK-3475 administered every 3 weeks, starting day +14 post-transplant for a total of 9 doses.
The Number of Patients That Achieve Complete Response	7 Participants

SECONDARY outcome

Timeframe: 2 Years

Progression is defined as an increase of ≥ 25% from the lowest response value in any one or more of the following: Serum M-component with an absolute increase ≥ 0.5 g/dL; and/or Urine M-component with an absolute increase ≥ 200 mg/24 hours; and/or Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels (absolute increase must be \>100mg/l) Bone marrow plasma cell percentage (absolute % must be ≥10% Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas Development of hypercalcemia (corrected serum calcium \>11.5mg/100ml) that can be attributed solely to the plasma cell proliferative disorder

Outcome measures

Outcome measures
Measure	Anti-PD-1 (MK-3475) n=23 Participants Study Treatment: 200 mg/day of MK-3475 administered every 3 weeks, starting day +14 post-transplant for a total of 9 doses.
The Estimated Percentage of Patients Alive Without Relapse or Progression at 2 Years	83 percentage of patients Interval 68.0 to 100.0

SECONDARY outcome

Timeframe: 2 Years

Outcome measures

Outcome measures
Measure	Anti-PD-1 (MK-3475) n=23 Participants Study Treatment: 200 mg/day of MK-3475 administered every 3 weeks, starting day +14 post-transplant for a total of 9 doses.
The Estimated Percentage of Patients Alive at 2 Years	100 percentage of patients

Adverse Events

Anti-PD-1 (MK-3475)

Serious events: 14 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Anti-PD-1 (MK-3475) n=32 participants at risk Study Treatment: 200 mg/day of MK-3475 administered every 3 weeks, starting day +14 post-transplant for a total of 9 doses.
Blood and lymphatic system disorders Blood and Lymphatic Disorder, Other	12.5% 4/32 • Number of events 4 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
General disorders Infusion related reaction	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Hepatobiliary disorders Cholecystitis	6.2% 2/32 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Infections and infestations Infections and infestations - Other	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Infections and infestations Sepsis	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Infections and infestations Urinary tract infection	3.1% 1/32 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Injury, poisoning and procedural complications Fracture	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Nervous system disorders Radiculitis	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Nervous system disorders Syncope	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Renal and urinary disorders Acute kidney injury	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Respiratory, thoracic and mediastinal disorders Hypoxia	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Vascular disorders Thromboembolic event	9.4% 3/32 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.

Other adverse events

Other adverse events
Measure	Anti-PD-1 (MK-3475) n=32 participants at risk Study Treatment: 200 mg/day of MK-3475 administered every 3 weeks, starting day +14 post-transplant for a total of 9 doses.
Blood and lymphatic system disorders Anemia	56.2% 18/32 • Number of events 75 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Blood and lymphatic system disorders Febrile neutropenia	9.4% 3/32 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Cardiac disorders Chest pain - cardiac	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Cardiac disorders Sinus tachycardia	21.9% 7/32 • Number of events 10 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Ear and labyrinth disorders Vertigo	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Endocrine disorders Endocrine disorders - Other	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Endocrine disorders Hyperthyroidism	21.9% 7/32 • Number of events 8 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Endocrine disorders Hypothyroidism	15.6% 5/32 • Number of events 6 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Eye disorders Blurred vision	9.4% 3/32 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Eye disorders Cataract	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Eye disorders Eye disorders - Other	9.4% 3/32 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Gastrointestinal disorders Abdominal pain	15.6% 5/32 • Number of events 7 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Gastrointestinal disorders Constipation	28.1% 9/32 • Number of events 14 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Gastrointestinal disorders Diarrhea	75.0% 24/32 • Number of events 47 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Gastrointestinal disorders Dry mouth	15.6% 5/32 • Number of events 6 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Gastrointestinal disorders Dyspepsia	9.4% 3/32 • Number of events 6 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Gastrointestinal disorders Enterocolitis	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Gastrointestinal disorders Esophagitis	6.2% 2/32 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Gastrointestinal disorders Flatulence	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Gastrointestinal disorders Gastroesophageal reflux disease	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Gastrointestinal disorders Gastrointestinal disorders - Other	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Gastrointestinal disorders Gastrointestinal pain	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Gastrointestinal disorders Hemorrhoidal hemorrhage	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Gastrointestinal disorders Hemorrhoids	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Gastrointestinal disorders Lip pain	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Gastrointestinal disorders Mucositis oral	6.2% 2/32 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Gastrointestinal disorders Nausea	59.4% 19/32 • Number of events 26 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Gastrointestinal disorders Toothache	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Gastrointestinal disorders Vomiting	43.8% 14/32 • Number of events 17 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
General disorders Chills	6.2% 2/32 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
General disorders Edema limbs	9.4% 3/32 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
General disorders Fatigue	59.4% 19/32 • Number of events 28 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
General disorders Fever	34.4% 11/32 • Number of events 15 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
General disorders Flu like symptoms	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
General disorders Gait disturbance	3.1% 1/32 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
General disorders Infusion related reaction	12.5% 4/32 • Number of events 5 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
General disorders Irritability	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
General disorders Neck edema	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
General disorders Non-cardiac chest pain	9.4% 3/32 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
General disorders Pain	9.4% 3/32 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Immune system disorders Allergic reaction	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Immune system disorders Autoimmune disorder	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Infections and infestations Bladder infection	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Infections and infestations Bronchial infection	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Infections and infestations Infections and infestations - Other	6.2% 2/32 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Infections and infestations Mucosal infection	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Infections and infestations Otitis externa	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Infections and infestations Papulopustular rash	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Infections and infestations Sinusitis	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Infections and infestations Upper respiratory infection	25.0% 8/32 • Number of events 9 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Infections and infestations Urinary tract infection	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Injury, poisoning and procedural complications Bruising	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other	6.2% 2/32 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Investigations Activated partial thromboplastin time prolonged	6.2% 2/32 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Investigations Alanine aminotransferase increased	34.4% 11/32 • Number of events 18 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Investigations Alkaline phosphatase increased	6.2% 2/32 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Investigations Aspartate aminotransferase increased	25.0% 8/32 • Number of events 9 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Investigations Blood bilirubin increased	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Investigations Cholesterol high	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Investigations Creatinine increased	9.4% 3/32 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Investigations Investigations - Other	6.2% 2/32 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Investigations Lymphocyte count decreased	56.2% 18/32 • Number of events 111 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Investigations Lymphocyte count increased	6.2% 2/32 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Investigations Neutrophil count decreased	59.4% 19/32 • Number of events 76 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Investigations Platelet count decreased	59.4% 19/32 • Number of events 107 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Investigations Weight gain	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Investigations Weight loss	9.4% 3/32 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Investigations White blood cell decreased	53.1% 17/32 • Number of events 93 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Metabolism and nutrition disorders Anorexia	18.8% 6/32 • Number of events 6 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Metabolism and nutrition disorders Dehydration	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Metabolism and nutrition disorders Hypercalcemia	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Metabolism and nutrition disorders Hyperglycemia	28.1% 9/32 • Number of events 27 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Metabolism and nutrition disorders Hyperkalemia	9.4% 3/32 • Number of events 4 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Metabolism and nutrition disorders Hypernatremia	6.2% 2/32 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Metabolism and nutrition disorders Hyperuricemia	18.8% 6/32 • Number of events 8 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Metabolism and nutrition disorders Hypoalbuminemia	46.9% 15/32 • Number of events 27 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Metabolism and nutrition disorders Hypocalcemia	53.1% 17/32 • Number of events 55 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Metabolism and nutrition disorders Hypoglycemia	6.2% 2/32 • Number of events 6 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Metabolism and nutrition disorders Hypokalemia	34.4% 11/32 • Number of events 19 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Metabolism and nutrition disorders Hypomagnesemia	6.2% 2/32 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Metabolism and nutrition disorders Hyponatremia	25.0% 8/32 • Number of events 21 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Metabolism and nutrition disorders Hypophosphatemia	43.8% 14/32 • Number of events 25 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Musculoskeletal and connective tissue disorders Arthralgia	6.2% 2/32 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Musculoskeletal and connective tissue disorders Back pain	15.6% 5/32 • Number of events 7 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Musculoskeletal and connective tissue disorders Bone pain	6.2% 2/32 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Musculoskeletal and connective tissue disorders Flank pain	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Musculoskeletal and connective tissue disorders Myalgia	6.2% 2/32 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Musculoskeletal and connective tissue disorders Neck pain	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Musculoskeletal and connective tissue disorders Pain in extremity	15.6% 5/32 • Number of events 5 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Nervous system disorders Dizziness	18.8% 6/32 • Number of events 7 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Nervous system disorders Dysgeusia	6.2% 2/32 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Nervous system disorders Headache	25.0% 8/32 • Number of events 10 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Nervous system disorders Memory impairment	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Nervous system disorders Movements involuntary	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Nervous system disorders Paresthesia	9.4% 3/32 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Nervous system disorders Peripheral motor neuropathy	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Nervous system disorders Peripheral sensory neuropathy	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Nervous system disorders Presyncope	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Nervous system disorders Radiculitis	3.1% 1/32 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Nervous system disorders Sinus pain	6.2% 2/32 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Nervous system disorders Tremor	3.1% 1/32 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Psychiatric disorders Anxiety	9.4% 3/32 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Psychiatric disorders Confusion	3.1% 1/32 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Psychiatric disorders Depression	6.2% 2/32 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Psychiatric disorders Insomnia	15.6% 5/32 • Number of events 5 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Renal and urinary disorders Acute kidney injury	3.1% 1/32 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Renal and urinary disorders Cystitis noninfective	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Renal and urinary disorders Hematuria	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Renal and urinary disorders Proteinuria	9.4% 3/32 • Number of events 5 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Renal and urinary disorders Urinary frequency	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Renal and urinary disorders Urinary retention	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Renal and urinary disorders Urinary tract pain	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Reproductive system and breast disorders Genital edema	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Reproductive system and breast disorders Reproductive system and breast disorders - Other	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Reproductive system and breast disorders Vaginal pain	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Respiratory, thoracic and mediastinal disorders Atelectasis	6.2% 2/32 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Respiratory, thoracic and mediastinal disorders Cough	25.0% 8/32 • Number of events 9 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Respiratory, thoracic and mediastinal disorders Dyspnea	18.8% 6/32 • Number of events 8 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Respiratory, thoracic and mediastinal disorders Hiccups	6.2% 2/32 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	6.2% 2/32 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Respiratory, thoracic and mediastinal disorders Nasal congestion	12.5% 4/32 • Number of events 4 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Respiratory, thoracic and mediastinal disorders Postnasal drip	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Respiratory, thoracic and mediastinal disorders Productive cough	9.4% 3/32 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Respiratory, thoracic and mediastinal disorders Sore throat	15.6% 5/32 • Number of events 5 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Respiratory, thoracic and mediastinal disorders Wheezing	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Skin and subcutaneous tissue disorders Bullous dermatitis	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Skin and subcutaneous tissue disorders Dry skin	12.5% 4/32 • Number of events 4 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Skin and subcutaneous tissue disorders Pruritus	25.0% 8/32 • Number of events 10 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Skin and subcutaneous tissue disorders Rash acneiform	6.2% 2/32 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Skin and subcutaneous tissue disorders Rash maculo-papular	28.1% 9/32 • Number of events 10 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	6.2% 2/32 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Skin and subcutaneous tissue disorders Urticaria	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Surgical and medical procedures Surgical and medical procedures - Other	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Vascular disorders Flushing	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Vascular disorders Hot flashes	3.1% 1/32 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Vascular disorders Hypertension	31.2% 10/32 • Number of events 25 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Vascular disorders Hypotension	31.2% 10/32 • Number of events 15 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Vascular disorders Thromboembolic event	6.2% 2/32 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.

Additional Information

Dr. Attaphol Pawarode, M.D.

University of Michigan Comprehensive Cancer Center

Phone: 734-936-8785

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place