Trial Outcomes & Findings for Low-Dose Azacitidine, Lenalidomide, and Low-Dose Dexamethasone in Relapsed or Refractory Multiple Myeloma (NCT NCT01155583)

NCT ID: NCT01155583

Last Updated: 2020-11-16

Results Overview

Azacitidine given at low but increasing doses up to 50mg/m2 twice a week. Maximum tolerated dose reported.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

45 participants

Primary outcome timeframe

During the first 28-day cycle

Results posted on

2020-11-16

Participant Flow

The 11 phase II participants were a separate population from phase I

Participant milestones

Participant milestones
Measure	Arm A (GFR>=60mL/Min) Dose Level DL 1 Azacitidine (AZA) 30mg/m2 1x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Azacitidine/Lenalidomide/Dexamethasone Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	Arm A (GFR>=60mL/Min) Dose Level 2 Azacitidine 40mg/m2 1x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	Arm A (GFR>=60mL/Min) Dose Level 3 Azacitidine 30mg/m2 2x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	Arm A (GFR>=60mL/Min) Dose Level 4 Azacitidine 40mg/m2 2x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	Arm A (GFR>=60mL/Min) Dose Level 5 Azacitidine 50mg/m2 2x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	Arm B (GFR 30-59mL/Min - CKD) Dose Level 1 Azacitidine 40mg/m2 2x week + Lenalidomide 10mg d1-21 every 28d + Dexamethasone 40mg once a week	Arm B (GFR 30-59mL/Min - CKD) Dose Level 2 Azacitidine 50mg/m2 2x week + Lenalidomide 10mg d1-21 every 28d + Dexamethasone 40mg once a week	Phase II Arm A or B GFR >= 30mL/Min Expansion Dose (50 BIW) Azacitidine 50mg/m2 2x week + Lenalidomide (10mg if CKD, 25mg if non-CKD) d1-21 every 28d + Dexamethasone 40mg once a week
Phase I STARTED	3	3	4	6	7	3	8	0
Phase I COMPLETED	3	3	4	6	6	3	5	0
Phase I NOT COMPLETED	0	0	0	0	1	0	3	0
Phase II - Expansion Phase STARTED	0	0	0	0	0	0	0	11
Phase II - Expansion Phase COMPLETED	0	0	0	0	0	0	0	11
Phase II - Expansion Phase NOT COMPLETED	0	0	0	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A (GFR>=60mL/Min) Dose Level DL 1 Azacitidine (AZA) 30mg/m2 1x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Azacitidine/Lenalidomide/Dexamethasone Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	Arm A (GFR>=60mL/Min) Dose Level 2 Azacitidine 40mg/m2 1x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	Arm A (GFR>=60mL/Min) Dose Level 3 Azacitidine 30mg/m2 2x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	Arm A (GFR>=60mL/Min) Dose Level 4 Azacitidine 40mg/m2 2x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	Arm A (GFR>=60mL/Min) Dose Level 5 Azacitidine 50mg/m2 2x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	Arm B (GFR 30-59mL/Min - CKD) Dose Level -1 Azacitidine 30mg/m2 2x week + Lenalidomide 10mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	Arm B (GFR 30-59mL/Min - CKD) Dose Level 1 Azacitidine 40mg/m2 2x week + Lenalidomide 10mg d1-21 every 28d + Dexamethasone 40mg once a week	Arm B (GFR 30-59mL/Min - CKD) Dose Level 2 Azacitidine 50mg/m2 2x week + Lenalidomide 10mg d1-21 every 28d + Dexamethasone 40mg once a week	Phase II Arm A or B GFR >= 30mL/Min Expansion Dose (50 BIW) Azacitidine 50mg/m2 2x week + Lenalidomide (10mg if CKD, 25mg if non-CKD) d1-21 every 28d + Dexamethasone 40mg once a week
Phase I Screen failure - did not start treatment	0	0	0	0	1	0	0	2	0
Phase I Withdrawal by Subject	0	0	0	0	0	0	0	1	0

Baseline Characteristics

Low-Dose Azacitidine, Lenalidomide, and Low-Dose Dexamethasone in Relapsed or Refractory Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A (GFR>=60mL/Min) Dose Level DL 1 n=3 Participants Azacitidine (AZA) 30mg/m2 1x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Azacitidine/Lenalidomide/Dexamethasone Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. lenalidomide: Given orally dexamethasone: Given orally DNA methylation analysis: Correlative studies gene expression analysis: Correlative studies bone marrow aspiration: Correlative studies immunohistochemistry staining method: Correlative studies reverse transcriptase-polymerase chain reaction: Correlative studies flow cytometry: Correlative studies	Arm A (GFR>=60mL/Min) Dose Level 2 n=3 Participants Azacitidine 40mg/m2 1x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity lenalidomide: Given orally dexamethasone: Given orally DNA methylation analysis: Correlative studies gene expression analysis: Correlative studies bone marrow aspiration: Correlative studies immunohistochemistry staining method: Correlative studies reverse transcriptase-polymerase chain reaction: Correlative studies flow cytometry: Correlative studies	Arm A (GFR>=60mL/Min) Dose Level 3 n=4 Participants Azacitidine 30mg/m2 2x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	Arm A (GFR>=60mL/Min) Dose Level 4 n=6 Participants Azacitidine 40mg/m2 2x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	Arm A (GFR>=60mL/Min) Dose Level 5 n=7 Participants Azacitidine 50mg/m2 2x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	Arm B (GFR 30-59mL/Min - CKD) Dose Level -1 Azacitidine 30mg/m2 2x week + Lenalidomide 10mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	Arm B (GFR 30-59mL/Min - CKD) Dose Level 1 n=3 Participants Azacitidine 40mg/m2 2x week + Lenalidomide 10mg d1-21 every 28d + Dexamethasone 40mg once a week	Arm B (GFR 30-59mL/Min - CKD) Dose Level 2 n=7 Participants Azacitidine 50mg/m2 2x week + Lenalidomide 10mg d1-21 every 28d + Dexamethasone 40mg once a week	Arm A or B GFR >= 30mL/ Min Expansion Dose (50 BIW) n=11 Participants Azacitidine 50mg/m2 2x week + Lenalidomide (10mg if CKD, 25mg if non-CKD) d1-21 every 28d + Dexamethasone 40mg once a week	Total n=44 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	3 Participants n=6 Participants	6 Participants n=6 Participants	23 Participants n=64 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	0 Participants n=10 Participants	3 Participants n=115 Participants	4 Participants n=6 Participants	5 Participants n=6 Participants	21 Participants n=64 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	5 Participants n=6 Participants	8 Participants n=6 Participants	25 Participants n=64 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants	2 Participants n=6 Participants	3 Participants n=6 Participants	19 Participants n=64 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants	7 Participants n=21 Participants	0 Participants n=10 Participants	3 Participants n=115 Participants	7 Participants n=6 Participants	11 Participants n=6 Participants	39 Participants n=64 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	5 Participants n=64 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	4 Participants n=64 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	5 Participants n=21 Participants	0 Participants n=10 Participants	3 Participants n=115 Participants	6 Participants n=6 Participants	11 Participants n=6 Participants	40 Participants n=64 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants	6 participants n=4 Participants	7 participants n=21 Participants	—	3 participants n=115 Participants	7 participants n=6 Participants	11 participants n=6 Participants	44 participants n=64 Participants

PRIMARY outcome

Timeframe: During the first 28-day cycle

Population: Participants in phase 1 portion of study

Azacitidine given at low but increasing doses up to 50mg/m2 twice a week. Maximum tolerated dose reported.

Outcome measures

Outcome measures
Measure	Arm A - Azacitidine/Lenalidomide/Dexamethasone n=23 Participants Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. azacitidine: Given SC lenalidomide: Given orally dexamethasone: Given orally DNA methylation analysis: Correlative studies gene expression analysis: Correlative studies bone marrow aspiration: Correlative studies immunohistochemistry staining method: Correlative studies reverse transcriptase-polymerase chain reaction: Correlative studies flow cytometry: Correlative studies	Arm B - CKD Azacitidine/Lenalidomide/Dexamethasone n=11 Participants Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. azacitidine: Given SC lenalidomide: Given orally dexamethasone: Given orally DNA methylation analysis: Correlative studies gene expression analysis: Correlative studies bone marrow aspiration: Correlative studies immunohistochemistry staining method: Correlative studies reverse transcriptase-polymerase chain reaction: Correlative studies flow cytometry: Correlative studies
Phase I: Highest Tolerated Low Dose (HTLD)	50 mg/m^2	50 mg/m^2

SECONDARY outcome

Timeframe: at 6 months

Population: Response-evaluable participants. Data from different dose levels were combined for the analysis as pre-specified in the study protocol

Percent of participants with response according to international response criteria (\>= PR) and percent of participants with clinical benefit response (\>= minor response according to adapted EBMT criteria). Determined with serum and 24 hour urine protein electrophoresis, and as appropriate, supplemented by immunofixation, serum free light chain assay, and bone marrow examination. Response before high dose melphalan and autologous stem cell transplant will also be confirmed by two separate blood and 24 hour urine tests between the last dose of combination therapy and the first dose of the mobilizing agent.

Outcome measures

Outcome measures
Measure	Arm A - Azacitidine/Lenalidomide/Dexamethasone n=41 Participants Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. azacitidine: Given SC lenalidomide: Given orally dexamethasone: Given orally DNA methylation analysis: Correlative studies gene expression analysis: Correlative studies bone marrow aspiration: Correlative studies immunohistochemistry staining method: Correlative studies reverse transcriptase-polymerase chain reaction: Correlative studies flow cytometry: Correlative studies	Arm B - CKD Azacitidine/Lenalidomide/Dexamethasone n=22 Participants Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. azacitidine: Given SC lenalidomide: Given orally dexamethasone: Given orally DNA methylation analysis: Correlative studies gene expression analysis: Correlative studies bone marrow aspiration: Correlative studies immunohistochemistry staining method: Correlative studies reverse transcriptase-polymerase chain reaction: Correlative studies flow cytometry: Correlative studies
Percent of Participants With Clinical Benefit and Response According to International Response Criteria international response criteria (>= PR)	20 percentage of participants	23 percentage of participants
Percent of Participants With Clinical Benefit and Response According to International Response Criteria clinical benefit response (>= minor response)	32 percentage of participants	32 percentage of participants

SECONDARY outcome

Timeframe: at 12 months

Population: Response-evaluable participants

Outcome measures

Outcome measures
Measure	Arm A - Azacitidine/Lenalidomide/Dexamethasone n=41 Participants Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. azacitidine: Given SC lenalidomide: Given orally dexamethasone: Given orally DNA methylation analysis: Correlative studies gene expression analysis: Correlative studies bone marrow aspiration: Correlative studies immunohistochemistry staining method: Correlative studies reverse transcriptase-polymerase chain reaction: Correlative studies flow cytometry: Correlative studies	Arm B - CKD Azacitidine/Lenalidomide/Dexamethasone n=22 Participants Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. azacitidine: Given SC lenalidomide: Given orally dexamethasone: Given orally DNA methylation analysis: Correlative studies gene expression analysis: Correlative studies bone marrow aspiration: Correlative studies immunohistochemistry staining method: Correlative studies reverse transcriptase-polymerase chain reaction: Correlative studies flow cytometry: Correlative studies
Percent of Participants With Clinical Benefit and Response According to International Response Criteria International response criteria (>= PR)	22 percentage of participants	23 percentage of participants
Percent of Participants With Clinical Benefit and Response According to International Response Criteria clinical benefit response (>= minor response)	32 percentage of participants	32 percentage of participants

SECONDARY outcome

Timeframe: Up to 3 years

Population: Evaluable participants who received treatment

Median PFS, measured in months from study entry to progression as defined by international response criteria or death of any cause, whichever comes first

Outcome measures

Outcome measures
Measure	Arm A - Azacitidine/Lenalidomide/Dexamethasone n=42 Participants Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. azacitidine: Given SC lenalidomide: Given orally dexamethasone: Given orally DNA methylation analysis: Correlative studies gene expression analysis: Correlative studies bone marrow aspiration: Correlative studies immunohistochemistry staining method: Correlative studies reverse transcriptase-polymerase chain reaction: Correlative studies flow cytometry: Correlative studies	Arm B - CKD Azacitidine/Lenalidomide/Dexamethasone Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. azacitidine: Given SC lenalidomide: Given orally dexamethasone: Given orally DNA methylation analysis: Correlative studies gene expression analysis: Correlative studies bone marrow aspiration: Correlative studies immunohistochemistry staining method: Correlative studies reverse transcriptase-polymerase chain reaction: Correlative studies flow cytometry: Correlative studies
Median Progression-free Survival (PFS)	3.1 months Interval 2.1 to 5.1	—

SECONDARY outcome

Timeframe: up to 3 years

Population: Evaluable participants who received treatment

Overall survival will be measured from study entry to death from any cause - median months survival will be reported

Outcome measures

Outcome measures
Measure	Arm A - Azacitidine/Lenalidomide/Dexamethasone n=42 Participants Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. azacitidine: Given SC lenalidomide: Given orally dexamethasone: Given orally DNA methylation analysis: Correlative studies gene expression analysis: Correlative studies bone marrow aspiration: Correlative studies immunohistochemistry staining method: Correlative studies reverse transcriptase-polymerase chain reaction: Correlative studies flow cytometry: Correlative studies	Arm B - CKD Azacitidine/Lenalidomide/Dexamethasone Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. azacitidine: Given SC lenalidomide: Given orally dexamethasone: Given orally DNA methylation analysis: Correlative studies gene expression analysis: Correlative studies bone marrow aspiration: Correlative studies immunohistochemistry staining method: Correlative studies reverse transcriptase-polymerase chain reaction: Correlative studies flow cytometry: Correlative studies
Overall Survival	18.6 months Interval 9.5 to 23.4	—

OTHER_PRE_SPECIFIED outcome

Timeframe: before and after the first cycle of therapy

Other events: 1 other events

Deaths: 3 deaths

Arm A (GFR>=60mL/ Min) Dose Level 3

Serious events: 2 serious events

Other events: 2 other events

Deaths: 4 deaths

Arm A (GFR>=60mL/ Min) Dose Level 4

Serious events: 2 serious events

Other events: 2 other events

Deaths: 5 deaths

Arm A (GFR>=60mL/ Min) Dose Level 5

Serious events: 1 serious events

Other events: 3 other events

Deaths: 6 deaths

Arm B (GFR 30-59mL/Min - CKD) Dose Level -1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm B (GFR 30-59mL/Min - CKD) Dose Level 1

Serious events: 1 serious events

Other events: 1 other events

Deaths: 3 deaths

Arm B (GFR 30-59mL/Min - CKD) Dose Level 2

Serious events: 1 serious events

Other events: 4 other events

Deaths: 5 deaths

Arm A or B GFR >= 30mL/ Min Expansion Dose (50 BIW)

Serious events: 1 serious events

Other events: 9 other events

Deaths: 10 deaths

Serious adverse events

Serious adverse events
Measure	Arm A (GFR>=60mL/Min) Dose Level DL 1 n=3 participants at risk Azacitidine (AZA) 30mg/m2 1x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Azacitidine/Lenalidomide/Dexamethasone Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	Arm A (GFR>=60mL/ Min) Dose Level 2 n=3 participants at risk Azacitidine 40mg/m2 1x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	Arm A (GFR>=60mL/ Min) Dose Level 3 n=4 participants at risk Azacitidine 30mg/m2 2x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	Arm A (GFR>=60mL/ Min) Dose Level 4 n=6 participants at risk Azacitidine 40mg/m2 2x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	Arm A (GFR>=60mL/ Min) Dose Level 5 n=6 participants at risk Azacitidine 50mg/m2 2x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	Arm B (GFR 30-59mL/Min - CKD) Dose Level -1 Azacitidine 30mg/m2 2x week + Lenalidomide 10mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	Arm B (GFR 30-59mL/Min - CKD) Dose Level 1 n=3 participants at risk Azacitidine 40mg/m2 2x week + Lenalidomide 10mg d1-21 every 28d + Dexamethasone 40mg once a week	Arm B (GFR 30-59mL/Min - CKD) Dose Level 2 n=6 participants at risk Azacitidine 50mg/m2 2x week + Lenalidomide 10mg d1-21 every 28d + Dexamethasone 40mg once a week	Arm A or B GFR >= 30mL/ Min Expansion Dose (50 BIW) n=11 participants at risk Azacitidine 50mg/m2 2x week + Lenalidomide (10mg if CKD, 25mg if non-CKD) d1-21 every 28d + Dexamethasone 40mg once a week
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	33.3% 2/6 • Number of events 2 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	16.7% 1/6 • Number of events 1 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	9.1% 1/11 • Number of events 1 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
Gastrointestinal disorders Esophagitis	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	16.7% 1/6 • Number of events 1 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/11 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
General disorders Pain	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	25.0% 1/4 • Number of events 1 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	33.3% 1/3 • Number of events 1 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/11 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
Infections and infestations Skin infection	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	16.7% 1/6 • Number of events 1 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/11 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
Infections and infestations Urinary tract infection	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	16.7% 1/6 • Number of events 1 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/11 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	33.3% 1/3 • Number of events 1 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/11 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	25.0% 1/4 • Number of events 2 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/11 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
Psychiatric disorders Confusion	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	33.3% 1/3 • Number of events 1 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/11 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	16.7% 1/6 • Number of events 1 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/11 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	25.0% 1/4 • Number of events 1 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/11 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	25.0% 1/4 • Number of events 1 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/11 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	25.0% 1/4 • Number of events 1 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/11 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.

Other adverse events

Other adverse events
Measure	Arm A (GFR>=60mL/Min) Dose Level DL 1 n=3 participants at risk Azacitidine (AZA) 30mg/m2 1x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Azacitidine/Lenalidomide/Dexamethasone Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	Arm A (GFR>=60mL/ Min) Dose Level 2 n=3 participants at risk Azacitidine 40mg/m2 1x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	Arm A (GFR>=60mL/ Min) Dose Level 3 n=4 participants at risk Azacitidine 30mg/m2 2x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	Arm A (GFR>=60mL/ Min) Dose Level 4 n=6 participants at risk Azacitidine 40mg/m2 2x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	Arm A (GFR>=60mL/ Min) Dose Level 5 n=6 participants at risk Azacitidine 50mg/m2 2x week + Lenalidomide 25mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	Arm B (GFR 30-59mL/Min - CKD) Dose Level -1 Azacitidine 30mg/m2 2x week + Lenalidomide 10mg d1-21 every 28d + Dexamethasone 40mg once a week Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.	Arm B (GFR 30-59mL/Min - CKD) Dose Level 1 n=3 participants at risk Azacitidine 40mg/m2 2x week + Lenalidomide 10mg d1-21 every 28d + Dexamethasone 40mg once a week	Arm B (GFR 30-59mL/Min - CKD) Dose Level 2 n=6 participants at risk Azacitidine 50mg/m2 2x week + Lenalidomide 10mg d1-21 every 28d + Dexamethasone 40mg once a week	Arm A or B GFR >= 30mL/ Min Expansion Dose (50 BIW) n=11 participants at risk Azacitidine 50mg/m2 2x week + Lenalidomide (10mg if CKD, 25mg if non-CKD) d1-21 every 28d + Dexamethasone 40mg once a week
General disorders Pain	33.3% 1/3 • Number of events 1 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	16.7% 1/6 • Number of events 2 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	9.1% 1/11 • Number of events 2 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
Blood and lymphatic system disorders Anemia	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	33.3% 1/3 • Number of events 1 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	16.7% 1/6 • Number of events 2 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	16.7% 1/6 • Number of events 4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	50.0% 3/6 • Number of events 17 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	27.3% 3/11 • Number of events 21 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
Gastrointestinal disorders Constipation	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	50.0% 3/6 • Number of events 4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	9.1% 1/11 • Number of events 2 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
Gastrointestinal disorders Diarrhea	33.3% 1/3 • Number of events 1 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	50.0% 3/6 • Number of events 8 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	18.2% 2/11 • Number of events 4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
General disorders Edema limbs	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	33.3% 2/6 • Number of events 3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/11 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
General disorders Fatigue	66.7% 2/3 • Number of events 2 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	16.7% 1/6 • Number of events 1 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	16.7% 1/6 • Number of events 1 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	66.7% 4/6 • Number of events 12 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	18.2% 2/11 • Number of events 13 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
General disorders Fever	33.3% 1/3 • Number of events 1 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	16.7% 1/6 • Number of events 1 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	9.1% 1/11 • Number of events 1 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
General disorders Injection site reaction	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	33.3% 2/6 • Number of events 2 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	18.2% 2/11 • Number of events 2 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	16.7% 1/6 • Number of events 1 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	9.1% 1/11 • Number of events 6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	33.3% 2/6 • Number of events 2 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	9.1% 1/11 • Number of events 2 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
Investigations Creatinine increased	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	50.0% 3/6 • Number of events 5 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	9.1% 1/11 • Number of events 1 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
Investigations Lymphocyte count decreased	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	25.0% 1/4 • Number of events 4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	50.0% 3/6 • Number of events 13 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	18.2% 2/11 • Number of events 28 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
Investigations Neutrophil count decreased	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	25.0% 1/4 • Number of events 6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	33.3% 2/6 • Number of events 8 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	33.3% 2/6 • Number of events 15 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	33.3% 1/3 • Number of events 1 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	66.7% 4/6 • Number of events 13 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	81.8% 9/11 • Number of events 29 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
Investigations Platelet count decreased	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	25.0% 1/4 • Number of events 4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	16.7% 1/6 • Number of events 3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	16.7% 1/6 • Number of events 1 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	18.2% 2/11 • Number of events 30 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
Investigations White blood cell decreased	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	16.7% 1/6 • Number of events 1 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	50.0% 3/6 • Number of events 22 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	18.2% 2/11 • Number of events 20 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
Metabolism and nutrition disorders Anorexia	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	50.0% 3/6 • Number of events 5 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	9.1% 1/11 • Number of events 4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	50.0% 3/6 • Number of events 9 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	18.2% 2/11 • Number of events 3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	33.3% 2/6 • Number of events 6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	9.1% 1/11 • Number of events 5 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	16.7% 1/6 • Number of events 1 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	18.2% 2/11 • Number of events 4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	16.7% 1/6 • Number of events 3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/11 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	25.0% 1/4 • Number of events 1 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	33.3% 2/6 • Number of events 10 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/11 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
Nervous system disorders Dizziness	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	50.0% 3/6 • Number of events 6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/11 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	33.3% 2/6 • Number of events 3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	18.2% 2/11 • Number of events 6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	25.0% 1/4 • Number of events 1 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	16.7% 1/6 • Number of events 1 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	9.1% 1/11 • Number of events 2 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	18.2% 2/11 • Number of events 4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
Skin and subcutaneous tissue disorders Itching scalp	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	50.0% 3/6 • Number of events 3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/11 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/4 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	— 0/0 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	0.00% 0/3 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	16.7% 1/6 • Number of events 1 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.	9.1% 1/11 • Number of events 6 • Up to 3 years from study entry Participants who started treatment on study were followed for Adverse Events. Number of participants at risk on Arm B Dose Level -1 is 0 because no participants were accrued to this dose level.

Additional Information

Dr. Jason Valent

Cleveland Clinic, Case Comprehensive Cancer Center

Phone: +1 216-445-7238

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place