Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of Pomalidomide Monotherapy in Subjects With Refractory or Relapsed Refractory Multiple Myeloma (NCT NCT01324947)

Last Updated: 2019-11-19

Results Overview

Objective response defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) based on Investigator Assessment. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level \<100 mg/24 hours; PR: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to \<200 mg/24 hours. A ≥50% decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria or a ≥50% reduction in plasma cells in place of M-protein if baseline was ≥30%. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

74 participants

Primary outcome timeframe

From randomization through the study follow-up phase; up to the data cut-off of 31 July 2014; Maximum time on follow-up was 141.1 weeks.

Results posted on

2019-11-19

Participant Flow

CC-4047-MM003C is a companion study for the trial CC-4047-MM-003 (NCT01311687). CC-4047-MM-003C enrolled those who discontinued treatment with dexamethasone alone (Treatment Arm B) in the CC-4047-MM-003 trial due to disease progression; those who had discontinued treatment with pomalidomide plus dexamethasone (Arm A) were not eligible to enroll

Participant milestones

Participant milestones
Measure	Pomalidomide Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
Overall Study STARTED	74
Overall Study Safety Population	73
Overall Study Efficacy Evaluable Population (EEP)	64
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	74

Reasons for withdrawal

Reasons for withdrawal
Measure	Pomalidomide Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
Overall Study Adverse Event	7
Overall Study Death	10
Overall Study Other	3
Overall Study Progressive Disease	50
Overall Study Withdrawal by Subject	3
Overall Study 1 discontinued before starting drug	1

Baseline Characteristics

Study to Evaluate the Safety and Efficacy of Pomalidomide Monotherapy in Subjects With Refractory or Relapsed Refractory Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pomalidomide n=74 Participants Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
Age, Continuous	64.9 years STANDARD_DEVIATION 9.25 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants
Race American Indian or Alaska Native	0 participants n=5 Participants
Race Asian	0 participants n=5 Participants
Race Black or African American	1 participants n=5 Participants
Race Native Hawaiian or Other Pacific Islanders	0 participants n=5 Participants
Race White	52 participants n=5 Participants
Race Other	2 participants n=5 Participants
Race Not Collected	19 participants n=5 Participants
Ethnicity Hispanic or Latino	6 participants n=5 Participants
Ethnicity Not Hispanic or Latino	49 participants n=5 Participants
Ethnicity Not Collected	19 participants n=5 Participants
Participants with Prior Anti-Myeloma (MM) Therapies	74 participants n=5 Participants
Durie-Salmon Multiple Myeloma Stage before Study Entry Stage I	8 participants n=5 Participants
Durie-Salmon Multiple Myeloma Stage before Study Entry Stage II	15 participants n=5 Participants
Durie-Salmon Multiple Myeloma Stage before Study Entry Stage III	50 participants n=5 Participants
Durie-Salmon Multiple Myeloma Stage before Study Entry Missing	1 participants n=5 Participants
Time From First Pathologic Diagnosis	7.6 years STANDARD_DEVIATION 3.72 • n=5 Participants

PRIMARY outcome

Timeframe: From randomization through the study follow-up phase; up to the data cut-off of 31 July 2014; Maximum time on follow-up was 141.1 weeks.

Population: Intent to Treat Population was defined as all enrolled participants.

Outcome measures

Outcome measures
Measure	Pomalidomide n=74 Participants Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
Percentage of Participants With an Objective Response According to International Myeloma Working Group (IMWG) Uniform Response Criteria Based on Investigator Assessment	23.0 percentage of participants

SECONDARY outcome

Timeframe: From randomization through the study follow-up phase; up to the data cut-off of 31 July 2014; Maximum time on follow-up was 141.1 weeks.

Population: Intent to treat population includes all participants enrolled.

Objective response defined as a best overall response of complete response (CR) or partial response (PR) based on the CR and requires all of the following: * Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days. * \<5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed. * No increase in size or number of lytic bone lesions. * Disappearance of soft tissue plasmacytomas. PR requires all of the following: * ≥50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days. * Reduction in 24-hour urinary light chain extraction by ≥90% or to \<200 mg, maintained at least 42 days. * For patients with non-secretory myeloma, ≥50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days.

Outcome measures

Outcome measures
Measure	Pomalidomide n=74 Participants Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
Percentage of Participants With Objective Response According to European Group for Blood and Marrow Transplantation (EBMT) Criteria Based on Investigator Assessment	20.3 percentage of participants

SECONDARY outcome

Timeframe: From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.

Population: Safety population includes all participants who received at least one dose of study drug.

An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE is any AE occurring at any dose that: * Results in death; * Is life-threatening; * Requires or prolongs existing inpatient hospitalization; * Results in persistent or significant disability/incapacity; * Is a congenital anomaly/birth defect; * Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required);-Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death

Outcome measures

Outcome measures
Measure	Pomalidomide n=73 Participants Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
Number of Participants With Adverse Events and Type of Adverse Events ≥1 SAE leading to stopping pomalidomide	6 participants
Number of Participants With Adverse Events and Type of Adverse Events ≥AE leading to discontinuation of pomalidomide	8 participants
Number of Participants With Adverse Events and Type of Adverse Events Any adverse event	73 participants
Number of Participants With Adverse Events and Type of Adverse Events Grade 3-4 adverse event	64 participants
Number of Participants With Adverse Events and Type of Adverse Events AE related to pomalidomide	51 participants
Number of Participants With Adverse Events and Type of Adverse Events Grade 3-4 AE related to pomalidomide	33 participants
Number of Participants With Adverse Events and Type of Adverse Events Grade 5 AE	19 participants
Number of Participants With Adverse Events and Type of Adverse Events ≥1 Serious AE (SAE)	52 participants
Number of Participants With Adverse Events and Type of Adverse Events ≥1 SAE related to pomalidomide	15 participants
Number of Participants With Adverse Events and Type of Adverse Events ≥1 study drug related AE leading to stopping POM	1 participants
Number of Participants With Adverse Events and Type of Adverse Events ≥1 AE leading to reduction of pomalidomide	11 participants
Number of Participants With Adverse Events and Type of Adverse Events ≥1 study drug related AE leading to reducing POM	9 participants
Number of Participants With Adverse Events and Type of Adverse Events ≥1 AE leading to interruption of pomalidomide	41 participants
Number of Participants With Adverse Events and Type of Adverse Events ≥ 1 study drug related interruption of POM	25 participants

SECONDARY outcome

Timeframe: From randomization through the follow-up phase; Maximum duration of follow-up for PFS was 90.3 weeks.

Population: Intent to Treat included all participants enrolled.

Progression-free survival was calculated as the time from randomization to disease progression as determined by the Investigator based on the International Myeloma Working Group Uniform Response criteria (IMWG), or death on study, whichever occurred earlier. Progressive disease requires 1 of the following: * Increase of ≥ 25% from nadir in: * Serum M-component (absolute increase ≥ 0.5 g/dl) * Urine M-component (absolute increase ≥ 200 mg/24 hours) * In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase \> 100 mg/dl) * Bone marrow plasma cell percentage (absolute % ≥ 10%) * Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas.

Outcome measures

Outcome measures
Measure	Pomalidomide n=74 Participants Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
Kaplan Meier Estimates for Progression Free Survival (PFS) by Investigator Based on IMWG	16.0 weeks Interval 11.6 to 19.7

SECONDARY outcome

Timeframe: From randomization through the follow-up phase; up to the data-cut off of 31 July 2014; Maximum time to progression follow-up was 90.3 weeks.

Population: Intent to Treat includes all participants enrolled

Time to progression (TTP) was calculated as the time from randomization to the first documented progression confirmed by the investigator and based on the International Myeloma Working Group Uniform Response criteria (IMWG). Progressive disease requires 1 of the following: * Increase of ≥ 25% from nadir in: * Serum M-component (absolute increase ≥ 0.5 g/dl) * Urine M-component (absolute increase ≥ 200 mg/24 hours) * In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase \> 100 mg/dl) * Bone marrow plasma cell percentage (absolute % ≥ 10%) * Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas. * Development of hypercalcemia (corrected serum calcium \> 11.5 mg/dl) attributed solely to plasma cell proliferative disease.

Outcome measures

Outcome measures
Measure	Pomalidomide n=74 Participants Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
Kaplan-Meier Estimate for Time to Progression (TTP) Based on Investigator Assessment Using IMWG Criteria	19.0 weeks Interval 14.1 to 27.4

SECONDARY outcome

Timeframe: From randomization through the study follow-up phase; up to the data cut-off of 31 July 2014; Maximum duration of response follow-up was 90.3 weeks.

Population: Includes those who had a partial response or better.

Duration of Response (calculated for responders only) is defined as the time from the initial documented response (partial response or better) to confirmed disease progression by the investigator based on IMWG criteria.

Outcome measures

Outcome measures
Measure	Pomalidomide n=17 Participants Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
Kaplan-Meier Estimate Duration of Response Based on Investigator Assessment Using IMWG Criteria	28.3 weeks Interval 8.1 to 53.4

SECONDARY outcome

Timeframe: From randomization through the follow-up phase; Maximum time on follow-up was 141.1 weeks.

Population: Intent to Treat population included all participants enrolled into the study

Overall survival was calculated as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.

Outcome measures

Outcome measures
Measure	Pomalidomide n=74 Participants Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
Kaplan-Meier Estimate for Overall Survival	33.6 weeks Interval 26.4 to 66.3

SECONDARY outcome

Timeframe: From randomization through the follow-up phase; up to the data-cut off of 31 July 2014; Maximum time to response was 23.1 weeks

Population: Includes those who had at least a partial response or better; Intent to Treat

Time to Response was calculated as the time from enrollment to the initial response (PR or better) based on IMWG and assessed by the investigator.

Outcome measures

Outcome measures
Measure	Pomalidomide n=17 Participants Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
Time to Response Based on IMWG and Assessed by the Investigator	8.3 weeks Interval 4.1 to 23.1

Adverse Events

Pomalidomide

Serious events: 52 serious events

Other events: 68 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pomalidomide n=73 participants at risk Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
Blood and lymphatic system disorders Anaemia	13.7% 10/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Blood and lymphatic system disorders Neutropenia	4.1% 3/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Blood and lymphatic system disorders Febrile neutropenia	2.7% 2/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Blood and lymphatic system disorders Thrombocytopenia	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Infections and infestations Pneumonia	15.1% 11/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Infections and infestations Bronchitis	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Infections and infestations Bronchopneumonia	2.7% 2/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Infections and infestations Neutropenic sepsis	2.7% 2/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Infections and infestations Sepsis	2.7% 2/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	5.5% 4/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Respiratory, thoracic and mediastinal disorders Lung disorder	2.7% 2/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Metabolism and nutrition disorders Diabetic ketoacidosis	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Metabolism and nutrition disorders Hypokalaemia	2.7% 2/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Metabolism and nutrition disorders Hypomagnesaemia	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Cardiac disorders Atrial fibrillation	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Gastrointestinal disorders Abdominal pain	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
General disorders Fatigue	2.7% 2/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
General disorders General physical health deterioration	11.0% 8/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
General disorders Asthenia	2.7% 2/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
General disorders Pyrexia	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Metabolism and nutrition disorders Hypercalcaemia	5.5% 4/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Metabolism and nutrition disorders Decreased appetite	2.7% 2/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Metabolism and nutrition disorders Cachexia	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Metabolism and nutrition disorders Dehydration	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Metabolism and nutrition disorders Hyperproteinaemia	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Infections and infestations Enterocolitis infectious	2.7% 2/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Infections and infestations Septic shock	2.7% 2/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Infections and infestations Cellulitis	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Infections and infestations Clostridium difficile colitis	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Infections and infestations Erysipelas	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Infections and infestations Gastroenteritis	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Infections and infestations Infection	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Infections and infestations Lower respiratory tract infection	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Infections and infestations Meningitis cryptococcal	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Infections and infestations Otitis media	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Infections and infestations Pneumonia streptococcal	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Infections and infestations Respiratory tract infection	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Infections and infestations Subcutaneous abscess	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Gastrointestinal disorders Diarrhoea	5.5% 4/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Gastrointestinal disorders Dysphagia	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Gastrointestinal disorders Intestinal infarction	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Gastrointestinal disorders Vomiting	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Renal and urinary disorders Renal failure acute	5.5% 4/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Renal and urinary disorders Renal failure	4.1% 3/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Cardiac disorders Cardiac failure	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Cardiac disorders Cardiac failure congestive	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Cardiac disorders Sinus tachycardia	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Musculoskeletal and connective tissue disorders Osteolysis	2.7% 2/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Musculoskeletal and connective tissue disorders Back pain	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of bladder	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Multiple myeloma	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Psychiatric disorders Confusional state	2.7% 2/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Injury, poisoning and procedural complications Hip fracture	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Nervous system disorders Spinal cord compression	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Vascular disorders Hypotension	1.4% 1/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.

Other adverse events

Other adverse events
Measure	Pomalidomide n=73 participants at risk Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
Blood and lymphatic system disorders Anaemia	49.3% 36/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Blood and lymphatic system disorders Neutropenia	47.9% 35/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Blood and lymphatic system disorders Thrombocytopenia	21.9% 16/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Blood and lymphatic system disorders Leukopenia	12.3% 9/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
General disorders Fatigue	21.9% 16/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
General disorders Pyrexia	17.8% 13/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
General disorders Asthenia	9.6% 7/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
General disorders Oedema peripheral	8.2% 6/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Gastrointestinal disorders Constipation	21.9% 16/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Gastrointestinal disorders Diarrhoea	15.1% 11/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Gastrointestinal disorders Nausea	12.3% 9/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Gastrointestinal disorders Vomiting	6.8% 5/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Musculoskeletal and connective tissue disorders Back pain	17.8% 13/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Musculoskeletal and connective tissue disorders Bone pain	16.4% 12/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Musculoskeletal and connective tissue disorders Arthralgia	6.8% 5/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Musculoskeletal and connective tissue disorders Muscle spasms	6.8% 5/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Respiratory, thoracic and mediastinal disorders Dyspnoea	20.5% 15/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Respiratory, thoracic and mediastinal disorders Cough	12.3% 9/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Infections and infestations Bronchitis	8.2% 6/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Infections and infestations Gastroenteritis	6.8% 5/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Infections and infestations Upper respiratory tract infection	6.8% 5/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Infections and infestations Urinary tract infection	6.8% 5/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Infections and infestations Nasopharyngitis	5.5% 4/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Metabolism and nutrition disorders Hypokalaemia	17.8% 13/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Metabolism and nutrition disorders Hypercalcaemia	15.1% 11/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Metabolism and nutrition disorders Decreased appetite	9.6% 7/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Nervous system disorders Headache	9.6% 7/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Skin and subcutaneous tissue disorders Hyperhidrosis	8.2% 6/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Investigations Weight decreased	8.2% 6/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Investigations Blood creatinine increased	5.5% 4/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Psychiatric disorders Insomnia	5.5% 4/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Renal and urinary disorders Renal failure	5.5% 4/73 • From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.

Additional Information

Anne McClain, Senior Manager, Clinical Trial Disclosure

Celgene Corporation

Phone: 888-260-1599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Institution may publish the results of its findings if a multicenter publication is not forthcoming within 18 months after study completion. Institution shall provide Celgene with a copy of the papers prior to submission; Celgene shall complete its review within 60 days after receipt. Upon Celgene's request, proposed publication or presentation will be delayed up to 60 additional days to enable Celgene to secure adequate intellectual property protection of patentable material.
Publication restrictions are in place

Restriction type: OTHER