Trial Outcomes & Findings for BiRd vs. Rd as Initial Therapy in Multiple Myeloma (NCT NCT02516696)

Last Updated: 2023-06-05

Results Overview

Calculate rate of progression-free survival for subjects following treatment BiRd regimen compared to Rd treatment regimen. Progression is determined by the International Myeloma Working Group Criteria.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

12 participants

Primary outcome timeframe

Until disease progression or death from any cause, for a maximum of approximately 5 years

Results posted on

2023-06-05

Participant Flow

Participant milestones

Participant milestones
Measure	BiRD Treatment Regimen Subjects on the BiRD arm will receive clarithromycin, lenalidomide, and dexamethasone in 28-day cycles. Clarithromycin: 500mg PO twice daily on days 1-28 for a 28-day cycle. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.	Rd Treatment Regimen Subjects on the Rd arm will receive lenalidomide and dexamethasone in 28-day cycles. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.
Overall Study STARTED	7	5
Overall Study COMPLETED	7	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

BiRd vs. Rd as Initial Therapy in Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BiRD Treatment Regimen n=7 Participants Subjects on the BiRD arm will receive clarithromycin, lenalidomide, and dexamethasone in 28-day cycles. Clarithromycin: 500mg PO twice daily on days 1-28 for a 28-day cycle. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.	Rd Treatment Regimen n=5 Participants Subjects on the Rd arm will receive lenalidomide and dexamethasone in 28-day cycles. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical >=65 years	7 Participants n=99 Participants	5 Participants n=107 Participants	12 Participants n=206 Participants
Sex: Female, Male Female	5 Participants n=99 Participants	2 Participants n=107 Participants	7 Participants n=206 Participants
Sex: Female, Male Male	2 Participants n=99 Participants	3 Participants n=107 Participants	5 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=99 Participants	4 Participants n=107 Participants	11 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Race (NIH/OMB) White	4 Participants n=99 Participants	2 Participants n=107 Participants	6 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants
Region of Enrollment United States	7 participants n=99 Participants	5 participants n=107 Participants	12 participants n=206 Participants

PRIMARY outcome

Timeframe: Until disease progression or death from any cause, for a maximum of approximately 5 years

Outcome measures

Outcome measures
Measure	BiRD Treatment Regimen n=7 Participants Subjects on the BiRD arm will receive clarithromycin, lenalidomide, and dexamethasone in 28-day cycles. Clarithromycin: 500mg PO twice daily on days 1-28 for a 28-day cycle. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.	Rd Treatment Regimen n=5 Participants Subjects on the Rd arm will receive lenalidomide and dexamethasone in 28-day cycles. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.
Survival Duration Without Disease Progression	661 days Interval 586.0 to Some participants were still alive without disease progression at the time of study completion.	1694 days Interval 821.0 to Some participants were still alive without disease progression at the time of study completion.

SECONDARY outcome

Timeframe: 2 years

Capture the number of subjects who demonstrate a complete or partial response to treatment with BiRD regimen, as compared to Rd. Complete and partial responses are defined by the International Myeloma Working Group Criteria.

Outcome measures

Outcome measures
Measure	BiRD Treatment Regimen n=7 Participants Subjects on the BiRD arm will receive clarithromycin, lenalidomide, and dexamethasone in 28-day cycles. Clarithromycin: 500mg PO twice daily on days 1-28 for a 28-day cycle. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.	Rd Treatment Regimen n=5 Participants Subjects on the Rd arm will receive lenalidomide and dexamethasone in 28-day cycles. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.
Overall Response Rate	7 Participants	4 Participants

SECONDARY outcome

Timeframe: 2 years

Capture the number of adverse events experienced with BiRd regimen as compared to Rd regimen

Outcome measures

Outcome measures
Measure	BiRD Treatment Regimen n=7 Participants Subjects on the BiRD arm will receive clarithromycin, lenalidomide, and dexamethasone in 28-day cycles. Clarithromycin: 500mg PO twice daily on days 1-28 for a 28-day cycle. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.	Rd Treatment Regimen n=5 Participants Subjects on the Rd arm will receive lenalidomide and dexamethasone in 28-day cycles. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.
Number of Adverse Events Experienced	79 adverse events	67 adverse events

SECONDARY outcome

Timeframe: 4 years

Survival following treatment to the date of death of subjects on BiRd regimen as compared to Rd.

Outcome measures

Outcome measures
Measure	BiRD Treatment Regimen n=7 Participants Subjects on the BiRD arm will receive clarithromycin, lenalidomide, and dexamethasone in 28-day cycles. Clarithromycin: 500mg PO twice daily on days 1-28 for a 28-day cycle. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.	Rd Treatment Regimen n=5 Participants Subjects on the Rd arm will receive lenalidomide and dexamethasone in 28-day cycles. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.
Overall Survival	NA days Interval 906.0 to Median overall survival was not reached for patients in the BiRd arm (95% CI: 906-NA).	1014 days Interval 821.0 to Participants were still alive at the time of study closure.

SECONDARY outcome

Timeframe: Until disease progression for a maximum of approximately 5 years

Progression is determined by the International Myeloma Working Group Criteria.

Outcome measures

Outcome measures
Measure	BiRD Treatment Regimen n=7 Participants Subjects on the BiRD arm will receive clarithromycin, lenalidomide, and dexamethasone in 28-day cycles. Clarithromycin: 500mg PO twice daily on days 1-28 for a 28-day cycle. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.	Rd Treatment Regimen n=5 Participants Subjects on the Rd arm will receive lenalidomide and dexamethasone in 28-day cycles. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.
Number of Days After Initiating Treatment With BiRd Regimen to Disease Progression, as Compared to Subjects on Rd Treatment Regimen.	661 days Interval 661.0 to Not all participants progressed at the time of study completion.	1694 days Not all participants progressed at the time of study completion.

SECONDARY outcome

Timeframe: up to 3 years

Outcome measures

Outcome measures
Measure	BiRD Treatment Regimen n=7 Participants Subjects on the BiRD arm will receive clarithromycin, lenalidomide, and dexamethasone in 28-day cycles. Clarithromycin: 500mg PO twice daily on days 1-28 for a 28-day cycle. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.	Rd Treatment Regimen n=5 Participants Subjects on the Rd arm will receive lenalidomide and dexamethasone in 28-day cycles. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.
Number of Patients With Objective Response Rate (CR+PR)	7 Participants	4 Participants

SECONDARY outcome

Timeframe: up to 3 years

Complete response is defined by the International Myeloma Working Group Criteria.

Outcome measures

Outcome measures
Measure	BiRD Treatment Regimen n=7 Participants Subjects on the BiRD arm will receive clarithromycin, lenalidomide, and dexamethasone in 28-day cycles. Clarithromycin: 500mg PO twice daily on days 1-28 for a 28-day cycle. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.	Rd Treatment Regimen n=5 Participants Subjects on the Rd arm will receive lenalidomide and dexamethasone in 28-day cycles. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.
Number of Patients With Complete Response Rate (CR)	2 Participants	0 Participants

SECONDARY outcome

Timeframe: approximately 5 years

Descriptively presented for each treatment group and no formal statistical comparison will be made between treatment arms

Outcome measures

Outcome measures
Measure	BiRD Treatment Regimen n=7 Participants Subjects on the BiRD arm will receive clarithromycin, lenalidomide, and dexamethasone in 28-day cycles. Clarithromycin: 500mg PO twice daily on days 1-28 for a 28-day cycle. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.	Rd Treatment Regimen n=5 Participants Subjects on the Rd arm will receive lenalidomide and dexamethasone in 28-day cycles. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.
Number of Days for Event-Free Survival	336 days Interval 225.0 to Not all patients progressed by the time of study completion.	821 days Interval 310.0 to Not all patients progressed by the time of study completion.

SECONDARY outcome

Timeframe: up to 3 years

Descriptively presented for each treatment group and no formal statistical comparison will be made between treatment arms

Outcome measures

Outcome measures
Measure	BiRD Treatment Regimen n=7 Participants Subjects on the BiRD arm will receive clarithromycin, lenalidomide, and dexamethasone in 28-day cycles. Clarithromycin: 500mg PO twice daily on days 1-28 for a 28-day cycle. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.	Rd Treatment Regimen n=5 Participants Subjects on the Rd arm will receive lenalidomide and dexamethasone in 28-day cycles. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.
Number of Days for Duration of Response	308 days Interval 227.0 to Some participants continued to have a sustained response at the time of study completion.	803 days Interval 282.0 to Some participants continued to have a sustained response at the time of study completion.

SECONDARY outcome

Timeframe: approximately 5 years

Population: Data not collected due to early trial termination due to low accrual.

Time from study entry until 2nd instance of disease progression. Progression is determined by the International Myeloma Working Group Criteria. Descriptively presented for each treatment group and no formal statistical comparison will be made between treatment arms.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 3 years

The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a 40-item measure that assesses self-reported fatigue and its impact upon daily activities and function. The FACIT- Fatigue Subscore (FS) is comprised of 13 items, within the total 40-item FACIT-F, that assess fatigue and its impact. This analysis is only based on the FS score. Items are scored on a 5 point Likert-type scale. Item scores can range from 0 ("not at all") to 4 ("very much"), and the total, summed score from 0 to 52; lower scores indicate greater fatigue. The recall period for each item is the past 7 days. Data is descriptively presented for each treatment group and no formal statistical comparison will be made between treatment arms.

Outcome measures

Outcome measures
Measure	BiRD Treatment Regimen n=7 Participants Subjects on the BiRD arm will receive clarithromycin, lenalidomide, and dexamethasone in 28-day cycles. Clarithromycin: 500mg PO twice daily on days 1-28 for a 28-day cycle. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.	Rd Treatment Regimen n=2 Participants Subjects on the Rd arm will receive lenalidomide and dexamethasone in 28-day cycles. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.
Functional Assessment of Chronic Illness Therapy - Fatigue Subscale (FS; Version 4) Score of Patients Receiving BiRd vs Rd Treatment	32.75 Score on a scale Interval 16.9 to 45.46	37.24 Score on a scale Interval 28.58 to 45.89

Adverse Events

BiRD Treatment Regimen

Serious events: 6 serious events

Other events: 7 other events

Deaths: 2 deaths

Rd Treatment Regimen

Serious events: 3 serious events

Other events: 5 other events

Deaths: 4 deaths

Serious adverse events

Other adverse events

Additional Information

Multiple Myeloma Program Manager

Weill Cornell Medicine

Phone: 646.962.9376

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	BiRD Treatment Regimen n=7 participants at risk Subjects on the BiRD arm will receive clarithromycin, lenalidomide, and dexamethasone in 28-day cycles. Clarithromycin: 500mg PO twice daily on days 1-28 for a 28-day cycle. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.	Rd Treatment Regimen n=5 participants at risk Subjects on the Rd arm will receive lenalidomide and dexamethasone in 28-day cycles. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.
Gastrointestinal disorders Constipation	0.00% 0/7 • Adverse events were collected from the time of informed consent until participants were removed from the study, or for a maximum of 60 months. Participants were removed at the time of disease progression, death, or study termination, whichever occurred first. This study was terminated early due to low accrual.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of informed consent until participants were removed from the study, or for a maximum of 60 months. Participants were removed at the time of disease progression, death, or study termination, whichever occurred first. This study was terminated early due to low accrual.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Secondary Primary Malignancy	0.00% 0/7 • Adverse events were collected from the time of informed consent until participants were removed from the study, or for a maximum of 60 months. Participants were removed at the time of disease progression, death, or study termination, whichever occurred first. This study was terminated early due to low accrual.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of informed consent until participants were removed from the study, or for a maximum of 60 months. Participants were removed at the time of disease progression, death, or study termination, whichever occurred first. This study was terminated early due to low accrual.
Skin and subcutaneous tissue disorders Cellulitis	14.3% 1/7 • Number of events 1 • Adverse events were collected from the time of informed consent until participants were removed from the study, or for a maximum of 60 months. Participants were removed at the time of disease progression, death, or study termination, whichever occurred first. This study was terminated early due to low accrual.	0.00% 0/5 • Adverse events were collected from the time of informed consent until participants were removed from the study, or for a maximum of 60 months. Participants were removed at the time of disease progression, death, or study termination, whichever occurred first. This study was terminated early due to low accrual.
General disorders Allergic Reaction	14.3% 1/7 • Number of events 1 • Adverse events were collected from the time of informed consent until participants were removed from the study, or for a maximum of 60 months. Participants were removed at the time of disease progression, death, or study termination, whichever occurred first. This study was terminated early due to low accrual.	0.00% 0/5 • Adverse events were collected from the time of informed consent until participants were removed from the study, or for a maximum of 60 months. Participants were removed at the time of disease progression, death, or study termination, whichever occurred first. This study was terminated early due to low accrual.
Renal and urinary disorders Urinary Tract Infection	14.3% 1/7 • Number of events 1 • Adverse events were collected from the time of informed consent until participants were removed from the study, or for a maximum of 60 months. Participants were removed at the time of disease progression, death, or study termination, whichever occurred first. This study was terminated early due to low accrual.	0.00% 0/5 • Adverse events were collected from the time of informed consent until participants were removed from the study, or for a maximum of 60 months. Participants were removed at the time of disease progression, death, or study termination, whichever occurred first. This study was terminated early due to low accrual.
General disorders Fall	28.6% 2/7 • Number of events 3 • Adverse events were collected from the time of informed consent until participants were removed from the study, or for a maximum of 60 months. Participants were removed at the time of disease progression, death, or study termination, whichever occurred first. This study was terminated early due to low accrual.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of informed consent until participants were removed from the study, or for a maximum of 60 months. Participants were removed at the time of disease progression, death, or study termination, whichever occurred first. This study was terminated early due to low accrual.
Respiratory, thoracic and mediastinal disorders Acute Hypoxic Respiratory Failure	14.3% 1/7 • Number of events 1 • Adverse events were collected from the time of informed consent until participants were removed from the study, or for a maximum of 60 months. Participants were removed at the time of disease progression, death, or study termination, whichever occurred first. This study was terminated early due to low accrual.	0.00% 0/5 • Adverse events were collected from the time of informed consent until participants were removed from the study, or for a maximum of 60 months. Participants were removed at the time of disease progression, death, or study termination, whichever occurred first. This study was terminated early due to low accrual.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	14.3% 1/7 • Number of events 1 • Adverse events were collected from the time of informed consent until participants were removed from the study, or for a maximum of 60 months. Participants were removed at the time of disease progression, death, or study termination, whichever occurred first. This study was terminated early due to low accrual.	0.00% 0/5 • Adverse events were collected from the time of informed consent until participants were removed from the study, or for a maximum of 60 months. Participants were removed at the time of disease progression, death, or study termination, whichever occurred first. This study was terminated early due to low accrual.
General disorders Syncope	28.6% 2/7 • Number of events 2 • Adverse events were collected from the time of informed consent until participants were removed from the study, or for a maximum of 60 months. Participants were removed at the time of disease progression, death, or study termination, whichever occurred first. This study was terminated early due to low accrual.	0.00% 0/5 • Adverse events were collected from the time of informed consent until participants were removed from the study, or for a maximum of 60 months. Participants were removed at the time of disease progression, death, or study termination, whichever occurred first. This study was terminated early due to low accrual.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/7 • Adverse events were collected from the time of informed consent until participants were removed from the study, or for a maximum of 60 months. Participants were removed at the time of disease progression, death, or study termination, whichever occurred first. This study was terminated early due to low accrual.	20.0% 1/5 • Number of events 3 • Adverse events were collected from the time of informed consent until participants were removed from the study, or for a maximum of 60 months. Participants were removed at the time of disease progression, death, or study termination, whichever occurred first. This study was terminated early due to low accrual.
Renal and urinary disorders Acute Kidney Injury	0.00% 0/7 • Adverse events were collected from the time of informed consent until participants were removed from the study, or for a maximum of 60 months. Participants were removed at the time of disease progression, death, or study termination, whichever occurred first. This study was terminated early due to low accrual.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of informed consent until participants were removed from the study, or for a maximum of 60 months. Participants were removed at the time of disease progression, death, or study termination, whichever occurred first. This study was terminated early due to low accrual.
Cardiac disorders Atrial Fibrillation	0.00% 0/7 • Adverse events were collected from the time of informed consent until participants were removed from the study, or for a maximum of 60 months. Participants were removed at the time of disease progression, death, or study termination, whichever occurred first. This study was terminated early due to low accrual.	20.0% 1/5 • Number of events 3 • Adverse events were collected from the time of informed consent until participants were removed from the study, or for a maximum of 60 months. Participants were removed at the time of disease progression, death, or study termination, whichever occurred first. This study was terminated early due to low accrual.
General disorders Edema Limbs	0.00% 0/7 • Adverse events were collected from the time of informed consent until participants were removed from the study, or for a maximum of 60 months. Participants were removed at the time of disease progression, death, or study termination, whichever occurred first. This study was terminated early due to low accrual.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of informed consent until participants were removed from the study, or for a maximum of 60 months. Participants were removed at the time of disease progression, death, or study termination, whichever occurred first. This study was terminated early due to low accrual.
Skin and subcutaneous tissue disorders Skin Infection	0.00% 0/7 • Adverse events were collected from the time of informed consent until participants were removed from the study, or for a maximum of 60 months. Participants were removed at the time of disease progression, death, or study termination, whichever occurred first. This study was terminated early due to low accrual.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of informed consent until participants were removed from the study, or for a maximum of 60 months. Participants were removed at the time of disease progression, death, or study termination, whichever occurred first. This study was terminated early due to low accrual.
Infections and infestations COVID-19 Infection	0.00% 0/7 • Adverse events were collected from the time of informed consent until participants were removed from the study, or for a maximum of 60 months. Participants were removed at the time of disease progression, death, or study termination, whichever occurred first. This study was terminated early due to low accrual.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of informed consent until participants were removed from the study, or for a maximum of 60 months. Participants were removed at the time of disease progression, death, or study termination, whichever occurred first. This study was terminated early due to low accrual.