Trial Outcomes & Findings for Pembrolizumab and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma (NCT NCT03077828)

Last Updated: 2023-06-02

Results Overview

To determine the complete response rate by FDG-PET/CT prior to AHSCT with the combination of pembrolizumab and ICE salvage chemotherapy for relapsed/refractory Hodgkin lymphoma. Response was assessed using Lugano criteria 2014. To address the primary aim, the proportion of patients with complete responses was calculated(defined as FDG-PET/CT Deauville score ≤ 3) as (number of responders) / (number of evaluable patients).

Recruitment status

UNKNOWN

Study phase

PHASE2

Target enrollment

43 participants

Primary outcome timeframe

Up to 59 days

Results posted on

2023-06-02

Participant Flow

The first patient started treatment 04/24/2017. The study was designed to enroll patients with relapsed/refractory classical Hodgkin lymphoma following standard up-front chemotherapy. The study was closed to further enrollment on 10/29/2020 due to meeting accrual goal.

Participant milestones

Participant milestones
Measure	Treatment Patients received treatment with combination pembrolizumab and ICE (ifosphamide, carboplatin, etoposide) salvage chemotherapy for 2 cycles (1 cycle = 21 days). Pembrolizumab 200 mg IV will be administered on day 1. Standard ICE salvage chemotherapy includes ifosfamide 5 g/m2 with equivalent dose of MESNA given over 24 hours by CIV on day 2, carboplatin AUC 5 IV with a maximum of 800 mg on day 2, and etoposide 100 mg/m\^2/day IV on days 1 to 3. G-CSF support administered 24 hours following completion of chemotherapy. On Cycle 3 day1, patients received pembrolizumab monotherapy. An FDG-PET/CT will be obtained 14-22 days after pembrolizumab monotherapy to assess response by Deauville criteria. Patients with Deauville \</= 3 will proceed to AHSCT which may include a 4th optional cycle of Pembro-ICE prior to transplant per investigator discretion. Patients with Deauville \>3 will be treated per provider's discretion which may also include stem cell transplant.
Treatment Cycles STARTED	43
Treatment Cycles Cycle 1	42
Treatment Cycles Cycle 2	39
Treatment Cycles Cycle 3	39
Treatment Cycles Optional Cycle 4	5
Treatment Cycles COMPLETED	39
Treatment Cycles NOT COMPLETED	4
Autologous Stem Cell Transplant STARTED	42
Autologous Stem Cell Transplant COMPLETED	38
Autologous Stem Cell Transplant NOT COMPLETED	4
Follow-up STARTED	39
Follow-up COMPLETED	24
Follow-up NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Patients received treatment with combination pembrolizumab and ICE (ifosphamide, carboplatin, etoposide) salvage chemotherapy for 2 cycles (1 cycle = 21 days). Pembrolizumab 200 mg IV will be administered on day 1. Standard ICE salvage chemotherapy includes ifosfamide 5 g/m2 with equivalent dose of MESNA given over 24 hours by CIV on day 2, carboplatin AUC 5 IV with a maximum of 800 mg on day 2, and etoposide 100 mg/m\^2/day IV on days 1 to 3. G-CSF support administered 24 hours following completion of chemotherapy. On Cycle 3 day1, patients received pembrolizumab monotherapy. An FDG-PET/CT will be obtained 14-22 days after pembrolizumab monotherapy to assess response by Deauville criteria. Patients with Deauville \</= 3 will proceed to AHSCT which may include a 4th optional cycle of Pembro-ICE prior to transplant per investigator discretion. Patients with Deauville \>3 will be treated per provider's discretion which may also include stem cell transplant.
Treatment Cycles Death	1
Treatment Cycles Withdrawal by Subject	1
Treatment Cycles Screen Fail	2
Autologous Stem Cell Transplant Adverse Event	1
Autologous Stem Cell Transplant Withdrawal by Subject	2
Autologous Stem Cell Transplant Physician Decision	1
Follow-up Patients still in follow-up	15

Baseline Characteristics

Pembrolizumab and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=43 Participants Patients received treatment with combination pembrolizumab and ICE (ifosphamide, carboplatin, etoposide) salvage chemotherapy for 2 cycles (1 cycle = 21 days). Pembrolizumab 200 mg IV will be administered on day 1. Standard ICE salvage chemotherapy includes ifosfamide 5 g/m2 with equivalent dose of MESNA given over 24 hours by CIV on day 2, carboplatin AUC 5 IV with a maximum of 800 mg on day 2, and etoposide 100 mg/m\^2/day IV on days 1 to 3. G-CSF support administered 24 hours following completion of chemotherapy. On Cycle 3 day1, patients received pembrolizumab monotherapy. An FDG-PET/CT will be obtained 14-22 days after pembrolizumab monotherapy to assess response by Deauville criteria. Patients with Deauville \</= 3 will proceed to AHSCT which may include a 4th optional cycle of Pembro-ICE prior to transplant per investigator discretion. Patients with Deauville \>3 will be treated per provider's discretion which may also include stem cell transplant.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 59 days

Population: Of the 42 registered study patients, 37 were evaluable for response. To be evaluable for inclusion in the analysis to address the primary objective, patients must: * have received at least dose of pembrolizumab AND * have a FDG-PET/CT scan following cycle #3

Outcome measures

Outcome measures
Measure	Treatment n=37 Participants Patients receive pembrolizumab IV over 30 minutes on day 1, etoposide IV over 60 minutes on days 1-3 of courses 1-2, carboplatin IV over 60 minutes on day 2 of courses 1-2, and ifosfamide IV over 24 hours on day 2 of courses 1-2. Pembrolizumab in combination with ICE chemotherapy repeats every 21 days for 2 courses, patients will then receive pembrolizumab as monotherapy on course 3. Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV
Complete Response Rate Complete Repsonse	32 Participants
Complete Response Rate Partial Response	4 Participants
Complete Response Rate Progressive Disease	1 Participants

SECONDARY outcome

Timeframe: Up to 2 years

Evaluate the safety and tolerability of pembrolizumab in combination with ICE salvage high-dose chemotherapy by measuring the frequency and severity of adverse events by type, severity (grade), timing, and attribution to pembrolizumab which will be assessed according the NCI-CTCAE version 4.03.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

EFS will be defined as the length of time from treatment on protocol until the first occurrence of disease relapse, progression, re-initiation of cytotoxic chemotherapy, or death due to disease, or until last contact if the patient did not experience any of these, assessed up to 2 years.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

OS will be defined as time from study enrollment until death, or until last contact if the patient did not die, assessed up to 2 years.

Outcome measures

Outcome data not reported

Adverse Events

Treatment

Serious events: 17 serious events

Other events: 42 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Treatment n=42 participants at risk Patients receive pembrolizumab IV over 30 minutes on day 1, etoposide IV over 60 minutes on days 1-3 of courses 1-2, carboplatin IV over 60 minutes on day 2 of courses 1-2, and ifosfamide IV over 24 hours on day 2 of courses 1-2. Pembrolizumab in combination with ICE chemotherapy repeats every 21 days for 2 courses, patients will then receive pembrolizumab as monotherapy on course 3. Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	2.4% 1/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Cardiac disorders Ventricular fibrillation	2.4% 1/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
General disorders Fever	4.8% 2/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Blood and lymphatic system disorders Lymphocyte count decreased	4.8% 2/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Blood and lymphatic system disorders Platelet count decrease	4.8% 2/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Infections and infestations Sepsis	4.8% 2/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Renal and urinary disorders Acute kidney injury	2.4% 1/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Blood and lymphatic system disorders Anemia	2.4% 1/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Musculoskeletal and connective tissue disorders Back Pain	2.4% 1/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Cardiac disorders Ejection fraction decrease	2.4% 1/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Nervous system disorders Encephalopathy	2.4% 1/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Blood and lymphatic system disorders Febrile neutropenia	2.4% 1/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Vascular disorders Hematoma	2.4% 1/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Metabolism and nutrition disorders Hyperglycemia	2.4% 1/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Metabolism and nutrition disorders Hyponatremia	2.4% 1/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
General disorders Infusion related reaction	2.4% 1/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Respiratory, thoracic and mediastinal disorders Lung infection	2.4% 1/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Investigations Engraftment syndrome	2.4% 1/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Gastrointestinal disorders Mucositis Oral	2.4% 1/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Musculoskeletal and connective tissue disorders Non-cardiac chest pain	2.4% 1/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Cardiac disorders Pericardial tamponade	2.4% 1/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Reproductive system and breast disorders Respiratory failure	2.4% 1/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Skin and subcutaneous tissue disorders Skin infection	2.4% 1/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Nervous system disorders Syncope	2.4% 1/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Pregnancy, puerperium and perinatal conditions Unintended pregnancy	2.4% 1/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.

Other adverse events

Other adverse events
Measure	Treatment n=42 participants at risk Patients receive pembrolizumab IV over 30 minutes on day 1, etoposide IV over 60 minutes on days 1-3 of courses 1-2, carboplatin IV over 60 minutes on day 2 of courses 1-2, and ifosfamide IV over 24 hours on day 2 of courses 1-2. Pembrolizumab in combination with ICE chemotherapy repeats every 21 days for 2 courses, patients will then receive pembrolizumab as monotherapy on course 3. Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV
Blood and lymphatic system disorders Anemia	97.6% 41/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Blood and lymphatic system disorders Lymphocyte count decrease	97.6% 41/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Blood and lymphatic system disorders Platelet count decrease	97.6% 41/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Blood and lymphatic system disorders White blood cell decreased	95.2% 40/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Blood and lymphatic system disorders Neutrophil count decreased	90.5% 38/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Gastrointestinal disorders Nausea	83.3% 35/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Investigations Aspartate aminotransferase increased	78.6% 33/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Metabolism and nutrition disorders Hypoalbuminemia	78.6% 33/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Metabolism and nutrition disorders Hypokalemia	78.6% 33/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Investigations Alanine aminotransferase increased	76.2% 32/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Metabolism and nutrition disorders Hyperglycemia	73.8% 31/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Metabolism and nutrition disorders Hypocalcemia	73.8% 31/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Investigations Alkaline phosphatase increased	69.0% 29/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Gastrointestinal disorders Diarrhea	69.0% 29/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Metabolism and nutrition disorders Hypophosphatemia	57.1% 24/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Respiratory, thoracic and mediastinal disorders Hypertension	54.8% 23/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Gastrointestinal disorders Vomiting	52.4% 22/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Gastrointestinal disorders Constipation	50.0% 21/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
General disorders Fever	50.0% 21/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Metabolism and nutrition disorders Hyponatremia	47.6% 20/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Gastrointestinal disorders Mucositis oral	47.6% 20/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
General disorders Fatigue	40.5% 17/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Nervous system disorders Headache	38.1% 16/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Skin and subcutaneous tissue disorders Alopecia	35.7% 15/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Vascular disorders Hypotension	35.7% 15/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Gastrointestinal disorders Abdominal pain	33.3% 14/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Psychiatric disorders Insomnia	33.3% 14/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Metabolism and nutrition disorders Hypomagnesemia	31.0% 13/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Skin and subcutaneous tissue disorders Maculopapular rash	31.0% 13/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Metabolism and nutrition disorders Anorexia	28.6% 12/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Blood and lymphatic system disorders Febrile neutropenia	28.6% 12/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
General disorders Pain	28.6% 12/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Cardiac disorders Sinus tachycardia	28.6% 12/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Respiratory, thoracic and mediastinal disorders Sore throat	28.6% 12/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Gastrointestinal disorders Gastroesophageal reflux disease	26.2% 11/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
General disorders Chills	23.8% 10/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Psychiatric disorders Anxiety	21.4% 9/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Nervous system disorders Dizziness	21.4% 9/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Gastrointestinal disorders Dry mouth	21.4% 9/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Skin and subcutaneous tissue disorders Pruritus	21.4% 9/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Musculoskeletal and connective tissue disorders Back pain	19.0% 8/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Musculoskeletal and connective tissue disorders Bone pain	19.0% 8/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Respiratory, thoracic and mediastinal disorders Dyspnea	19.0% 8/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Metabolism and nutrition disorders Weight loss	19.0% 8/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 7/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Investigations Creatinine increased	16.7% 7/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Gastrointestinal disorders Esophagitis	16.7% 7/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Gastrointestinal disorders Gastrointestinal disorders - Other	16.7% 7/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Infections and infestations Infections and infestations - Other	16.7% 7/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Musculoskeletal and connective tissue disorders Non-cardiac chest pain	14.3% 6/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Gastrointestinal disorders Oral Pain	14.3% 6/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Infections and infestations Sepsis	14.3% 6/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Investigations Blood bilirubin increase	11.9% 5/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
General disorders Edema limbs	11.9% 5/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Respiratory, thoracic and mediastinal disorders Epistaxis	11.9% 5/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
General disorders General disorders and administration site conditions - Other	11.9% 5/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Vascular disorders Hot flashes	11.9% 5/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Metabolism and nutrition disorders Hyperkalemia	11.9% 5/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Metabolism and nutrition disorders Hypoglycemia	11.9% 5/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	11.9% 5/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Cardiac disorders Sinus bradycardia	11.9% 5/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Gastrointestinal disorders Bloating	9.5% 4/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Cardiac disorders Cardiac disorders - Other	9.5% 4/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Metabolism and nutrition disorders Dehydration	9.5% 4/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Psychiatric disorders Depression	9.5% 4/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Skin and subcutaneous tissue disorders Dry skin	9.5% 4/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Skin and subcutaneous tissue disorders Erythema multiforme	9.5% 4/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
General disorders Localized edema	9.5% 4/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Infections and infestations Lung infection	9.5% 4/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Respiratory, thoracic and mediastinal disorders Nasal congestion	9.5% 4/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Musculoskeletal and connective tissue disorders pain in extremity	9.5% 4/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Injury, poisoning and procedural complications radiation recall reaction (dermtologic)	9.5% 4/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	9.5% 4/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Skin and subcutaneous tissue disorders Skin infection	9.5% 4/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Nervous system disorders Dysgeusia	7.1% 3/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Gastrointestinal disorders Dyspepsia	7.1% 3/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Metabolism and nutrition disorders Hypercalcemia	7.1% 3/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Skin and subcutaneous tissue disorders Hyperhidrosis	7.1% 3/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Metabolism and nutrition disorders Hypernatremia	7.1% 3/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Nervous system disorders Lethargy	7.1% 3/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	7.1% 3/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Musculoskeletal and connective tissue disorders Neck pain	7.1% 3/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Respiratory, thoracic and mediastinal disorders Productive cough	7.1% 3/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Skin and subcutaneous tissue disorders Rash acneiform	7.1% 3/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Renal and urinary disorders Renal and urinary disorders - Other	7.1% 3/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Nervous system disorders Syncope	7.1% 3/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Nervous system disorders Tremor	7.1% 3/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Renal and urinary disorders Urinary tract infection	7.1% 3/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.
Injury, poisoning and procedural complications Vascular access complication	7.1% 3/42 • All adverse events were monitored and recorded from the time of consent for up to four cycles of treatment,( 1 Cycle = 21 days) during stem-cell transplant ( up to 42 days after the last cycle) and up to 180 days post stem-cell transplant. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data.

Additional Information

Dr. Jane N. Winter, M.D.

Northwestern University

Phone: 3126954538

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place