Trial Outcomes & Findings for Melphalan Hydrochloride in Treating Participants With Newly-Diagnosed Multiple Myeloma Undergoing Donor Stem Cell Transplantation (NCT NCT03417284)
NCT ID: NCT03417284
Last Updated: 2025-05-01
Results Overview
Dose limiting toxicity will be defined as grade 4 mucositis or any grade 4 or 5 non-hematologic or non-infectious toxicity occurring within 30 days from the start of infusion.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
62 participants
Primary outcome timeframe
Within 30 days after the start of infusion
Results posted on
2025-05-01
Participant Flow
All participants were registered in MD Anderson Cancer Center.
Participant milestones
| Measure |
Group1_Dose 1 200mgm2
PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT
Filgrastim-sndz: Given SC
Melphalan Hydrochloride: Given IV
|
Group 1_Dose 2 225mgm2
PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT
Filgrastim-sndz: Given SC
Melphalan Hydrochloride: Given IV
|
Group 2_Dose 1 200mgm2
PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT
Filgrastim-sndz: Given SC
Melphalan Hydrochloride: Given IV
|
Group 2_Dose 225mgm2
PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT
Filgrastim-sndz: Given SC
Melphalan Hydrochloride: Given IV
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
27
|
4
|
27
|
|
Overall Study
COMPLETED
|
3
|
27
|
3
|
27
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group1_Dose 1 200mgm2
PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT
Filgrastim-sndz: Given SC
Melphalan Hydrochloride: Given IV
|
Group 1_Dose 2 225mgm2
PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT
Filgrastim-sndz: Given SC
Melphalan Hydrochloride: Given IV
|
Group 2_Dose 1 200mgm2
PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT
Filgrastim-sndz: Given SC
Melphalan Hydrochloride: Given IV
|
Group 2_Dose 225mgm2
PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT
Filgrastim-sndz: Given SC
Melphalan Hydrochloride: Given IV
|
|---|---|---|---|---|
|
Overall Study
Inadequate supply on study drug
|
1
|
0
|
0
|
0
|
|
Overall Study
Disease Progression
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Melphalan Hydrochloride in Treating Participants With Newly-Diagnosed Multiple Myeloma Undergoing Donor Stem Cell Transplantation
Baseline characteristics by cohort
| Measure |
Group1_Dose 1 200mgm2
n=4 Participants
PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT
Filgrastim-sndz: Given SC
Melphalan Hydrochloride: Given IV
|
Group 1_Dose 2 225mgm2
n=27 Participants
PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT
Filgrastim-sndz: Given SC
Melphalan Hydrochloride: Given IV
|
Group 2_Dose 1 200mgm2
n=4 Participants
PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT
Filgrastim-sndz: Given SC
Melphalan Hydrochloride: Given IV
|
Group 2_Dose 225mgm2
n=27 Participants
PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT
Filgrastim-sndz: Given SC
Melphalan Hydrochloride: Given IV
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
27 participants
n=7 Participants
|
4 participants
n=5 Participants
|
27 participants
n=4 Participants
|
62 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Within 30 days after the start of infusionDose limiting toxicity will be defined as grade 4 mucositis or any grade 4 or 5 non-hematologic or non-infectious toxicity occurring within 30 days from the start of infusion.
Outcome measures
| Measure |
Group1_Dose 1 200mgm2
n=4 Participants
PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT
Filgrastim-sndz: Given SC
Melphalan Hydrochloride: Given IV
|
Group 1_Dose 2 225mgm2
n=27 Participants
PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT
Filgrastim-sndz: Given SC
Melphalan Hydrochloride: Given IV
|
Group 2_Dose 1 200mgm2
n=4 Participants
PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT
Filgrastim-sndz: Given SC
Melphalan Hydrochloride: Given IV
|
Group 2_Dose 225mgm2
n=27 Participants
PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT
Filgrastim-sndz: Given SC
Melphalan Hydrochloride: Given IV
|
|---|---|---|---|---|
|
Optimal Dose and Schedule of Evomela Prior to Autologous Transplant.
Grade 4 Mucositis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Optimal Dose and Schedule of Evomela Prior to Autologous Transplant.
Grade 4 non-hematologic or non-infectious toxicity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From the date of Evomela injection up to 1 yearNumber of participants that are still alive and disease free one year post autologous transplant.
Outcome measures
| Measure |
Group1_Dose 1 200mgm2
n=4 Participants
PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT
Filgrastim-sndz: Given SC
Melphalan Hydrochloride: Given IV
|
Group 1_Dose 2 225mgm2
n=27 Participants
PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT
Filgrastim-sndz: Given SC
Melphalan Hydrochloride: Given IV
|
Group 2_Dose 1 200mgm2
n=4 Participants
PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT
Filgrastim-sndz: Given SC
Melphalan Hydrochloride: Given IV
|
Group 2_Dose 225mgm2
n=27 Participants
PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT
Filgrastim-sndz: Given SC
Melphalan Hydrochloride: Given IV
|
|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
2 Participants
|
21 Participants
|
2 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: At day 90 post-transplantNumber of participants expired from non-disease relapse within 90 days post transplant
Outcome measures
| Measure |
Group1_Dose 1 200mgm2
n=4 Participants
PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT
Filgrastim-sndz: Given SC
Melphalan Hydrochloride: Given IV
|
Group 1_Dose 2 225mgm2
n=27 Participants
PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT
Filgrastim-sndz: Given SC
Melphalan Hydrochloride: Given IV
|
Group 2_Dose 1 200mgm2
n=4 Participants
PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT
Filgrastim-sndz: Given SC
Melphalan Hydrochloride: Given IV
|
Group 2_Dose 225mgm2
n=27 Participants
PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT
Filgrastim-sndz: Given SC
Melphalan Hydrochloride: Given IV
|
|---|---|---|---|---|
|
Treatment Related Mortality (TRM).
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At 90 days post-transplantNumber of participants that have achieved Complete response (CR). Complete response definition is negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow aspirates.
Outcome measures
| Measure |
Group1_Dose 1 200mgm2
n=4 Participants
PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT
Filgrastim-sndz: Given SC
Melphalan Hydrochloride: Given IV
|
Group 1_Dose 2 225mgm2
n=27 Participants
PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT
Filgrastim-sndz: Given SC
Melphalan Hydrochloride: Given IV
|
Group 2_Dose 1 200mgm2
n=4 Participants
PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT
Filgrastim-sndz: Given SC
Melphalan Hydrochloride: Given IV
|
Group 2_Dose 225mgm2
n=27 Participants
PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT
Filgrastim-sndz: Given SC
Melphalan Hydrochloride: Given IV
|
|---|---|---|---|---|
|
Number of Participants That Have Achieved Complete Response (CR).
|
1 Participants
|
13 Participants
|
2 Participants
|
13 Participants
|
Adverse Events
Group1_Dose 1 200mgm2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Group 1_Dose 2 225mgm2
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Group 2_Dose 1 200mgm2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 2_Dose 225mgm2
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group1_Dose 1 200mgm2
n=4 participants at risk
PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT
Filgrastim-sndz: Given SC
Melphalan Hydrochloride: Given IV
|
Group 1_Dose 2 225mgm2
n=27 participants at risk
PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT
Filgrastim-sndz: Given SC
Melphalan Hydrochloride: Given IV
|
Group 2_Dose 1 200mgm2
n=4 participants at risk
PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT
Filgrastim-sndz: Given SC
Melphalan Hydrochloride: Given IV
|
Group 2_Dose 225mgm2
n=27 participants at risk
PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT
Filgrastim-sndz: Given SC
Melphalan Hydrochloride: Given IV
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • Up to one year
|
3.7%
1/27 • Number of events 1 • Up to one year
|
0.00%
0/4 • Up to one year
|
0.00%
0/27 • Up to one year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Up to one year
|
29.6%
8/27 • Number of events 8 • Up to one year
|
25.0%
1/4 • Number of events 1 • Up to one year
|
29.6%
8/27 • Number of events 8 • Up to one year
|
|
Investigations
ALK increased
|
0.00%
0/4 • Up to one year
|
3.7%
1/27 • Number of events 1 • Up to one year
|
0.00%
0/4 • Up to one year
|
3.7%
1/27 • Number of events 1 • Up to one year
|
|
Investigations
ALT increased
|
0.00%
0/4 • Up to one year
|
18.5%
5/27 • Number of events 5 • Up to one year
|
0.00%
0/4 • Up to one year
|
18.5%
5/27 • Number of events 5 • Up to one year
|
|
Investigations
AST increased
|
0.00%
0/4 • Up to one year
|
18.5%
5/27 • Number of events 5 • Up to one year
|
0.00%
0/4 • Up to one year
|
18.5%
5/27 • Number of events 5 • Up to one year
|
|
Infections and infestations
Bacterial
|
25.0%
1/4 • Number of events 1 • Up to one year
|
3.7%
1/27 • Number of events 1 • Up to one year
|
25.0%
1/4 • Number of events 1 • Up to one year
|
11.1%
3/27 • Number of events 3 • Up to one year
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/4 • Up to one year
|
3.7%
1/27 • Number of events 1 • Up to one year
|
0.00%
0/4 • Up to one year
|
0.00%
0/27 • Up to one year
|
|
Gastrointestinal disorders
Diarrhea
|
75.0%
3/4 • Number of events 3 • Up to one year
|
92.6%
25/27 • Number of events 25 • Up to one year
|
75.0%
3/4 • Number of events 3 • Up to one year
|
92.6%
25/27 • Number of events 25 • Up to one year
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • Up to one year
|
0.00%
0/27 • Up to one year
|
0.00%
0/4 • Up to one year
|
3.7%
1/27 • Number of events 1 • Up to one year
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • Up to one year
|
7.4%
2/27 • Number of events 2 • Up to one year
|
25.0%
1/4 • Number of events 1 • Up to one year
|
11.1%
3/27 • Number of events 3 • Up to one year
|
|
Cardiac disorders
Dysrhythmia
|
0.00%
0/4 • Up to one year
|
3.7%
1/27 • Number of events 1 • Up to one year
|
0.00%
0/4 • Up to one year
|
3.7%
1/27 • Number of events 1 • Up to one year
|
|
General disorders
Edema
|
0.00%
0/4 • Up to one year
|
3.7%
1/27 • Number of events 1 • Up to one year
|
0.00%
0/4 • Up to one year
|
0.00%
0/27 • Up to one year
|
|
Immune system disorders
Engraftment syndrome
|
0.00%
0/4 • Up to one year
|
3.7%
1/27 • Number of events 1 • Up to one year
|
0.00%
0/4 • Up to one year
|
3.7%
1/27 • Number of events 1 • Up to one year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
25.0%
1/4 • Number of events 1 • Up to one year
|
33.3%
9/27 • Number of events 9 • Up to one year
|
25.0%
1/4 • Number of events 1 • Up to one year
|
48.1%
13/27 • Number of events 13 • Up to one year
|
|
General disorders
Fever
|
0.00%
0/4 • Up to one year
|
0.00%
0/27 • Up to one year
|
0.00%
0/4 • Up to one year
|
7.4%
2/27 • Number of events 2 • Up to one year
|
|
General disorders
Fluid overload
|
0.00%
0/4 • Up to one year
|
3.7%
1/27 • Number of events 1 • Up to one year
|
0.00%
0/4 • Up to one year
|
3.7%
1/27 • Number of events 1 • Up to one year
|
|
Infections and infestations
Fungal
|
0.00%
0/4 • Up to one year
|
3.7%
1/27 • Number of events 1 • Up to one year
|
0.00%
0/4 • Up to one year
|
3.7%
1/27 • Number of events 1 • Up to one year
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/4 • Up to one year
|
3.7%
1/27 • Number of events 1 • Up to one year
|
0.00%
0/4 • Up to one year
|
3.7%
1/27 • Number of events 1 • Up to one year
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/4 • Up to one year
|
3.7%
1/27 • Number of events 1 • Up to one year
|
0.00%
0/4 • Up to one year
|
0.00%
0/27 • Up to one year
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Up to one year
|
3.7%
1/27 • Number of events 1 • Up to one year
|
25.0%
1/4 • Number of events 1 • Up to one year
|
14.8%
4/27 • Number of events 4 • Up to one year
|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • Number of events 3 • Up to one year
|
100.0%
27/27 • Number of events 27 • Up to one year
|
100.0%
4/4 • Number of events 4 • Up to one year
|
100.0%
27/27 • Number of events 27 • Up to one year
|
|
Gastrointestinal disorders
Oral mucositis
|
50.0%
2/4 • Number of events 2 • Up to one year
|
63.0%
17/27 • Number of events 17 • Up to one year
|
75.0%
3/4 • Number of events 3 • Up to one year
|
48.1%
13/27 • Number of events 13 • Up to one year
|
|
Nervous system disorders
Peripheral neuropathy
|
0.00%
0/4 • Up to one year
|
3.7%
1/27 • Number of events 1 • Up to one year
|
0.00%
0/4 • Up to one year
|
0.00%
0/27 • Up to one year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • Up to one year
|
11.1%
3/27 • Number of events 3 • Up to one year
|
0.00%
0/4 • Up to one year
|
11.1%
3/27 • Number of events 3 • Up to one year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/4 • Up to one year
|
7.4%
2/27 • Number of events 2 • Up to one year
|
0.00%
0/4 • Up to one year
|
0.00%
0/27 • Up to one year
|
|
Skin and subcutaneous tissue disorders
Rash
|
75.0%
3/4 • Number of events 3 • Up to one year
|
0.00%
0/27 • Up to one year
|
25.0%
1/4 • Number of events 1 • Up to one year
|
0.00%
0/27 • Up to one year
|
|
Investigations
T bilirubin increased
|
0.00%
0/4 • Up to one year
|
3.7%
1/27 • Number of events 1 • Up to one year
|
25.0%
1/4 • Number of events 1 • Up to one year
|
3.7%
1/27 • Number of events 1 • Up to one year
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/4 • Up to one year
|
3.7%
1/27 • Number of events 1 • Up to one year
|
0.00%
0/4 • Up to one year
|
0.00%
0/27 • Up to one year
|
|
Infections and infestations
Viral
|
0.00%
0/4 • Up to one year
|
3.7%
1/27 • Number of events 1 • Up to one year
|
0.00%
0/4 • Up to one year
|
18.5%
5/27 • Number of events 5 • Up to one year
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Up to one year
|
3.7%
1/27 • Number of events 1 • Up to one year
|
25.0%
1/4 • Number of events 1 • Up to one year
|
0.00%
0/27 • Up to one year
|
Additional Information
Qaiser Bashir, MD / Stem Cell Transplantation
The University of Texas MD Anderson Cancer Center
Phone: 713-794-4422
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place