Trial Outcomes & Findings for Melphalan, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon Alfa in Treating Patients With Advanced Multiple Myeloma (NCT NCT00006244)
NCT ID: NCT00006244
Last Updated: 2017-07-12
Results Overview
Overall survival in Multiple Myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2 and interferon maintenance.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
12.9 Median Years
Results posted on
2017-07-12
Participant Flow
Participant milestones
| Measure |
Immunotherapy Treatment
Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.
melphalan: Given IV
recombinant interferon alfa: Given SC
aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Melphalan, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon Alfa in Treating Patients With Advanced Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Immunotherapy Treatment
n=36 Participants
Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.
melphalan: Given IV
recombinant interferon alfa: Given SC
aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
53.56 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12.9 Median YearsOverall survival in Multiple Myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2 and interferon maintenance.
Outcome measures
| Measure |
Immunotherapy Treatment
n=36 Participants
Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.
melphalan: Given IV
recombinant interferon alfa: Given SC
aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
|
|---|---|
|
Overall Survival
|
9 Participants
|
PRIMARY outcome
Timeframe: Evaluated at Day +84-90 Post-TransplantEvaluate initial response to therapy (complete remission, partial remission, stable response, or progression of disease)
Outcome measures
| Measure |
Immunotherapy Treatment
n=36 Participants
Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.
melphalan: Given IV
recombinant interferon alfa: Given SC
aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
|
|---|---|
|
Initial Response to Therapy
Patients in Complete Remission
|
15 Participants
|
|
Initial Response to Therapy
Patients in Partial Remission
|
8 Participants
|
|
Initial Response to Therapy
Patients with Stable resposne
|
10 Participants
|
|
Initial Response to Therapy
Patients with Disease Progression
|
3 Participants
|
PRIMARY outcome
Timeframe: 12.9 years (median)Population: Out of 36 patients, 30 have relapsed and they are used to determine this outcome measure.
Outcome measures
| Measure |
Immunotherapy Treatment
n=30 Participants
Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.
melphalan: Given IV
recombinant interferon alfa: Given SC
aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
|
|---|---|
|
Time to Disease Progression
|
1.61 years
Interval 0.12 to 8.96
|
PRIMARY outcome
Timeframe: 12.9 Median YearsOutcome measures
| Measure |
Immunotherapy Treatment
n=36 Participants
Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.
melphalan: Given IV
recombinant interferon alfa: Given SC
aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
|
|---|---|
|
Proportion of Patients Alive and in Remission
|
4 Participants
|
SECONDARY outcome
Timeframe: First 100 days post-transplantPopulation: Of the 36 patients, 20 patients were \<56 years old and these 20 patients are used to determine this outcome measure.
Grade 3-4 toxicities by the Bearman common toxicity criteria, encountered by younger (\< 56 years old) advanced multiple myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2.
Outcome measures
| Measure |
Immunotherapy Treatment
n=20 Participants
Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.
melphalan: Given IV
recombinant interferon alfa: Given SC
aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
|
|---|---|
|
Number of Patients <56 Years Old Experiencing Grade 3-4 Regimen Related Toxicity
|
1 Participants
|
SECONDARY outcome
Timeframe: First 100 days post-transplantPopulation: Of the 36 patients, 16 patients were ≥56 years old and these 16 are used to determine this outcome measure.
Grade 3-4 toxicities by the Bearman common toxicity criteria, encountered by older (≥56 years old) advanced multiple myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2.
Outcome measures
| Measure |
Immunotherapy Treatment
n=16 Participants
Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.
melphalan: Given IV
recombinant interferon alfa: Given SC
aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
|
|---|---|
|
Number of Patients ≥56 Years Old Experiencing Grade 3-4 Regimen Related Toxicity
|
0 Participants
|
Adverse Events
Immunotherapy Treatment
Serious events: 10 serious events
Other events: 0 other events
Deaths: 27 deaths
Serious adverse events
| Measure |
Immunotherapy Treatment
n=36 participants at risk
Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.
melphalan: Given IV
recombinant interferon alfa: Given SC
aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
|
|---|---|
|
Blood and lymphatic system disorders
Delayed ANC Engraftment
|
2.8%
1/36
|
|
Blood and lymphatic system disorders
Neutropenic fever
|
8.3%
3/36
|
|
General disorders
Fever and GI
|
2.8%
1/36
|
|
Gastrointestinal disorders
Nausea
|
5.6%
2/36
|
|
Cardiac disorders
cardiac event
|
5.6%
2/36
|
|
Immune system disorders
sarcoidosis/failure to thrive
|
2.8%
1/36
|
|
Cardiac disorders
hypotension
|
2.8%
1/36
|
|
Gastrointestinal disorders
mucositis
|
2.8%
1/36
|
|
Gastrointestinal disorders
colitis
|
2.8%
1/36
|
|
Infections and infestations
fever
|
2.8%
1/36
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Leona A. Holmberg
Fred Hutchinson Cancer Research Center
Phone: 206-667-6447
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place