Trial Outcomes & Findings for Dendritic Cell (DC)/Myeloma Fusions in Combination With Nivolumab in Patients With Relapsed Multiple Myeloma (NCT NCT03782064)
NCT ID: NCT03782064
Last Updated: 2023-06-22
Results Overview
We planned to evaluate the immunologic response to treatment in blood and bone marrow. Two patients were treated on protocol and both came off due to disease progression early in the course of therapy (one patient during cycle 1 and one patient during cycle 3.) As such, there is insufficient data to perform what had been planned in correlative science studies so no samples were analyzed. This study has been stopped and no further patients are being enrolled and no further samples are being collected. No data has been obtained for any immune analysis; therefore no immune or clinical data will be reported on this trial.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
2 years
Results posted on
2023-06-22
Participant Flow
Participant milestones
| Measure |
Nivolumab+DC/Myeloma Fusions/GM-CSF
* Nivolumab will be given every two weeks
* The DC/myeloma fusion vaccine/GM-CSF is administered 4 days per cycle
Nivolumab: Nivolumab is a monoclonal antibody. Antibodies are part of your immune system; they are a type of protein that protects your body against foreign invaders, called antigens, by grabbing hold of antigens to stop them from invading your system. Nivolumab has been shown to react against cancer cells, including MM cells.
DC/myeloma fusions/GM-CSF: The DC/MM vaccine is an investigational agent that tries to help the immune system recognize and fight against cancer cells, utilizing unique markers.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
Initiated Treatment
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Nivolumab+DC/Myeloma Fusions/GM-CSF
* Nivolumab will be given every two weeks
* The DC/myeloma fusion vaccine/GM-CSF is administered 4 days per cycle
Nivolumab: Nivolumab is a monoclonal antibody. Antibodies are part of your immune system; they are a type of protein that protects your body against foreign invaders, called antigens, by grabbing hold of antigens to stop them from invading your system. Nivolumab has been shown to react against cancer cells, including MM cells.
DC/myeloma fusions/GM-CSF: The DC/MM vaccine is an investigational agent that tries to help the immune system recognize and fight against cancer cells, utilizing unique markers.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Progression Prior to Starting Treatment
|
3
|
Baseline Characteristics
Dendritic Cell (DC)/Myeloma Fusions in Combination With Nivolumab in Patients With Relapsed Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Nivolumab+DC/Myeloma Fusions/GM-CSF
n=2 Participants
* Nivolumab will be given every two weeks
* The DC/myeloma fusion vaccine/GM-CSF is administered 4 days per cycle
Nivolumab: Nivolumab is a monoclonal antibody. Antibodies are part of your immune system; they are a type of protein that protects your body against foreign invaders, called antigens, by grabbing hold of antigens to stop them from invading your system. Nivolumab has been shown to react against cancer cells, including MM cells.
DC/myeloma fusions/GM-CSF: The DC/MM vaccine is an investigational agent that tries to help the immune system recognize and fight against cancer cells, utilizing unique markers.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
|
Age, Continuous
|
75 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Two patients were treated on protocol and both came off due to disease progression early in the course of therapy. Both participants did not achieve a defined clinical response. There is insufficient data to perform what had been planned in correlative science studies or in immune analysis. This study has been stopped and no further patients are being enrolled and no further samples are being collected.
We planned to evaluate the immunologic response to treatment in blood and bone marrow. Two patients were treated on protocol and both came off due to disease progression early in the course of therapy (one patient during cycle 1 and one patient during cycle 3.) As such, there is insufficient data to perform what had been planned in correlative science studies so no samples were analyzed. This study has been stopped and no further patients are being enrolled and no further samples are being collected. No data has been obtained for any immune analysis; therefore no immune or clinical data will be reported on this trial.
Outcome measures
| Measure |
Nivolumab+DC/Myeloma Fusions/GM-CSF
n=2 Participants
* Nivolumab will be given every two weeks
* The DC/myeloma fusion vaccine/GM-CSF is administered 4 days per cycle
Nivolumab: Nivolumab is a monoclonal antibody. Antibodies are part of your immune system; they are a type of protein that protects your body against foreign invaders, called antigens, by grabbing hold of antigens to stop them from invading your system. Nivolumab has been shown to react against cancer cells, including MM cells.
DC/myeloma fusions/GM-CSF: The DC/MM vaccine is an investigational agent that tries to help the immune system recognize and fight against cancer cells, utilizing unique markers.
|
|---|---|
|
Number of Patients Who Develop Immunologic Response to Nivolumab and the DC/MM Fusion Vaccine
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Number of patients who achieved a clinical response
We looked at the two patients who were treated and evaluated their response to treatment.
Outcome measures
| Measure |
Nivolumab+DC/Myeloma Fusions/GM-CSF
n=2 Participants
* Nivolumab will be given every two weeks
* The DC/myeloma fusion vaccine/GM-CSF is administered 4 days per cycle
Nivolumab: Nivolumab is a monoclonal antibody. Antibodies are part of your immune system; they are a type of protein that protects your body against foreign invaders, called antigens, by grabbing hold of antigens to stop them from invading your system. Nivolumab has been shown to react against cancer cells, including MM cells.
DC/myeloma fusions/GM-CSF: The DC/MM vaccine is an investigational agent that tries to help the immune system recognize and fight against cancer cells, utilizing unique markers.
|
|---|---|
|
Number of Patients Who Achieve a Clinical Response (SD, PR, VGPR, CR)
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Patients who developed treatment-related adverse events
We evaluated the number of patients who developed a related adverse event as assessed by the CTCAE version 4.0.
Outcome measures
| Measure |
Nivolumab+DC/Myeloma Fusions/GM-CSF
n=2 Participants
* Nivolumab will be given every two weeks
* The DC/myeloma fusion vaccine/GM-CSF is administered 4 days per cycle
Nivolumab: Nivolumab is a monoclonal antibody. Antibodies are part of your immune system; they are a type of protein that protects your body against foreign invaders, called antigens, by grabbing hold of antigens to stop them from invading your system. Nivolumab has been shown to react against cancer cells, including MM cells.
DC/myeloma fusions/GM-CSF: The DC/MM vaccine is an investigational agent that tries to help the immune system recognize and fight against cancer cells, utilizing unique markers.
|
|---|---|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
|
2 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: The number of patients who were alive without progression at 2 years
We calculated the number of patients who were alive without progression at 2 years
Outcome measures
| Measure |
Nivolumab+DC/Myeloma Fusions/GM-CSF
n=2 Participants
* Nivolumab will be given every two weeks
* The DC/myeloma fusion vaccine/GM-CSF is administered 4 days per cycle
Nivolumab: Nivolumab is a monoclonal antibody. Antibodies are part of your immune system; they are a type of protein that protects your body against foreign invaders, called antigens, by grabbing hold of antigens to stop them from invading your system. Nivolumab has been shown to react against cancer cells, including MM cells.
DC/myeloma fusions/GM-CSF: The DC/MM vaccine is an investigational agent that tries to help the immune system recognize and fight against cancer cells, utilizing unique markers.
|
|---|---|
|
Number of Patients Who Are Alive Without Progression at 2 Years
|
0 Participants
|
Adverse Events
Nivolumab+DC/Myeloma Fusions/GM-CSF
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Nivolumab+DC/Myeloma Fusions/GM-CSF
n=2 participants at risk
* Nivolumab will be given every two weeks
* The DC/myeloma fusion vaccine/GM-CSF is administered 4 days per cycle
Nivolumab: Nivolumab is a monoclonal antibody. Antibodies are part of your immune system; they are a type of protein that protects your body against foreign invaders, called antigens, by grabbing hold of antigens to stop them from invading your system. Nivolumab has been shown to react against cancer cells, including MM cells.
DC/myeloma fusions/GM-CSF: The DC/MM vaccine is an investigational agent that tries to help the immune system recognize and fight against cancer cells, utilizing unique markers.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash, maculopapular
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from the first dose of treatment through 30 days after the last dose of treatment up to 6 months. All-Cause Mortality monitored/assessed up to 2 years
|
Other adverse events
| Measure |
Nivolumab+DC/Myeloma Fusions/GM-CSF
n=2 participants at risk
* Nivolumab will be given every two weeks
* The DC/myeloma fusion vaccine/GM-CSF is administered 4 days per cycle
Nivolumab: Nivolumab is a monoclonal antibody. Antibodies are part of your immune system; they are a type of protein that protects your body against foreign invaders, called antigens, by grabbing hold of antigens to stop them from invading your system. Nivolumab has been shown to react against cancer cells, including MM cells.
DC/myeloma fusions/GM-CSF: The DC/MM vaccine is an investigational agent that tries to help the immune system recognize and fight against cancer cells, utilizing unique markers.
|
|---|---|
|
Investigations
Alkaline Phosphatase Increase
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from the first dose of treatment through 30 days after the last dose of treatment up to 6 months. All-Cause Mortality monitored/assessed up to 2 years
|
|
Investigations
GGT increased
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from the first dose of treatment through 30 days after the last dose of treatment up to 6 months. All-Cause Mortality monitored/assessed up to 2 years
|
|
General disorders
Injection Site Reaction
|
100.0%
2/2 • Number of events 2 • Adverse events were collected from the first dose of treatment through 30 days after the last dose of treatment up to 6 months. All-Cause Mortality monitored/assessed up to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from the first dose of treatment through 30 days after the last dose of treatment up to 6 months. All-Cause Mortality monitored/assessed up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness (lower limb)
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from the first dose of treatment through 30 days after the last dose of treatment up to 6 months. All-Cause Mortality monitored/assessed up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain, hip
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from the first dose of treatment through 30 days after the last dose of treatment up to 6 months. All-Cause Mortality monitored/assessed up to 2 years
|
Additional Information
Emma Logan, Director of Research Nursing
Beth Israel Deaconess Medical Center
Phone: 6176675984
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place