Trial Outcomes & Findings for Maintenance Belantamab Mafodotin (Blenrep®) After B-cell Maturation Antigen-Directed Chimeric Antigen Receptor T-cell Therapy in Patients With Relapsed and/or Refractory Multiple Myeloma (NCT NCT05117008)
NCT ID: NCT05117008
Last Updated: 2025-01-28
Results Overview
The primary endpoint of the study is the 12-month progression-free survival (PFS) with time counted from the CAR-T infusion conditional on being alive and progression-free at day +90 post CAR-T. An event will be defined as documented progression or death for any cause, subjects without an event will be censored at the last date known to be alive without progression.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
12 months
Results posted on
2025-01-28
Participant Flow
Participant milestones
| Measure |
Belantamab Mafodotin
Belantamab mafodotin is an intravenous drug.
Belantamab mafodotin: Belantamab mafodotin will be administered IV over approximately 30 minutes at the recommended dose of 2.5 mg/kg IV over 30 minutes on day 1 of every eight-week (+/- three days) cycle for a maximum of 12 cycles. Maintenance therapy with belantamab mafodotin will continue until progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or end of study (maximum of 12 cycles), whichever occurs first.
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|---|---|
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Overall Study
STARTED
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1
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|
Overall Study
COMPLETED
|
1
|
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Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Maintenance Belantamab Mafodotin (Blenrep®) After B-cell Maturation Antigen-Directed Chimeric Antigen Receptor T-cell Therapy in Patients With Relapsed and/or Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Belantamab Mafodotin
n=1 Participants
Belantamab mafodotin is an intravenous drug.
Belantamab mafodotin: Belantamab mafodotin will be administered IV over approximately 30 minutes at the recommended dose of 2.5 mg/kg IV over 30 minutes on day 1 of every eight-week (+/- three days) cycle for a maximum of 12 cycles. Maintenance therapy with belantamab mafodotin will continue until progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or end of study (maximum of 12 cycles), whichever occurs first.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
1 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
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThe primary endpoint of the study is the 12-month progression-free survival (PFS) with time counted from the CAR-T infusion conditional on being alive and progression-free at day +90 post CAR-T. An event will be defined as documented progression or death for any cause, subjects without an event will be censored at the last date known to be alive without progression.
Outcome measures
| Measure |
Belantamab Mafodotin
n=1 Participants
Belantamab mafodotin is an intravenous drug.
Belantamab mafodotin: Belantamab mafodotin will be administered IV over approximately 30 minutes at the recommended dose of 2.5 mg/kg IV over 30 minutes on day 1 of every eight-week (+/- three days) cycle for a maximum of 12 cycles. Maintenance therapy with belantamab mafodotin will continue until progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or end of study (maximum of 12 cycles), whichever occurs first.
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|---|---|
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The Number of Patients With 12-month Progression-free Survival.
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1 Participants
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Adverse Events
Belantamab Mafodotin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Belantamab Mafodotin
n=1 participants at risk
Belantamab mafodotin is an intravenous drug.
Belantamab mafodotin: Belantamab mafodotin will be administered IV over approximately 30 minutes at the recommended dose of 2.5 mg/kg IV over 30 minutes on day 1 of every eight-week (+/- three days) cycle for a maximum of 12 cycles. Maintenance therapy with belantamab mafodotin will continue until progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or end of study (maximum of 12 cycles), whichever occurs first.
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|---|---|
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Musculoskeletal and connective tissue disorders
acquired torsion dystonia
|
100.0%
1/1 • Number of events 1 • 15 months
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
1/1 • Number of events 2 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
100.0%
1/1 • Number of events 1 • 15 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
100.0%
1/1 • Number of events 2 • 15 months
|
|
Eye disorders
Blurred Vision, Right eye
|
100.0%
1/1 • Number of events 1 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Cervical dystonia
|
100.0%
1/1 • Number of events 1 • 15 months
|
|
Investigations
Cholesterol high
|
100.0%
1/1 • Number of events 1 • 15 months
|
|
Skin and subcutaneous tissue disorders
Corn, Left plantat feet
|
100.0%
1/1 • Number of events 1 • 15 months
|
|
Eye disorders
Corneal Stromal scar, both eyes
|
100.0%
1/1 • Number of events 1 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
100.0%
1/1 • Number of events 1 • 15 months
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
1/1 • Number of events 1 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
100.0%
1/1 • Number of events 1 • 15 months
|
|
Eye disorders
Corneal toxicities
|
100.0%
1/1 • Number of events 2 • 15 months
|
|
General disorders
Fever
|
100.0%
1/1 • Number of events 1 • 15 months
|
|
Infections and infestations
Genital Herpes
|
100.0%
1/1 • Number of events 1 • 15 months
|
|
Nervous system disorders
Headache
|
100.0%
1/1 • Number of events 2 • 15 months
|
|
Vascular disorders
Hypertension
|
100.0%
1/1 • Number of events 5 • 15 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
100.0%
1/1 • Number of events 2 • 15 months
|
|
Reproductive system and breast disorders
Infertility
|
100.0%
1/1 • Number of events 1 • 15 months
|
|
General disorders
Knee pain
|
100.0%
1/1 • Number of events 1 • 15 months
|
|
Infections and infestations
Lung Infection
|
100.0%
1/1 • Number of events 1 • 15 months
|
|
Investigations
Lymphocyte count decreased
|
100.0%
1/1 • Number of events 6 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
100.0%
1/1 • Number of events 1 • 15 months
|
|
Investigations
Platelet count decreased
|
100.0%
1/1 • Number of events 2 • 15 months
|
|
Psychiatric disorders
Insomnia
|
100.0%
1/1 • Number of events 1 • 15 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
100.0%
1/1 • Number of events 1 • 15 months
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 1 • 15 months
|
|
Metabolism and nutrition disorders
Anorexia
|
100.0%
1/1 • Number of events 1 • 15 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place