Trial Outcomes & Findings for Pembrolizumab and Radiation Therapy in Patients With Relapsed or Refractory Multiple Myeloma (NCT NCT03267888)

NCT ID: NCT03267888

Last Updated: 2024-09-04

Results Overview

Greater than grade 2 toxicity will be assessed by Common Terminology Criteria for Adverse Events.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 25 participants
• Primary outcome timeframe: Up to 12 months after study start
• Results posted on: 2024-09-04

Participant Flow

Participant milestones

Measure	Radiation Therapy, Pembrolizumab Patients undergo radiation therapy on day 1. Patients also receive pembrolizumab IV over 30 minutes on day 2 or 3. Courses with pembrolizumab repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Pembrolizumab: Given 200 mg/kg IV. Radiation Therapy: Patients will receive radiotherapy (8 Gy/1 fx) to an extra-osseous site and/or any bony site containing myeloma deposit.
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pembrolizumab and Radiation Therapy in Patients With Relapsed or Refractory Multiple Myeloma

Baseline characteristics by cohort

Measure	Radiation Therapy, Pembrolizumab n=25 Participants Patients undergo radiation therapy on day 1. Patients also receive pembrolizumab IV over 30 minutes on day 2 or 3. Courses with pembrolizumab repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Pembrolizumab: Given 200 mg/kg IV. Radiation Therapy: Patients will receive radiotherapy (8 Gy/1 fx) to an extra-osseous site and/or any bony site containing myeloma deposit.
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 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	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	6 Participants n=5 Participants
Race (NIH/OMB) White	19 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	25 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 months after study start

Greater than grade 2 toxicity will be assessed by Common Terminology Criteria for Adverse Events.

Outcome measures

Measure

Radiation Therapy, Pembrolizumab n=25 Participants Patients undergo radiation therapy on day 1. Patients also receive pembrolizumab IV over 30 minutes on day 2 or 3. Courses with pembrolizumab repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Pembrolizumab: Given 200 mg/kg IV. Radiation Therapy: Patients will receive radiotherapy (8 Gy/1 fx) to an extra-osseous site and/or any bony site containing myeloma deposit.

Number of Participants With Adverse Events

8 Participants

SECONDARY outcome

Timeframe: Up to 12 months after study start

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR according to International Myeloma Working Group (IMWG) criteria.

Outcome measures

Measure

Radiation Therapy, Pembrolizumab n=25 Participants Patients undergo radiation therapy on day 1. Patients also receive pembrolizumab IV over 30 minutes on day 2 or 3. Courses with pembrolizumab repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Pembrolizumab: Given 200 mg/kg IV. Radiation Therapy: Patients will receive radiotherapy (8 Gy/1 fx) to an extra-osseous site and/or any bony site containing myeloma deposit.

Number of Patients Achieving Any Response

8 Participants

SECONDARY outcome

Timeframe: Up to 12 months after study start

Will be defined using International IMWG criteria.

Outcome measures

Measure

Radiation Therapy, Pembrolizumab n=25 Participants Patients undergo radiation therapy on day 1. Patients also receive pembrolizumab IV over 30 minutes on day 2 or 3. Courses with pembrolizumab repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Pembrolizumab: Given 200 mg/kg IV. Radiation Therapy: Patients will receive radiotherapy (8 Gy/1 fx) to an extra-osseous site and/or any bony site containing myeloma deposit.

Number of Participants Who Showed an Overall Response to Treatment Based on Baseline Changes on Positron Emission to Positron Emission Tomography/Computed Tomography

20 participants Interval 7.0 to 41.0

SECONDARY outcome

Timeframe: From first treatment on course 1, day 1 to the earlier of date of death and/or last follow up, assessed up to 12 months

Will be estimated using the Kaplan-Meier product-limit method.

Outcome measures

Measure

Radiation Therapy, Pembrolizumab n=25 Participants Patients undergo radiation therapy on day 1. Patients also receive pembrolizumab IV over 30 minutes on day 2 or 3. Courses with pembrolizumab repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Pembrolizumab: Given 200 mg/kg IV. Radiation Therapy: Patients will receive radiotherapy (8 Gy/1 fx) to an extra-osseous site and/or any bony site containing myeloma deposit.

Overall Survival

15 participants

Adverse Events

Radiation Therapy, Pembrolizumab

Serious events: 1 serious events

Other events: 8 other events

Deaths: 10 deaths

Serious adverse events

Measure

Radiation Therapy, Pembrolizumab n=25 participants at risk Patients undergo radiation therapy on day 1. Patients also receive pembrolizumab IV over 30 minutes on day 2 or 3. Courses with pembrolizumab repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Pembrolizumab: Given 200 mg/kg IV. Radiation Therapy: Patients will receive radiotherapy (8 Gy/1 fx) to an extra-osseous site and/or any bony site containing myeloma deposit.

General disorders Fatigue

4.0% 1/25 • Number of events 1 • The first 12 months of treatment

Other adverse events

Measure	Radiation Therapy, Pembrolizumab n=25 participants at risk Patients undergo radiation therapy on day 1. Patients also receive pembrolizumab IV over 30 minutes on day 2 or 3. Courses with pembrolizumab repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Pembrolizumab: Given 200 mg/kg IV. Radiation Therapy: Patients will receive radiotherapy (8 Gy/1 fx) to an extra-osseous site and/or any bony site containing myeloma deposit.
General disorders Fatigue	16.0% 4/25 • Number of events 4 • The first 12 months of treatment
Immune system disorders Fever	8.0% 2/25 • Number of events 2 • The first 12 months of treatment
Musculoskeletal and connective tissue disorders Rigours during infusion	4.0% 1/25 • Number of events 1 • The first 12 months of treatment
Endocrine disorders Hypothyroidism	4.0% 1/25 • Number of events 1 • The first 12 months of treatment

Additional Information

Mohammad K Khan

Emory University

Phone: 404-778-3473

Email: m.k.khan@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place