Pembrolizumab and Radiation Therapy in Patients With Relapsed or Refractory Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT03267888|
Recruitment Status : Recruiting
First Posted : August 30, 2017
Last Update Posted : February 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|ISS Stage I Plasma Cell Myeloma ISS Stage II Plasma Cell Myeloma ISS Stage III Plasma Cell Myeloma Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma||Biological: Pembrolizumab Radiation: Radiation Therapy||Phase 1|
I. To evaluate the safety of concurrent single/low dose radiation therapy (radiotherapy) (8 Gy/1fx) in combination with pembrolizumab in relapsed or refractory myeloma patients.
I. To characterize late toxicity (Common Terminology Criteria for Adverse Events [CTCAE] > grade 2 toxicity at 6 and 12 months) and the effect of radiation in combination with pembrolizumab on systemic response rates using international myeloma working group (IMWG) uniform response criteria for multiple myeloma at 6 months and 12 months.
II. To assess changes in positron emission tomography/computed tomography (PET/CT) as a result of combining pembrolizumab and radiotherapy at 6 months and 12 months.
Patients undergo radiation therapy on day 1. Patients also receive pembrolizumab intravenously (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.
After completion of study treatment, patients are followed up at 30 days and then every 12 weeks thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Pembrolizumab and Single-Fraction, Low-Dose, Radiation Therapy in Patients With Relapsed or Refractory Multiple Myeloma|
|Actual Study Start Date :||May 29, 2018|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||May 31, 2021|
Experimental: 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.
Given 200 mg/kg IV.
Radiation: Radiation Therapy
Patients will receive radiotherapy (8 Gy/1 fx) to an extra-osseous site and/or any bony site containing myeloma deposit.
Other Name: Radiotherapy
- Incidence of adverse events [ Time Frame: Up to 12 months after study start ]Greater than grade 2 toxicity will be assessed by Common Terminology Criteria for Adverse Events. Proportion adverse events will be reported.
- Number of patients achieving any response [ Time Frame: Up to 12 months after study start ]According to International Myeloma Working Group (IMWG) criteria.
- Overall response based on baseline changes on positron emission to positron emission tomography/computed tomography [ Time Frame: Up to 12 months after study start ]Will be defined using International IMWG criteria.
- Overall survival [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03267888
|Contact: Mohammad K. Khan, MD, PhDemail@example.com|
|Contact: Jonathan Kaufman, MDfirstname.lastname@example.org|
|United States, Georgia|
|Emory University/Winship Cancer Institute||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Stacey Worrell 404-778-4206 email@example.com|
|Contact: Giesla Rodgers 404-778-5162 firstname.lastname@example.org|
|Principal Investigator:||Mohammad K. Khan, MD, PhD||Emory University|