Status:
COMPLETED
Pembrolizumab and Radiation Therapy in Patients With Relapsed or Refractory Multiple Myeloma
Lead Sponsor:
Emory University
Collaborating Sponsors:
Merck Sharp & Dohme LLC
National Cancer Institute (NCI)
Conditions:
ISS Stage I Plasma Cell Myeloma
ISS Stage II Plasma Cell Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This pilot clinical trial studies the side effects of pembrolizumab and radiation therapy in treating patients with stage I-III multiple myeloma that has come back after a period of improvement or tha...
Detailed Description
PRIMARY OBJECTIVE: 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. S...
Eligibility Criteria
Inclusion
- International Staging System (ISS) stage I-III multiple myeloma that has progressive, relapsed, or refractory disease
- Able to give informed consent
- Eastern Cooperative Oncology Group (ECOG) 0-1
- Relapsed and/or refractory myeloma; there is no minimum or maximum number of previous therapies that a patient may have received previously before being put on the current trial
- ≥ 1 osseous and/or extra-osseous lesion that can be radiated
- Candidate for pembrolizumab (as determined by physician, and adequate organ function)
- Candidate for radiotherapy (as determined by treatment physician); these patients can have symptomatic disease and/or asymptomatic disease; a minimum of one site of radiation is required to any osseous and/or any extra-osseous disease; radiation to any bony parts of the head and neck, skull, spine, ribs, and/or extremities are allowed; radiation to any bony part for documented lytic disease is allowed; radiation to any soft tissue plasmacytoma (including osseous and extra-osseous plasmacytoma) is allowed; the only exclusion criteria for radiation, is central nervous system (CNS) metastases
- Measurable myeloma disease (urine protein \> 200 mg in 24 hours \[hr\] urine collection, serum free light chain ratio \> 100 with an abnormal k/l ratio, serum M protein \> 0.5 g/dl); 12 of the 24 patients do not have to have measurable disease
- Negative urine pregnancy test within 2 weeks for female subjects; female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication; subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year
- Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
- Abstinence is acceptable, if this is the usual life style and preferred contraception for the patient
Exclusion
- Previous anti-programmed cell death protein 1 (PD1) or anti-PD-L1
- Solitary plasmacytoma
- Smoldering (asymptomatic) multiple myeloma
- Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment
- Has a diagnosis of immunodeficiency
- Known history of active TB (Bacillus tuberculosis)
- Hypersensitivity to pembrolizumab or any of its recipients
- Known additional malignancy that is progressing or requires active treatment (exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin)
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
- Known history of, or any evidence of active, non-infectious pneumonitis
- Active infection requiring systemic therapy
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment
- Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
- Has known active hepatitis B (e.g., hepatitis B surface antigen \[HBsAg\] reactive) or hepatitis C (e.g., hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] \[qualitative\] is detected)
- Has received a live vaccine within 30 days of planned start of study therapy; NOTE: seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed
- Patients requiring radiation for CNS diseases are excluded (CNS defined as brain soft tissue/intra parenchymal metastases within the gray and white matter of the brain and/or for cerebrospinal fluid \[CSF\] disseminated disease, including leptomeningeal carcinomatous disease)
- Has a history of allogeneic stem cell transplantation
Key Trial Info
Start Date :
May 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 2 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03267888
Start Date
May 29 2018
End Date
September 2 2022
Last Update
September 4 2024
Active Locations (1)
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1
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States, 30322