Avelumab in Combination With Hypofractionated Radiotherapy in Patients With Relapsed Refractory Multiple Myeloma

Stopped early · Phase 2

Conditions studied: Myeloma, Multiple, Myeloma-Multiple

In brief

Background: Multiple myeloma is a cancer that forms from plasma cells which normally produce important immune response antibodies. It cannot be cured. Researchers hope the combination of radiation combined with the drug avelumab causes the immune system to kill myeloma cells more effectively. Objective: To see if avelumab given with radiation treatment helps treat multiple myeloma. Also to see if giving the treatments together is safe. Eligibility: People ages 18 and older with multiple myeloma that has come back after treatment and has spread to other parts of the body Design: Participants will be screened with: Medical history Physical exam Blood, urine, and heart tests Possible tumor biopsy Bone marrow testing: A needle will be stuck into the participants hipbone to take out a small amount of marrow. Positron emission tomography (PET)/Computed tomography (CT) scan and magnetic resonance imaging (MRI): Participants will lie in a machine that takes pictures of the body. Participants will get avelumab through an intravenous (IV). An IV is a small plastic tube put into an arm vein. They will get avelumab every 2 weeks for 2 doses. Then they will get radiation each day for 5 days. They will continue to get avelumab every 2 weeks as long as they do not have bad side effects and the treatment is helping their disease. Participants will have blood and urine tests, bone marrow biopsies, scans, and X-rays repeated during the study. Participants will have a follow-up visit 30 days after their last treatment dose. Then they will have visits every 3-6 months for up to 5 years....

Key facts

Study ID: NCT03910439
Run by: National Cancer Institute (NCI)
People needed: 4
Starts: 2019-10-17
Expected to finish: 2020-11-04
Last updated by the study team: 2021-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Patients with clinically unstable lesions (e.g., impending cord compression) where a delay in receiving radiation therapy (XRT) would be detrimental are not eligible
Current or prior anti-cancer treatment prior to the first dose of avelumab as defined below:
Chemotherapy, targeted small molecule therapy, or other anti-cancer treatment not otherwise specified below within 2 weeks
Radiation therapy within 2 weeks
Anti-cancer monoclonal antibody (mAb) treatment within 4 weeks
Use of an investigational agent (e.g., biologic, drug, or other) within 4 weeks
Allogeneic stem cell transplant
No autoimmune disease, as follows:
Active (acute or chronic) autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with type I diabetes, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment may be eligible.
History of serious autoimmune-related disorders including immune colitis, inflammatory bowel disease, pneumonitis, or pulmonary fibrosis whether drug- mediated or not.
Current use of immunosuppressive medication, EXCEPT for the following:
Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection)
Systemic corticosteroids at physiologic doses
Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
Uncontrolled intercurrent illness including, but not limited to the following that may limit interpretation of results or that could increase risk to the patient in the judgment of the investigator:
Patients with a positive hepatitis B core antibody [HBcAb] and negative surface antigen (HBsAg) may be included if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is undetectable
Patients who are positive for hepatitis C virus (HCV) antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible for study participation
Known acquired immunodeficiency syndrome (AIDS). Controlled and stable human immunodeficiency virus (HIV) positivity is allowed
Prior organ transplantation including allogenic stem-cell transplantation
Clinically significant cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (greater than or equal to New York Heart Association Classification Class III), or serious cardiac arrhythmia requiring medication. Mild arrhythmias, e.g. stable atrial fibrillation, may be allowed at the discretion of the investigator
Active infection requiring systemic therapy (minor infections may be allowed at the discretion of the investigator)
Known mental or physical illness that would interfere with cooperation with the requirements of the trial or confound the results or interpretation of the results of the trial and, in the opinion of the treating investigator, would make the patient inappropriate for entry into the study.
Persisting toxicity related to prior therapy (Grade > 1); however, alopecia, sensory neuropathy Grade less than or equal to 2, or other Grade less than or equal to 2 not constituting a safety risk based on investigator s judgment are acceptable.
Vaccination with live vaccines within 4 weeks of the first dose of avelumab and while on study is prohibited (inactivated vaccines may be administered).
Pregnant or lactating females. Because there is an unknown but potential risk for adverse events in nursing infants, on-study breastfeeding is not allowed.

Where it is running

National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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