Hypofractionation (Radiation) Trial for Multiple Myeloma

Exclusion Criteria

• •1. Target Population
• •• Participants must not have SINS (spinal instability neoplastic score) less than 13 or Mirels' score less than 9 prior to starting radiation treatment
• •• Participants must not receive any concurrent anti-myeloma or systemic therapy of any form.
• •• Participants who have not recovered (i.e. greater than grade 1 or at baseline) from adverse events due to a previously administered agent will be excluded. Participants may receive concurrent steroids.
• •i) Note: subjects with greater than grade 2 neuropathy are an exception to this criterion and may qualify for the study.
• •ii) Note: if subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
• •iii) Note: subjects with any grade alopecia are an exception to this criterion and may qualify for the study • Participants must not have had prior radiation therapy (defined as less than 10 percent of prior prescription dose) to the area planning to be treated with radiation.
• •• Participants who have had prior cytotoxic chemotherapy must not receive that therapy within 2 weeks of the initiation of radiation
• •• Participants who have had prior anti-cancer monoclonal antibody (mAb) or other small molecules must not receive that therapy within 7 days of the initiation of radiation
• •• Participants must not have a known additional malignancy that could confuse analysis of on-study treatment. Inclusion of all study participants with more than one malignancy must be discussed and approved by the PI.
• •* Participants must not have a known history of non-infectious pneumonitis that required steroids for treatment.
• •* Participants must not have evidence of interstitial lung disease.
• •* Participants must not have a current seizure disorder.
• •* Participants must not have a history or current evidence of any condition, therapy or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• •* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• •* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
• •* Participants must not have had uncontrolled or significant cardiovascular disease including, but not limited to, any of the following:
• •* Myocardial infarction or stroke/transient ischemic attack within the past 6 months
• •* Uncontrolled angina within the past 3 months
• •* Any history of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
• •* History of other clinically significant heart disease (e.g. cardiomyopathy, congestive heart failure with New York Heart Association functional classification III to IV, pericarditis, significant pericardial effusion, or myocarditis)
• •* Cardiovascular disease-related requirement for daily supplemental oxygen therapy.
• •* Participants may not concomitantly use statins while on study. However, a patient using statins for over 3 months prior to study drug administration and in stable status without creatine kinase (CK) rise may be permitted to enroll.
• •* Participants may not have current or history of clinically significant muscle disorders (e.g. myositis), recent unresolved muscle injury, or any condition known to elevate serum creatine kinase (CK) levels.
• •* Participants must not be prisoners or be involuntarily incarcerated.
• •* Participants must not be compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
• •Eligibility criteria for this study have been carefully considered to ensure the safety of the study participants and that the results of the study can be used. It is imperative that participants fully meet all eligibility criteria.