Lymphodepleting Total Body Irradiation (TBI) Plus Cyclophosphamide Prior to Ciltacabtagene Autoleucel (Carvykti; Cilta-cel) for Multiple Myeloma (MM) Patients With Impaired Renal Function

Inclusion Criteria:

• Histologically confirmed diagnosis of multiple myeloma.

• Renal insufficiency, defined as eGFR < 45 by MDRD formula.

• At least 18 years of age.

• ECOG performance status ≤ 1.

• Meets standard of care indication for cilta-cel (per FDA approval).

• Women of childbearing potential and men must agree to use adequate contraceptionprior to study entry and for the duration of study participation. Should a womanbecome pregnant or suspect she is pregnant while participating in this study orshould a man suspect he has fathered a child, s/he must inform her treatingphysician immediately.

• Ability to understand and willingness to sign an IRB approved written informedconsent document. Legally authorized representatives may sign and give informedconsent on behalf of study participants.

Exclusion Criteria:

• Prior or concurrent malignancy whose natural history has the potential to interferewith the safety or efficacy assessment of the investigational regimen. Patients withprior or concurrent malignancy that does NOT meet that definition are eligible forthis trial.

• Currently receiving any other investigational agents.

• Uncontrolled intercurrent illness including, but not limited to: ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, orunstable cardiac arrhythmia. Patients with a known history or current symptoms ofcardiac disease, or history of treatment with cardiotoxic agents, should have aclinical risk assessment of cardiac function using the New York Heart AssociationFunction Classification; to be eligible for this trial, patients should be a class 2B or better.

• Pregnant and/or breastfeeding. Women of childbearing potential must have a negativepregnancy test within 14 days of study entry.

• HIV-infected if not on effective anti-retroviral therapy with undetectable viralload for 6 months. Patients with HIV who are receiving effective anti-retroviraltherapy and have had an undetectable viral load for at least 6 months are eligible.

• Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressivetherapy. Patients with evidence of chronic HBV infection with undetectable HBV viralload on suppressive therapy are eligible.

• History of hepatitis C virus (HCV) infection that has not been cured or that has adetectable viral load. Patients with a history of HCV that has been treated andcured are eligible. Patients with HCV infection who are currently on treatment andhave an undetectable HCV viral load are eligible.