Clinical Trials

Inclusion Criteria:

• ≥ 18 years of age.
• Eligible for treatment with cilta-cel per USPI or locally approved label.
• Participant is suffering from serious or life-threatening multiple myeloma per USPI (or locally approved label, respectively), and re-apheresis, re‑manufacturing, or other antimyeloma directed therapies is not considered feasible or adequate per investigator.
•  A favorable participant benefit/risk assessment is concluded following the sponsor’s medical review.
• Has adequate general health status and organ function per investigator assessment and meets the criteria to receive cilta-cel OOS.
• Meets the criteria to receive lymphodepleting chemotherapy.
• A woman of childbearing potential must have a negative highly sensitive serum (β-human chorionic gonadotropin [β-hCG]) pregnancy test at consenting and prior to the first dose of cyclophosphamide and fludarabine.
• A woman using oral contraceptives must use an additional contraceptive method.
• A woman must be:
  • Not of childbearing potential;
  • Of childbearing potential; and
  • Practicing a highly effective method of contraception (failure rate of < 1% per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study treatment and until 1 year after receiving a last dose of cilta-cel OOS infusion. The investigator should evaluate the potential for contraceptive method failure (eg, noncompliance, recently initiated) in relationship to the first dose of study treatment.
• A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 1 year after the last dose of study treatment. (cilta-cel OOS).
• A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 1 year after receiving the last dose of study treatment (cilta-cel OOS).
• Male participants must agree to the following during the intervention period and for at least 1 year after the last dose of study treatment:
  • Who is sexually active with a woman of childbearing potential must agree to use a barrier method of contraception (e.g., condom with spermicidal foam/gel/film/cream/suppository) from the time of signing the ICF until 1 year after the last dose of study treatment (cyclophosphamide, fludarabine [standard-of-care] or cilta-cel OOS, respectively);
  • Who is sexually active with a woman who is pregnant must use a condom
• Must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.

Exclusion Criteria:

• History of active uncontrolled infection or condition where an administration of ciltacel OOS constitutes serious health risk to the participant.
• Known allergies, hypersensitivity, or intolerance to the excipients of cilta-cel OOS including dimethyl sulfoxide (DMSO), dextran 40, or residual kanamycin per USPI (or local approved label).
• Any conditions (listed below) for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
• History of active uncontrolled infection or condition where an administration of ciltacel OOS constitutes serious health risk to the participant 2 Known allergies, hypersensitivity, or intolerance to the excipients of cilta-cel OOS including dimethyl sulfoxide (DMSO), dextran 40, or residual kanamycin per USPI (or local approved label).
• Any conditions (listed below), for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.

Eligibility last updated 12/29/21. Questions regarding updates should be directed to the study team contact.