A Study of JNJ‐68284528 Out‐of‐Specification (OOS) for Commercial Release in Patients with Multiple Myeloma

Overview

About this study

The purpose of this study is to evaluate the effectiveness of cilta-cel OOS based on overall response of partial response (PR) or better (overall response rate, ORR) to treat multiple myeloma.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Yi Lin, M.D., Ph.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
.
CLS-20532048

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