A Study to Compare the Effectiveness and Safety of bb2121 Versus Standard Regimens in Subjects with Relapsed and Refractory Multiple Myeloma (RRMM)

Overview

About this study

The purpose of this study is to compare the effectiveness and safety of bb2121 versus standard regimens in subjects with relapsed and refractory multiple myeloma (RRMM).

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. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria:

  • Subjects must satisfy the following criteria to be enrolled in the study:
    • Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
    • Subject has documented diagnosis of MM and measurable disease
    • Subject has received at least 2 but no greater than 4 prior MM regimens.
    • Subject has received prior treatment with DARA, a proteasome inhibitor and an immunomodulatory compound-containing regimen for at least 2 consecutive cycles.
    • Subject must be refractory to the last treatment regimen. Refractory is defined as documented progressive disease during or within 60 days (measured from the last dose of any drug within the regimen) of completing treatment with the last anti-myeloma regimen before study entry.
    • Subject achieved a response (minimal response [MR] or better) to at least 1 prior treatment regimen.
    • Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    • Recovery to Grade 1 or baseline of any non-hematologic toxicities due to prior treatments, excluding alopecia and Grade 2 peripheral neuropathy.

Exclusion Criteria:

  • Subject has nonsecretory multiple myeloma (MM). 
  • Subject has inadequate pulmonary function defined as oxygen saturation (SaO2) < 92% on room air. 
  • Subject has prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years. 
  • Subject has active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome or amyloidosis. 
  • Subject with known central nervous system (CNS) involvement with myeloma. 
  • Subject has clinical evidence of pulmonary leukostasis and disseminated intravascular coagulation. 
  • Subject has known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) 50% of predicted normal. 
  • Subject has a history or presence of clinically relevant CNS pathology. 
  • Subject was treated with DARA in combination with POM with or without dex (DP±d) as part of their most recent anti-myeloma treatment regimen, cannot receive DPd as bridging therapy but may receive DVd or IRd as bridging as per Investigator's discretion if randomized to Treatment Arm A. 
  • Subject was treated with DP±d as part of their most recent anti-myeloma treatment regimen, cannot receive DPd if randomized to Treatment Arm B but may receive DVd or IRd as per Investigator's discretion. 
  • Subject was treated with DARA in combination with BTZ with or without dex (DV±d) as part of their most recent anti-myeloma treatment regimen, cannot receive DVd as bridging therapy but may receive DPd or IRd as bridging as per Investigator's discretion if randomized to Treatment Arm A. 
  • Subject was treated with DV±d as part of their most recent anti-myeloma treatment regimen, cannot receive DVd if randomized to Treatment Arm B but may receive DPd or IRd as per Investigator's discretion. 
  • Subject was treated with IXA in combination with LEN with or without dex (IR±d) as part of their most recent anti-myeloma treatment regimen, cannot receive IRd as bridging therapy but may receive DPd or DVd as bridging as per Investigator's discretion if randomized to Treatment Arm A. 

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

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Jeremy Larsen, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Sikander Ailawadhi, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

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

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20467300

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