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Clinical Trials/NL-OMON56296
NL-OMON56296RecruitingPhase 3

A Phase 3, Multicenter, Randomized, Open Label Study to Compare the Efficacy and Safety of BB2121 Versus Standard Regimens in Subjects with Relapsed and Refractory Multiple Myeloma (RRMM) (KarMMa-3) - bb2121-MM-003 (0451/0320)

Celgene Corporation0 sites16 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Recruiting
Enrollment
16
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

Inclusion Criteria

  • •1. Subject is >= 18 years of age at the time of signing the informed consent
  • •2. Subject must understand and voluntarily sign an ICF prior to any
  • •study-related assessments/procedures being conducted.
  • •3. Subject is willing and able to adhere to the study visit schedule and other
  • •protocol requirements within this protocol and for a subject randomized to
  • •Treatment Arm A, subject agrees to continued follow-up for up to 15 years as
  • •mandated by the regulatory guidelines for gene therapy trials.
  • •4. Subject has documented diagnosis of MM and measurable disease, defined as:
  • •M-protein (serum protein electrophoresis [sPEP] or urine protein
  • •electrophoresis [uPEP]): sPEP >= 0.5 g/dL or uPEP >= 200 mg/24 hours and/or
  • •Light chain MM without measurable disease in the serum or urine: Serum
  • •immunoglobulin free light chain >= 10 mg/dL and abnormal serum immunoglobulin
  • •kappa lambda free light chain ratio
  • •5. Subject has received at least 2 but no greater than 4 prior MM regimens.
  • •Note: induction with or without hematopoietic stem cell transplant and with or
  • •without maintenance therapy is considered as one regimen.
  • •6. Subject has received prior treatment with DARA, a proteasome inhibitor- and
  • •an immunomodulatory compound-containing regimen for at least 2 consecutive
  • •7. 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.
  • •8. Subject achieved a response (minimal response [MR] or better) to at least 1
  • •prior treatment regimen.
  • •9. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status
  • •of 0 or 1.
  • •10. Recovery to Grade 1 or baseline of any non-hematologic toxicities due to
  • •prior treatments, excluding alopecia and Grade 2 peripheral neuropathy.
  • •11. Adequate vascular access for leukapheresis.
  • •12 and 13. Adequate contraceptive measures as outlined in the protocol.
  • •Refer to protocol for additional inclusion criteria.

Exclusion Criteria

  • •1. Subject has any significant medical condition, laboratory abnormality, or
  • •psychiatric illness that would prevent the subject from participating in the
  • •study. 2. Subject has any condition including the presence of laboratory
  • •abnormalities, which places the subject at unacceptable risk if he/she were to
  • •participate in the study. 3. Subject has any condition that confounds the
  • •ability to interpret data from the study. 4. Subject has nonsecretory MM. 5.
  • •Subject has any of the following laboratory abnormalities: a. Absolute
  • •neutrophil count (ANC) < 1,000/µL b. Platelet count: < 75,000/µL in
  • •subjects in whom < 50% of bone marrow nucleated cells are plasma cells and
  • •platelet count < 50,000/µL in subjects in whom >= 50% of bone marrow
  • •nucleated cells are plasma cells (it is not permissible to transfuse a subject
  • •to reach this level) c. Hemoglobin < 8 g/dL (< 4.9 mmol/L) (it is not
  • •permissible to transfuse a subject to reach this level) d. Serum creatinine
  • •clearance (CrCl) < 45 mL/min e. Corrected serum calcium > 13.5 mg/dL
  • •(> 3.4 mmol/L) f. Serum aspartate aminotransferase (AST) or alanine
  • •aminotransferase (ALT) > 2.5 × upper limit of normal (ULN) g. Serum total
  • •bilirubin > 1.5 × ULN or > 3.0 mg/dL for subjects with documented
  • •Gilbert*s syndrome h. International normalized ratio (INR) or activated partial
  • •thromboplastin time (aPTT) > 1.5 × ULN, or history of Grade >= 2 hemorrhage
  • •within 30 days, or subject requires ongoing treatment with chronic, therapeutic
  • •dosing of anticoagulants (eg, warfarin, low molecular weight heparin, Factor Xa
  • •inhibitors) 6. Subject has inadequate pulmonary function defined as oxygen
  • •saturation (SaO2) < 92% on room air. 7. Subject has prior history of
  • •malignancies, other than MM, unless the subject has been free of the disease
  • •for >= 5 years with the exception of the following non-invasive malignancies: •
  • •Basal cell carcinoma of the skin • Squamous cell carcinoma of the skin •
  • •Carcinoma in situ of the cervix • Carcinoma in situ of the breast • Incidental
  • •histologic finding of prostate cancer (T1a or T1b using the tumor, nodes,
  • •metastasis [TNM] clinical staging system) or prostate cancer that can be
  • •treated with curative intent 8. Subject has active or history of plasma cell
  • •leukemia, Waldenstrom*s macroglobulinemia, POEMS syndrome (polyneuropathy,
  • •organomegaly, endocrinopathy, monoclonal protein, and skin changes) or
  • •amyloidosis. 9. Subject with known central nervous system (CNS) involvement
  • •with myeloma. 10. Subject has clinical evidence of pulmonary leukostasis and
  • •disseminated intravascular coagulation. 11. Subject has known chronic
  • •obstructive pulmonary disease (COPD) with a forced expiratory volume in 1
  • •second (FEV1) 50% of predicted normal. Note that forced expiratory testing
  • •(FEV1) is required for subjects suspected of having COPD and subjects must be
  • •excluded if FEV1 is < 50% of predicted normal. 12. Subject has a history or
  • •presence of clinically relevant CNS pathology such as epilepsy, seizure,
  • •paresis, aphasia, stroke, subarachnoid hemorrhage or other CNS bleed, severe
  • •brain injuries, dementia, Parkinson's disease, cerebellar disease, organic
  • •brain syndrome, or psychosis. 13. Subject was treated with DARA in combination
  • •with POM with or without dexamethasone (DP±d) as part of their most r

Investigators

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