A Study to Evaluate the Safety of bb2121 in Subjects With High Risk, Newly Diagnosed Multiple Myeloma (NDMM) (KarMMa-4)

Overview

About this study

The purpose of this study is to evaluate the safety and to determine the optimal dose of bb2121 in subjects with high risk, (HR) newly -diagnosed multiple myeloma (NDMM).

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:

  • Subject is newly diagnosed and has symptomatic Multiple Myeloma (MM) prior to initiating induction anti-myeloma therapy.
  • Subject is ≥ 18 years of age at the time of initial diagnosis of Multiple Myeloma (MM).
  • Subject has measurable disease at initial diagnosis by -M-protein and/or -Light chain Multiple Myeloma (MM) without measurable disease in the serum or urine.
  • Subject has high-risk MM at the time of initial diagnosis of Multiple Myeloma (MM) per R-ISS Stage III as defined by IMWG:
    • ISS Stage III and cytogenetic abnormalities with t(4; 14) and/or del(17p) and/or t(14:16) by iFISH; or
    • ISS Stage III and serum LDH > ULN.
  • Subject has Eastern Cooperative Oncology Group performance ≤ 1.
  • Subjects has received ≤ to 3 cycles of the following induction anti-myeloma therapy prior to enrollment:
    • Cycle 1: one of the following regimens (RVd, KRd, CyBorD, D-RVd and D-KRd);
    • Cycle 2 to Cycle 3: either KRd or RVd (Cycle 3 must be without dexamethasone). 

Exclusion Criteria:

  • Subject has non-secretory Multiple Myeloma (MM) during Screening.
  • Subject received any treatments for Multiple Myeloma (MM) other than up to 3 cycles of induction therapy per protocol.
  • Subject has any of the following laboratory abnormalities:
    • Absolute neutrophil count < 1,000/μL;
    • Platelet count < 50,000 mm^3;
    • Hemoglobin < 8 g/dL (< 4.9 mmol/L);
    • Serum creatinine clearance < 45 mL/min;
    • Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L);
    • Serum aspartate aminotransferase or alanine aminotransferase > 2.5 × upper limit of normal;
    • Serum total bilirubin > 1.5 × ULN or > 3.0 mg/dL for subjects with documented Gilbert's syndrome;
    • INR or aPTT > 1.5 × ULN.
  • Subject has history or presence of clinically significant central nervous system (CNS) pathology.
  • Subjects has high risk for developing deep vein thrombosis or pulmonary embolus and are unable or unwilling to undergo anti-thrombotic therapy.
  • Subject has peripheral neuropathy of > Grade 2 severity according to the National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Version 4.03 with bortezomib based induction regimen.
  • Subjects has moderate or severe pulmonary hypertension.
  • Subject has intolerance to components of induction regimen (KRd or RVd) or has any contraindication to one or the other drug.
  • Subject has not recovered from induction therapy-related toxicities (non-hematologic) to < grade 1 CTCAE at the time of screening.
  • Subject has prior history of deep vein thrombosis or pulmonary embolus (PE) within 6 months of starting study treatment.
  • Subject has cardiac conditions such as:
    • Echocardiogram or multi gated acquisition assessment of left ventricular ejection fraction < 45%;
    • Subject has a history of clinically significant cardiovascular disease or clinically significant electrocardiogram (ECG) abnormalities.
  • Subject has Pulmonary conditions such as:
    • Subject has known chronic obstructive pulmonary with a forced expiratory vol in 1 sec 50% of predicted normal;
    • Inadequate pulmonary function defined as oxygen saturation < 92 % on room air.
  • Subject needs ongoing treatment with chronic immunosuppressants.
  • Subject has history of primary immunodeficiency.
  • Subject is seropositive for human immunodeficiency virus, chronic or active hepatitis B or active hepatitis A or C.

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

Peter Bergsagel, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

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Jacksonville, Fla.

Mayo Clinic principal investigator

Sikander Ailawadhi, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

-

More information

Publications

Publications are currently not available
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CLS-20486467

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