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

Completed · Phase 1

Conditions studied: Multiple Myeloma

In brief

This is a multicenter, open-label, phase 1, single arm study intended to determine the optimal target dose and safety of bb2121 in subjects with HR (R-ISS Stage III per IMWG criteria) NDMM. Subjects should have received 3 Cycles of standard induction therapy prior to undergoing leukapheresis procedure to collect autologous mononuclear cells for manufacture of the drug product (bb2121). Following manufacture of the drug product, subjects will receive fourth cycle of induction therapy followed by lymphodepleting therapy with fludarabine and cyclophosphamide prior to bb2121 infusion. Maintenance therapy is recommended for all subjects who have received bb2121 infusion and should be initiated upon adequate bone marrow recovery or from 90-day post-bb2121 infusion, whichever is later.

Key facts

Study ID

NCT04196491

Run by

Celgene

People needed

13

Starts

2020-05-27

Expected to finish

2023-06-07

Last updated by the study team

2023-08-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must satisfy all of the following criteria to be enrolled in the study:
• 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 MM
• Subject has measurable disease at initial diagnosis by
• M-protein and/or
• Light chain MM without measurable disease in the serum or urine
• Subject has high-risk MM at the time of initial diagnosis of 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)

You may not qualify if…

• The presence of any of the following will exclude a subject from enrollment: The presence of any of the following will exclude a subject from enrollment:
• At initial diagnosis, screening and prior to initiation of induction therapy for MM:
• Subject has non-secretory MM
• During Screening:
• Subject received any treatments for 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 mm3
• 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 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 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 ECG abnormalities
• Subject has Pulmonary conditions such as:

Where it is running

• Local Institution - 119 — Phoenix, Arizona, United States
• Local Institution - 110 — Los Angeles, California, United States
• Local Institution - 116 — San Francisco, California, United States
• Local Institution - 106 — Denver, Colorado, United States
• Local Institution - 101 — Jacksonville, Florida, United States
• Local Institution - 113 — Tampa, Florida, United States
• Local Institution - 108 — Atlanta, Georgia, United States
• Local Institution - 123 — Atlanta, Georgia, United States
• Local Institution - 115 — Boston, Massachusetts, United States
• Local Institution - 122 — Boston, Massachusetts, United States
• Local Institution - 117 — Hackensack, New Jersey, United States
• Local Institution - 121 — New York, New York, United States
• Local Institution - 109 — New York, New York, United States
• Local Institution - 124 — New York, New York, United States
• Local Institution - 120 — Charlotte, North Carolina, United States
• Local Institution - 112 — Portland, Oregon, United States
• Local Institution - 118 — Philadelphia, Pennsylvania, United States
• Local Institution - 103 — Nashville, Tennessee, United States
• Local Institution - 102 — Dallas, Texas, United States
• Local Institution - 114 — Houston, Texas, United States
• Local Institution - 104 — Seattle, Washington, United States
• Local Institution - 107 — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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