Multiple Myeloma Clinical Trial

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

Summary

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 treatment-for-multiple-myeloma-induction-therapy/" >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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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:

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

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

13

Study ID:

NCT04196491

Recruitment Status:

Completed

Sponsor:

Celgene

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There are 22 Locations for this study

See Locations Near You

Local Institution - 119
Phoenix Arizona, 85054, United States
Local Institution - 110
Los Angeles California, 90095, United States
Local Institution - 116
San Francisco California, 94143, United States
Local Institution - 106
Denver Colorado, 80218, United States
Local Institution - 101
Jacksonville Florida, 32224, United States
Local Institution - 113
Tampa Florida, 33612, United States
Local Institution - 108
Atlanta Georgia, 30322, United States
Local Institution - 123
Atlanta Georgia, 30342, United States
Local Institution - 115
Boston Massachusetts, 02114, United States
Local Institution - 122
Boston Massachusetts, 02215, United States
Local Institution - 117
Hackensack New Jersey, 07601, United States
Local Institution - 121
New York New York, 10016, United States
Local Institution - 109
New York New York, 10029, United States
Local Institution - 124
New York New York, 10065, United States
Local Institution - 120
Charlotte North Carolina, 28207, United States
Local Institution - 112
Portland Oregon, 97239, United States
Local Institution - 118
Philadelphia Pennsylvania, 19104, United States
Local Institution - 103
Nashville Tennessee, 37203, United States
Local Institution - 102
Dallas Texas, 75390, United States
Local Institution - 114
Houston Texas, 77030, United States
Local Institution - 104
Seattle Washington, 98109, United States
Local Institution - 107
Milwaukee Wisconsin, 53226, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

13

Study ID:

NCT04196491

Recruitment Status:

Completed

Sponsor:


Celgene

How clear is this clinincal trial information?

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