Multiple Myeloma Clinical Trial

A Safety, PK and Efficacy Study of CC-92480 Monotherapy and in Combination With Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)

Summary

This is an open-label, multi-center, international, Phase 1/2 study to assess the safety, PK and efficacy of CC-92480 monotherapy and in combination with dexamethasone in subjects with relapsed and refractory multiple myeloma (RRMM).

RRMM patient previously treated with at least 3 prior regimens including lenalidomide or pomalidomide, a proteasome inhibitor and a CD38 antibody will be eligible.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.

Subjects must have a documented diagnosis of MM and measurable disease at enrollment. Measurable disease is defined as:

M-protein quantities ≥ 0.5 g/dL by sPEP or
≥ 200 mg/24 hour urine collection by uPEP or
Serum FLC levels > 100 mg/L (milligrams/liter) involved light chain and an abnormal kappa/lambda (κ/λ) ratio in subjects without measurable serum or urine M-protein or
For subjects with immunoglobulin class A (IgA), myeloma whose disease can only be reliably measured by quantitative immunoglobulin measurement, a serum IgA level ≥ 0.50 g/dL.

All subjects must have:

Received at least 3 prior anti-myeloma regimens including at least 2 consecutive cycles of lenalidomide, pomalidomide, a proteasome inhibitor, a glucocorticoid and a CD38 antibody (note: induction with or without bone marrow transplant and with or without maintenance therapy is considered one regimen).

Documented disease progression on or within 60 days from the last dose of their last myeloma therapy

Subjects who had CAR-T therapy as their last myeloma therapy are eligible as long as they have documented disease progression following CAR-T therapy.
In addition to criteria above (a and b), subjects enrolled in Part 2 must have disease refractory to an immunomodulatory agent (lenalidomide and/or pomalidomide), a glucocorticoid, a proteasome inhibitor, and a CD38 antibody. Refractory is defined as disease that is nonresponsive on therapy (failure to achieve minimal response or development of progressive disease), or progresses within 60 days of last dose.

Subjects must have the following laboratory values:

Absolute neutrophil count (ANC) ≥ 1.25 x 109/L without growth factor support for ≥ 7 days (≥ 14 days for pegfilgrastim). ANC of ≥ 1.00 x 109/L is permitted for the dose expansion cohorts (Part 2).
Hemoglobin (Hgb) ≥ 8 g/dL.
Platelets (plt) ≥ 75 x 109/L without transfusion for ≥ 7 days.
Corrected serum calcium ≤ 13.5 mg/dL (≤ 3.4 mmol/L).
Creatinine clearance (CrCl) based on Cockcroft-Gault formula ≥ 45 mL/min.
AST/SGOT and ALT/SGPT ≤ 3.0 x upper limit of normal (ULN).
Serum bilirubin ≤ 1.5 x ULN or < 3.0 mg/dL for subjects with documented Gilbert's syndrome.
Uric acid ≤ 7.5 mg/dL (446 µmol/L).
PT/INR < 1.5 x ULN and partial thromboplastin time (PTT) < 1.5 x ULN, (for subjects not receiving therapeutic anticoagulation).

Females of childbearing potential (FCBP) must:

Have two negative pregnancy tests as verified by the Investigator prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after discontinuation of CC-92480. This applies even if the subject practices true abstinence* from heterosexual contact.
Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with, two reliable forms of contraception as defined in the PPP and provided to the subject at the time of informed consent, without interruption, 28 days prior to starting CC-92480, during the study therapy (including during dose interruptions), and for 28 days after discontinuation of study therapy.

Note: A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point and, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months).

Male subjects must:

Practice true abstinence* (which must be reviewed on a monthly basis) or agree to use of a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study (even during dose interruptions) and for at least 3 months following CC-92480 discontinuation in accordance with the PPP provided to the subject at the time of informed consent, even if he has undergone a successful vasectomy.

* True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and coitus interruptus (withdrawal) are not acceptable methods of contraception.

Males must agree to refrain from donating sperm while on CC-92480 for 90 days after its discontinuation. Females must agree to refrain from donating ova while on CC-92480 for 28 days after its discontinuation.
All subjects must agree to refrain from donating blood while on CC-92480 and for 28 days after its discontinuation.

Exclusion Criteria:

Subject has a significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
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.
Subject has any condition that confounds the ability to interpret data from the study.
Subject has non-secretory multiple myeloma.
Subject has refractory primary multiple myeloma (ie, no history of at least a minor response to a prior treatment regimen).
Subject has plasma cell leukemia or active leptomeningeal myelomatosis.
Subject has documented, systemic light chain amyloidosis or Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes (POEMS) Syndrome.
Subject has immunoglobulin class M (IgM) myeloma.
Part 1: Subject has a history of allogeneic bone marrow transplantation. Part 2: Subject has a history of allogeneic bone marrow transplantation within 6 months prior to first dose. Subject should not have ongoing graft-versus-host disease (GVHD) requiring systemic immunosuppression.
Subject is undergoing dialysis.
Subjects with peripheral neuropathy ≥ Grade 2.
Subjects with gastrointestinal disease that may significantly alter the absorption of CC-92480.

Subject has impaired cardiac function or clinically significant cardiac disease, including any of the following:

LVEF < 45% as determined by ECHO or MUGA scan at Screening.
Complete left bundle branch, bifascicular block or other clinically significant abnormal electrocardiographic (ECG) finding at Screening.
A prolongation of QT interval on Screening ECG as defined by repeated demonstration of a QTc interval >480 milliseconds (ms) using Fridericia's QT correction formula; a history of or current risk factors for Torsades de Pointe (eg, heart failure, hypokalemia, or a family history of Long QT Syndrome); and concurrent administration of medications that prolong the QT/QTc interval.
Congestive heart failure (New York Heart Association Class III or IV).
Myocardial infarction ≤6 months prior to starting CC-92480.
Unstable or poorly controlled angina pectoris, including the Prinzmetal variant of angina pectoris.
Concurrent administration of strong CYP3A modulators; concurrent administration of proton-pump inhibitors (eg, omeprazole, esomeprazole, lansoprazole, pantoprazole) ≤ 2 weeks prior to starting CC-92480.
Subject had prior systemic myeloma treatment with an investigational anti-myeloma agent (eg, anti-PD-1, anti-PD-L1) ≤ 5 half-lives prior to starting CC-92480 (not applicable for subjects who had CAR-T as last prior regimen); subject had prior exposure to approved myeloma therapies (including therapeutic monoclonal antibodies such as anti-CD38 or anti-SLAM-7) ≤ 5 half-lives or within 4 weeks prior to starting CC-92480 whichever is shorter.
Subject had major surgery ≤ 2 weeks prior to starting CC-92480. Note: Subjects must have recovered from any clinically significant effects of recent surgery.
Subject is a pregnant or nursing female, or intends to become pregnant or donate ova during participation in the study.
Subject has known human immunodeficiency virus (HIV) infection.
Subject has known active chronic hepatitis B or C virus (HBV/HCV) infection.
Subject has a history of concurrent second cancer requiring ongoing systemic treatment.

Subjects has a history of prior malignancy other than MM, except if the subject has been free of disease for ≥3 years OR the subject had one of the following noninvasive malignancies treated with curative intent without known recurrence:

Basal or squamous cell carcinoma of the skin.
Carcinoma in situ of the cervix or breast.
Stage 1 bladder cancer.
Incidental histological findings of localized prostate cancer such as tumor stage 1a or 1b (T1a or T1b) using the Tumor/Node/Metastasis (TNM) classification of malignant tumors OR prostate cancer that has been treated with curative intent.
Subject has a history of anaphylaxis to thalidomide, lenalidomide, pomalidomide or dexamethasone.
Subject has known or suspected hypersensitivity to the excipients (excipients include silica dimethyl silylate, anhydrous colloidal silicon dioxide, mannitol, fumaric acid and stearic acid) contained in the formulation of CC-92480 or dexamethasone.

Subject has undergone either of the following within 14 days of initiating CC-92480:

Plasmapheresis.
Radiation therapy other than local therapy for symptomatic relief of MM associated bone lesions.

Subject has received immunosuppressive medication within 14 days prior to the first dose of CC-92480. The following are exceptions to this criterion:

Intranasal, inhaled, topical or local corticosteroid injections (eg, intra-articular injection).
Systemic corticosteroids at doses that do not exceed 10 mg/day of prednisone or the equivalent.
Steroids as premedication for hypersensitivity reactions (eg, computed tomography [CT] scan premedication).
Subject is unable or unwilling to undergo protocol required venous thromboembolism (VTE) prophylaxis.

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

201

Study ID:

NCT03374085

Recruitment Status:

Recruiting

Sponsor:

Celgene

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There are 58 Locations for this study

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City of Hope Cancer Center
Duarte California, 91010, United States
City of Hope Cancer Center
Duarte California, 91010, United States More Info
Scott Goldsmith, Site 103
Contact
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States
Emory Clinic
Atlanta Georgia, 30322, United States
Emory Clinic
Atlanta Georgia, 30322, United States More Info
Sagar Lonial, Site 102
Contact
404-778-1900
Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States More Info
Paul Richardson, Site 105
Contact
617-632-6624
Roswell Park Cancer Center
Buffalo New York, 14263, United States
Roswell Park
Buffalo New York, 14263, United States More Info
Jens Hillengass, Site 111
Contact
716-845-3221
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Malin Hultcrantz, Site 104
Contact
646-608-3714
Allegheny Health Network
Pittsburgh Pennsylvania, 15224, United States More Info
Santhosh Sadashiv, Site 113
Contact
412-578-4484
Gibbs Cancer Center & Research
Spartanburg South Carolina, 29303, United States
Sarah Cannon Cancer Center
Nashville Tennessee, 37203, United States
Sarah Cannon Cancer Center
Nashville Tennessee, 37203, United States More Info
Jesus Berdeja, Site 101
Contact
615-329-0570
MD Anderson Cancer Center The University of Texas
Houston Texas, 77030, United States
MD Anderson Cancer Center The University of Texas
Houston Texas, 77030, United States More Info
Robert Orlowski, Site 106
Contact
713-792-2860
University of Virginia Cancer
Charlottesville Virginia, 22903, United States
University Of Virginia
Charlottesville Virginia, 22908, United States More Info
Laahn Foster, Site 112
Contact
434-982-6517
University of WA School of Medicine
Seattle Washington, 98104, United States
University Of Washington School Of Medicine
Seattle Washington, 98104, United States More Info
Andrew Cowan, Site 109
Contact
Local Institution - 804
Camperdown New South Wales, 2050, Australia More Info
Site 804
Contact
Royal Prince Albert Hospital
Camperdown New South Wales, 2050, Australia
Local Institution - 802
Adelaide South Australia, 5000, Australia More Info
Site 802
Contact
Royal Adelaide Hospital
Adelaide South Australia, 5000, Australia
Local Institution - 805
Clayton Victoria, 3168, Australia More Info
Site 805
Contact
Monash Medical Centre
Clayton Victoria, 3168, Australia
St.Vincent's Hospital Melbourne
Fitzroy Victoria, 3065, Australia
Local Institution - 803
Melbourne Victoria, 3004, Australia More Info
Site 803
Contact
The Alfred Hospital
Melbourne Victoria, 3065, Australia
Local Institution - 806
Fitzroy , 3065, Australia More Info
Site 806
Contact
CHU Mont-Godinne
Yvoir Namur, 5530, Belgium
UZ Gent
Gent Oost-Vlaanderen, 9000, Belgium
UZ Leuven
Leuven Wallon, 3000, Belgium
Local Institution - 904
Antwerpen , 2060, Belgium More Info
Site 904
Contact
UZ Leuven
Antwerpen , 2060, Belgium
Local Institution - 905
Gent , 9000, Belgium More Info
Site 905
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Local Institution - 901
Leuven , 3000, Belgium More Info
Site 901
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Local Institution - 902
Yvoir , 5530, Belgium More Info
Site 902
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Local Institution - 201
Calgary Alberta, T2N 4, Canada More Info
Site 201
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Tom Baker Cancer Center
Calgary Alberta, T2N 4, Canada
Local Institution - 204
London Ontario, N6C 6, Canada More Info
Site 204
Contact
London Health Sciences Centre
London Ontario, N6C 6, Canada
Local Institution - 205
Ottawa Ontario, K1H 8, Canada More Info
Site 205
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Ottawa General Hospital
Ottawa Ontario, K1H 8, Canada
Local Institution - 202
Toronto Ontario, M5G 2, Canada More Info
Site 202
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Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Local Institution - 206
Montreal Quebec, H4A 3, Canada More Info
Site 206
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McGill
Montreal Quebec, H4A 3, Canada
CHUQ
Quebec , G1R 2, Canada
Local Institution - 203
Quebec , G1R 2, Canada More Info
Site 203
Contact
Odense University Hospital
Odense Syddanmark, 5000, Denmark
Local Institution - 503
Aarhus N , DK-82, Denmark More Info
Site 503
Contact
Local Institution - 501
Copenhagen , 2100, Denmark More Info
Site 501
Contact
Rigshospitalet University Hospital
Copenhagen , 2100, Denmark
Local Institution - 502
Odense , 5000, Denmark More Info
Site 502
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Helsinki University Hospital
Helsinki , 00029, Finland
Local Institution - 601
Helsinki , 00029, Finland More Info
Site 601
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Local Institution - 001
Athens , 11528, Greece More Info
Site 001
Contact
Kobe City Medical Center
Kobe Hyogo, 650-0, Japan
Local Institution - 705
Chuo-ku,chiba , 260-8, Japan More Info
Site 705
Contact
Kyushu Medical Center
Fukuoka , 810-8, Japan
Local Institution - 704
Kashiwa , 277-8, Japan More Info
Site 704
Contact
Local Institution - 701
Okayama , 701-1, Japan More Info
Site 701
Contact
Okayama Medical Center
Okayama , 701-1, Japan
Seoul National University Hospital
Seoul Gyeonggido, 03080, Korea, Republic of
Severance Hospital
Seoul Gyeonggido, 03722, Korea, Republic of
Local Institution - 150
Seoul , 135-7, Korea, Republic of More Info
Site 150
Contact
Local Institution - 151
Seoul , 3080, Korea, Republic of More Info
Site 151
Contact
Hospital Universitario Marques
Santander Cantabria, 39008, Spain
Hospital Quironsalud Madrid
Madrid Comunidad De Madrid, 28223, Spain
Hospital Universitari Germans Trias i Pujol Can Ruti
Badalona (Barcelona) , 08916, Spain
Local Institution - 403
Badalona (Barcelona) , 08916, Spain More Info
Site 403
Contact
Local Institution - 407
Barcelona , 08025, Spain More Info
Site 407
Contact
Hospital San Pau
Barcelona , 8025, Spain
Hospital San Pedro de Alcantara
Caceres , 10003, Spain
Local Institution - 406
Caceres , 10003, Spain More Info
Site 406
Contact
Hospital 12 de Octobre
Madrid , 28041, Spain
Local Institution - 404
Madrid , 28041, Spain More Info
Site 404
Contact
Clínica Universidad de Navarra
Pamplona , 31008, Spain
Local Institution - 401
Pamplona , 31008, Spain More Info
Site 401
Contact
Hospital Universitario de Salamanca
Salamanca , 37007, Spain
Local Institution - 402
Salamanca , 37007, Spain More Info
Site 402
Contact
Hospital Universitario La Fe
Valencia , 46026, Spain
Local Institution - 405
Valencia , 46026, Spain More Info
Site 405
Contact
Local Institution - 304
Plymouth Devon, PL6 8, United Kingdom More Info
Site 304
Contact
University Hospital of Wales
Cardiff Wales, CF14 , United Kingdom
Local Institution - 306
Cardiff , CF14 , United Kingdom More Info
Site 306
Contact
Local Institution - 303
London , NW1 2, United Kingdom More Info
Site 303
Contact
University College London Hospitals Cancer Clinical Trials Unitist FloorCentral wing
London , NW1 2, United Kingdom
Local Institution - 305
Newcastle Upon Tyne , NE7 7, United Kingdom More Info
Site 305
Contact
Oxford University Hospitals NHS Trust- Churchill Hospital-Oxford Centre for Respiratory Medicine
Oxford , 0X3 7, United Kingdom
Local Institution - 302
Oxford , OX3 7, United Kingdom More Info
Site 302
Contact
Local Institution - 301
Sutton , SM2 5, United Kingdom More Info
Site 301
Contact
The Royal Marsden NHS Foundation Trust
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

201

Study ID:

NCT03374085

Recruitment Status:

Recruiting

Sponsor:


Celgene

How clear is this clinincal trial information?

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