NL-OMON54734招募中2 期
A PHASE 1B/2A MULTICENTER, OPEN-LABEL, DOSE-ESCALATION STUDY TO DETERMINE THE MAXIMUM TOLERATED DOSE, ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF CC-220 AS MONOTHERAPY AND IN COMBINATION WITH OTHER TREATMENTS IN SUBJECTS WITH MULTIPLE MYELOMA - Celgene 0451/0204
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subject is >=18 years of age the time of signing the informed consent form
- •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
- •4. All subjects in RRMM cohorts must have a documented diagnosis of MM and have
- •measurable disease defined as a) M-protein (serum and/or urine protein
- •electrophoresis (sPEP or uPEP)): sPEP >=0.5 g/dL or uPEP >=200 mg/24 hours and/or
- •b) Light chain MM without measurable disease in the serum or urine: serum
- •immunoglobulin free light chain >= 10 mg/dL (100 mg/L) and abnormal serum
- •immunoglobulin kappa lambda free light chain ratio
- •5. Subjects in Cohorts A, B, C, E, G1 and G2 must have received at least 2
- •prior myeloma regimens (note: induction with or without bone marrow transplant
- •and with or without maintenance therapy is considered one regimen). Subjects in
- •Cohort F must have received at least 1 prior myeloma regimen. Subjects in
- •Cohorts D and I must have received at least 3 prior myeloma regimens.
- •6. All subjects in RRMM cohorts must have received prior treatment with at
- •least 2 consecutive cycles of a lenalidomide or pomalidomide-containing
- •regimen. Subjects in Cohort D must have received at least 3 prior myeloma
- •7. All subjects in RRMM cohorts must have received prior treatment with at
- •least 2 consecutive cycles of a proteasome inhibitor or a proteasome
- •inhibitor-containing regimen
- •8. For Part 2 RRMM cohorts (Cohorts C, D and I), all subjects must have
- •received prior treatment with at least 2 consecutive cycles of a CD38 antibody
- •or a CD38 antibody-containing regimen
- •9. All subjects in RRMM cohorts must have 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 must have documented disease
- •progression.
- •10. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1
- •11. A female of childbearing potential (FCBP) is a female who: 1) has achieved
- •menarche at some point, 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) and must: a. Have two negative pregnancy tests as verified
- •by the Investigator prior to starting study treatment. She must agree to
- •ongoing pregnancy testing during the course of the study, and after end of
- •study treatment. This applies even if the subject practices true abstinence
- •from heterosexual contact. b. 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 forms of
- •contraception: one highly effective, and one additional effective (barrier)
- •measure of contraception without interruption 28 days prior to starting <br
排除标准
- •1. Subject has any significant medical condition, laboratory abnormality, or
- •psychiatric illness that would prevent the subject from participating in the
- •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
- •4. Subject has nonsecretory multiple myeloma
- •5. Subjects with Plasma Cell leukemia or amyloidosis
- •6. Any of the following laboratory abnormalities · Absolute neutrophil count
- •(ANC) <1,000/µL · Platelet count < 75,000/µL for Part 1. For Part 2; platelet
- •count < 75,000/µL for subjects in whom < 50% of bone marrow nucleated cells are
- •plasma cells; otherwise platelet count < 50,000/µL (transfusions are not
- •permitted to achieve minimum platelet counts) · Corrected serum calcium >13.5
- •mg/dL (>3.4 mmol/L) · Serum glutamic oxaloacetic transaminase (SGOT)/aspartate
- •aminotransferase (AST) or serum glutamic pyruvic transaminase (SGPT)/alanine
- •aminotransferase (ALT) >=2.0 x upper limit of normal (ULN) · Serum total
- •bilirubin and alkaline phosphatase >1.5 x ULN · Subjects with serious renal
- •impairment (creatine clearance [CrCl] <30 mL/min) or requiring dialysis would
- •be excluded
- •7. Subjects with peripheral neuropathy >=Grade 2
- •8. Subjects with gastrointestinal disease that may significantly alter the
- •absorption of CC-220
- •9. Subjects with a 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 noninvasive 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 histological findings of prostate
- •cancer such as T1a or T1b using the Tumor/Node/Metastasis (TNM) classification
- •of malignant tumors or prostate cancer that is curative
- •10. Subject has a history of anaphylaxis or hypersensitivity to thalidomide,
- •lenalidomide, pomalidomide, DEX, daratumumab (for Cohorts E and K), bortezomib
- •(for Cohorts F, J1 and J2), or carfilzomib (for Cohorts G1 and G2). Subject has
- •known or suspected hypersensitivity to the excipients contained in the
- •formulation of CC-220, DEX, daratumumab (for Cohorts E and K), bortezomib (for
- •Cohorts F, J1 and J2) ), or carfilzomib (for Cohorts G1 and G2)
- •11. Contraindications to the other treatment regimens, as per local prescribing
- •information
- •12. Subject has received any of the following within the last 14 days of
- •initiating IP: · Plasmapheresis · Major surgery (as defined by the
- •Investigator) · Radiation therapy other than local therapy for MM associated
- •bone lesions · Use of any systemic myeloma drug therapy
- •13. Subject has been treated with an investigational agent (ie, an agent not
- •commercially available) within 28 days or 5 half-lives (whichever is longer) of
- •initiating IP. Not applicable for subjects who had CAR T as last prior regimen.
- •14. Subject has any one of the following: · Clinically significant
研究者
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