NL-OMON54280招募中3 期
Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects with Relapsed or Refractory Multiple Myeloma (RRMM) - CC-220-MM-002
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 12
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 at the time of signing the informed consent
- •form (ICF).
- •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. Subject has documented diagnosis of MM and measurable disease, defined as
- •a. M-protein quantities >= 1 g/dL by serum protein electrophoresis (sPEP) or >=
- •200 mg/24-hour urine collection by urine protein electrophoresis (uPEP); or
- •b. Light chain MM without measurable disease in serum or urine: serum free
- •light chain (FLC) levels > 100 mg/L (10 mg/dL) involved light chain and an
- •abnormal kappa/lambda FLC ratio
- •5. Subject has received 1 to 2 prior lines of anti-myeloma therapy.
- •6. Subject achieved a response (partial response [PR] or better) to at least 1
- •prior antimyeloma regimen.
- •7. Subject must have documented disease progression during or after their last
- •antimyeloma regimen.
- •8. Prior treatment with CD38-directed therapy:
- •In Stage 1, subjects with prior CD38-directed therapy are not eligible.
- •In Stage 2, prior treatment with CD38-directed therapy is permitted only if all
- •the following are fulfilled:
- •a. Best response achieved during CD38-directed therapy was > PR.
- •b. Subject did not progress while receiving CD38-directed therapy or within 60
- •days of last dose of therapy.
- •c. Subject did not discontinue CD38-directed therapy due to a related AE.
- •d. Last dose of daratumumab was >= 3 months prior to randomization.
- •9. .Prior treatment with bortezomib therapy is permitted, if all the following
- •are fulfilled:
- •a.Best response achieved during bortezomib-containing therapy was at least a
- •minimal response (MR).
- •b.Subject did not progress while receiving bortezomib therapy or within 60 days
- •of last dose of therapy.
- •10.Subject has an Eastern Cooperative Oncology Group (ECOG) performance status
- •score of 0, 1 or 2.
- •11. Females of childbearing potential (FCBP) 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, 2 forms of contraception: one highly effective, and one
- •additional effective (barrier) measure of contraception without interruption 28
- •days prior to starting study treatment, during the study treatment (including
- •dose interruptions), and for at least 28 days after the last dose of
- •iberdomide, 3 months after the last dose of daratumumab or 7 months after the
- •last dose of bortezomib, whichever is longest.
- •12. Male subjects must:
- •a. Practice true abstinence or agree to use a condom during sexual contact
- •with a pregnant female or a female of childbearing potential while
- 另有 3 项未显示
排除标准
- •1. Subject has any significant medical condition, including active or
- •uncontrolled infection, presence of laboratory abnormality, or psychiatric
- •illness that places the subject at an unacceptable risk for treatment-related
- •complications, if he/she were to participate in the study.
- •2. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
- •within 14 days for mild or asymptomatic infections or within 28 days for
- •severe/critical illness prior to randomization. Acute symptoms must have
- •resolved and there must be no sequelae that would place the subject at a higher
- •risk of clinically significant complications from receiving study treatment,
- •based on the Investigator*s assessment in consultation with the Sponsor Medical
- •3. Subject has any condition that confounds the ability to interpret data from
- •4. Subject has any of the following laboratory abnormalities:
- •a. Absolute neutrophil count (ANC) < 1,000 cells/µL. It is not permissible to
- •administer granulocyte colony-stimulating factor (GCSF) to achieve minimum ANC
- •b. Platelet count: < 75,000 cells/µL for subjects in whom < 50% of bone marrow
- •nucleated cells are plasma cells; or a platelet count < 50,000 cells/µL for
- •subjects in whom >= 50% of bone marrow nucleated cells are plasma cells. It is
- •not permissible to transfuse subjects to achieve minimum platelet counts.
- •c. Hemoglobin < 8 g/dL (< 4.9 mmol/L).
- •d. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2 or requiring
- •dialysis. The eGFR can be calculated using the modification of diet in renal
- •disease (MDRD) formula adjusted for actual BSA.
- •e. Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L).
- •f. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >
- •2.5 × upper limit of normal (ULN).
- •g. Serum total bilirubin > 1.5 × ULN or > 3.0 mg/dL for subjects with
- •documented Gilbert*s syndrome.
- •5. Subject has plasma cell leukemia, Waldenstrom*s macroglobulinemia or POEMS
- •syndrome ), or clinically significant amyloidosis.
- •6. Subject has peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain.
- •7. Subject has gastrointestinal disease that may significantly alter the
- •absorption of iberdomide and/or other oral study treatment.
- •8. Subject has 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 in situ (stage 0)
- •Carcinoma in situ of the cervix
- •Carcinoma in situ of the breast
- •Incidental histologic finding of prostate cancer (T1a or T1b using the TNM
- •[tumor, nodes, metastasis] clinical staging system) or prostate cancer that is
- •9. Subject with known central nervous system involvement with MM.
- •10. Subject has received immunosuppressive medication within the last 14 days
- •of initiating study treatment. 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
- •equivalent dose of an alternative glucocorticoid, see Table 7)
- •Steroids as premedication for hypersensitivity reactions (eg, computed
- 另有 1 项未显示
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