NL-OMON48607已完成2 期
A Phase 2, Randomized, Open-Label Study Comparing Oral Ixazomib/Dexamethasone and Oral Pomalidomide/Dexamethasone in Relapsed and/or Refractory Multiple Myeloma - C16029
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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 64（—）
入选标准
- •Adult patients (aged >=18 years) who have been diagnosed with multiple myeloma
- •(MM) according to standard criteria.
- •All patients must have had a relapse or PD after having received 2 or more
- •prior lines of systemic therapy. (A line of therapy is defined as 1 or more
- •cycles of a planned treatment program; this may consist of 1 or more planned
- •cycles of single-agent therapy or combination therapy, as well as a sequence of
- •treatments administered in a planned manner. For example, a planned treatment
- •approach of induction therapy followed by autologous stem-cell transplantation,
- •followed by maintenance is considered 1 line of therapy. Typically each line of
- •therapy is separated by PD.)
- •All patients must be refractory to lenalidomide, defined as having received
- •at least 2 consecutive cycles of lenalidomide as a single agent or within a
- •lenalidomide-containing regimen and having had PD during treatment with or
- •within 60 days after the last dose of lenalidomide. The starting dose of
- •lenalidomide should have been 25 mg (or as low as 10 mg in the case of renal
- •function impairment or other safety concern), and the final dose should have
- •been a minimum of 10 mg.
- •All patients must have received at least 2 consecutive cycles of a
- •bortezomib- or carfilzomib-containing regimen, and either:
- •- Achieved at least a partial response (PR) and did not have PD during
- •treatment with or within 60 days after the last dose of bortezomib or
- •carfilzomib,
- •- Had bortezomib and/or carfilzomib intolerance (defined as discontinuation
- •because of drug-related adverse events (AEs) before completion of the planned
- •treatment course) without PD upon the start of the next regimen.
- •All patients must have an Eastern Cooperative Oncology Group score of 0 to 2.
- •All patients must have measurable disease defined by serum M-protein >= 1 g/dL
- •(>=10 g/L) or urine M-protein >=200 mg/24 hours and must have documented MM
- •isotype by immunofixation (central laboratory).
排除标准
- •Patients meeting any of the following exclusion criteria are not to be enrolled
- •in the study:
- •- Patients must not have received prior ixazomib or pomalidomide and must not
- •have been a participant in a previous ixazomib clinical study.
- •- Prior allogenic bone marrow transplantation in any prior line of therapy or
- •prior autologous SCT in the last prior line of therapy*unless the autologous
- •performed a year or more before disease progression.
- •- Female patients who are lactating and breastfeeding or have a positive serum
- •pregnancy test during the Screening period.
- •- Any serious medical or psychiatric illness that could, in the investigator's
- •opinion, potentially interfere with the completion of treatment according to
- •this protocol,
- •such as life-threatening illness unrelated to cancer.
- •- Diagnosed with or treated for another malignancy within 2 years before
- •randomization, or previously diagnosed with another malignancy and
- •have any evidence of residual, persistent, or recurrent disease. Patients with
- •nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if
- •undergone complete resection.
- •- Diagnosis of smoldering MM (see Appendix D), Waldenström's macroglobulinemia,
- •POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and
- •skin changes) syndrome, plasma cell leukemia, primary amyloidosis,
- •myelodysplastic syndrome, or myeloproliferative syndrome.
- •- Known allergy to any of the study medications or their analogues, or
- •excipients in the various formulations.
- •- Peripheral neuropathy Grade 1 with pain or Grade 2 or higher peripheral
- •neuropathy of any cause on clinical examination during the Screening period.
- •- Treatment with any investigational products or with chimeric or fully human
- •monoclonal antibodies within 30 days before randomization, systemic anticancer
- •therapy or radiotherapy within 14 days before randomization (Note: spot
- •radiation for areas of pain is permitted), and major surgery within 14 days
- •randomization.
- •- Known gastrointestinal disease or gastrointestinal procedure that could
- •interfere with the oral absorption or tolerance of study therapy, including
- •difficulty swallowing.
- •- Serious infection requiring parenteral antibiotic therapy or any other
- •serious infection within 14 days before randomization.
- •- Central nervous system involvement with MM (by clinical symptoms and signs).
- •- Ongoing or active systemic infection, known human immunodeficiency virus-RNA
- •positive, known hepatitis B surface antigen seropositive, or known hepatitis C
- •virus-RNA positive.
- •Note: Patients who have positive hepatitis B core antibody can be enrolled but
- •must have hepatitis B virus-DNA negative. Patients who have positive hepatitis C
- •antibody can be enrolled but must have hepatitis C virus-RNA negative.
- •- Systemic treatment with strong cytochrome P-450 3A inducers (rifampin,
- •rifapentine,rifabutin, carbamazepine, phenytoin, phenobarbital) or use of St.
- •wort within 14 days before randomization.
- •- Admission or evidence of illicit drug use, drug abuse, or alcohol abuse.
- •- History of severe cutaneous reactions, including hypersensitivity reactions
- •such as Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and
- •Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), in the context <br
研究者
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