A Phase II open-label, single-arm, multicenter trial of MP0250 plus bortezomib+dexamethasone in patients with refractory and relapsed multiple myeloma - A single arm study of MP0250+bortezomib+Dexamethasone in patients with Refractory and relapsed MM

Molecular Partners AG0 个研究点目标入组 54 人开始时间: 2016年11月29日最近更新: 2021年8月2日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Molecular Partners AG
入组人数: 54

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

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研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•Participants are eligible to be included in the study only if all of the
•following criteria apply:
•Type of Participant and Disease Characteristics
•1. Patients with MM who have received:
•Part 1 (Completed)
•- =2 lines of therapy (including bortezomib and an IMiD), and
•- Have shown no response (i.e. stable disease) to, or
•- Have progressed in the most recent treatment, or
•- Have progressed within 60 days of the most recent therapy.
•- =2 lines of prior therapy that included a proteasome inhibitor
•(bortezomib, carfilzomib or both) and an IMiD (thalidomide,
•lenalidomide and/or pomalidomide) either alone or in combination and,
•- a response no better than SD lasting at least 4 months on a
•bortezomib- or carfilzomib-based, regimen as last line of therapy or,
•- progression on treatment or within 60 days of stopping a bortezomibor
•carfilzomib-based regimen as last line of therapy.
•Note: For transplant-eligible patients enrolled to Part 1 or Part 2,
•induction plus conditioning chemotherapy/ASCT +/- maintenance
•therapy constitute one regimen.
•2. Presence of a measurable disease with at least one of the following
•- Serum M protein =0.5 g/dL, or
•- Urine M protein =200 mg/24 h, or
•- Involved serum free light chain (FLC) levels >100 mg/L and abnormal
•kappa/lambda (?/?) ratio in patients without detectable serum or urine
•M protein, or
•- For patients with immunoglobulin A (IgA) myeloma whose disease can
•only be reliably measured by quantitative immunoglobulin measurement, a serum IgA level =0.5g/dL.
•3. Eastern Cooperative Oncology Group (ECOG) performance status (0 to 1)
•4. Life expectancy >3 months
•5. Adequate hepatic function at Screening, with aspartate
•aminotransferase (AST) and alanine aminotransferase (ALT) <3x ULN
•and total bilirubin <2 x upper limit of normal (ULN). For patients with
•Gilbert's syndrome (Gilbert-Meulengracht syndrome), higher bilirubin of
•5 x ULN is acceptable
•6. Absolute neutrophil count (ANC) =1000/mm3 at Screening. Screening
•ANC must be independent of growth factor support for =1 week
•7. Hemoglobin =8.0 g/dL at Screening. Use of erythropoietic stimulating
•factors and red blood cell (RBC) transfusions per institutional guidelines
•is allowed, however most recent RBC transfusion must not have been
•done within 7 days prior to obtaining screening hemoglobin
•8. Platelet count =50 000/mm3 at Screening. Patients must not have
•received platelet transfusions for at least 1 week prior to obtaining the
•screening platelet count
•9. Measured or calculated creatinine clearance (CrCl) of = 45 mL/min at
•Screening based on the Cockcroft and Gault formula:
•(140 - Age) x Mass (kg) / (72 x Creatinine mg/dL); multiply result by
•0.85 if female
•10. Serum albumin concentration = 25 g/L Note: Patients with lower
•levels of serum albumin at baseline may receive albumin
•supplementation to comply with this criterion.
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排除标准

•Patients are excluded from the study if any of the following criteria
•Medical Conditions
•1. Patients with the following diseases:
•- Monoclonal gammopathy of undetermined significance (MGUS) of nonimmunoglobulin (Ig)M and IgM subtypes
•- Light chain MGUS
•- Solitary plasmacytoma (alone or with minimal marrow involvement)
•- Systemic Ig light chain amyloidosis
•- Waldenstrom's Macroglobulinemia
•- Myelodysplastic syndrome
•- Plasma cell leukemia defined as a plasma cell count >2000/mm3
•- Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein,
•and skin changes (POEMS) syndrome
•2. Peripheral neuropathy Grade 2 or higher at Screening or patients with
•a history of Grade 3/4 neuropathy or Grade 2 with pain
•3. Prior or concurrent malignancy, except for:
•- Adequately treated basal cell or squamous cell skin cancer, carcinoma
•in-situ of the cervix or breast or very low and low risk prostate cancer in
•active surveillance
•- Or any other cancer from which the patient has been disease-free for
•4. Active congestive heart failure (New York Heart Association [NYHA]
•Class III to IV), symptomatic cardiac ischemia, or conduction
•abnormalities uncontrolled by conventional intervention. Myocardial
•infarction within 6 months prior to screening
•5. Uncontrolled, hypertension (defined as systolic blood pressure (SBP)
•>150 mm Hg, diastolic blood pressure (DBP) >100 mm Hg despite
•antihypertensive medication)
•6. Stroke, or transient ischemic attack within 6 months of Screening,
•clinically significant bleeding and vascular disease
•7. Abdominal fistula, gastrointestinal perforation, or intra-abdominal
•abscess within the past 6 months
•8. Significant concurrent, uncontrolled medical condition including, but not limited to, severe wound healing complication, renal (except related
•to MM), hepatic, hematological except MM, gastrointestinal, endocrine,
•pulmonary, neurological, cerebral or psychiatric disease
•9. Acute active infection requiring systemic antibiotics, antiviral (except
•antiviral therapy directed at hepatitis B) or antifungal agents within 14
•days prior to screening
•10. Clinical signs of or documented leptomeningeal or cerebral
•involvement of MM
•Prior/Concomitant Therapy
•11. Treatment with ixazomib as last line of therapy in Part 2
•12. Therapy with approved or investigational anticancer therapeutics
•within 21 days (or in the case of nitrosureas, within 6 weeks) prior to
•treatment (except anti-myeloma treatment with a carfilzomib- or
•bortezomib-based regimen in Part 2) Note: Patients must have
•recovered from pre-existing, treatment-related adverse events to Grade
•13. Autologous stem cell transplantation (ASCT) within 12 weeks before
•the date of enrollment
•14. Prior allogeneic stem cell transplantation with active graft-versus-host-disease
•15. Major surgery within 21 days prior to Screening
•16. Immunotherapy within 21 days prior to Screening
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研究者

发起方

Molecular Partners AG

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