Relapsed multiple myeloma MedDRA version: 14.1 Level: PT Classification code 10028228 Term: Multiple myeloma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Code: NOX-A12
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Spiegelmer-A12
Current Sponsor code: NOX-A12
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type
Sponsors
NOXXON Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male or female, aged = 18 years 2.Diagnosis of relapsed multiple myeloma for which bortezomib/dexamethasone would be given as standard of care. 3.Bortezomib-naïve or bortezomib-sensitive patient (i.e. best response of PR or better, sus-tained for at least 6 months), who did not receive bortezomib during the last line of therapy for MM prior to this study. 4.Progressive disease according to International Myeloma Working Group criteria. 5.Pre-study WHO Performance Status = 2 and modified CIRS score of less than 7 6.Signed and dated, written informed consent. 7.Men and women of reproductive potential must agree to follow accepted contraception methods during treatment and for 3 months after completion of treatment. 8.Acceptable liver function: Bilirubin = 1.5 x upper limit of normal (ULN) (according to the Summary of Product Characteristics of Velcade). 9.Acceptable hematology and hemostasis status: Platelet count = 75 x 109/L, ANC > 0.75x109/L. 10.Acceptable renal function: Serum creatinine =1.5 ULN and/or calculated creatinine clearance = 50 mL/min (calculated according to Cockroft & Gault formula). 11.No clinically significant abnormalities of liver volume, liver hemodynamics or elasticity, measured by abdominal ultrasound. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 14 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14
Exclusion criteria
Exclusion criteria: 1.The patient has a history of, or is clinically suspicious for, cancer-related Central Nervous System disease. 2.Prior allogeneic stem cell transplant (alloSCT) or patients who are considered to be candidates for alloSCT as assessed by their treating physician. 3.Patient has a history of other active malignancies within 3 years prior to study entry, with the exception of: adequately treated in situ carcinoma of the cervix uteri; basal or squamous cell carcinoma of the skin; in situ carcinoma of the bladder; previous malignancy confined and surgically resected with curative intent. 4.The patient exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to: uncontrolled systemic infection (viral, bacterial, or fungal); diagnosis of fever and neutropenia within 1 week prior to study drug administration. 5.Female patient is pregnant or breast-feeding. 6.Known infection with HIV, active Hepatitis B or Hepatitis C. 7.The patient has a history of prior toxicity from bortezomib or dexamethasone that resulted in permanent discontinuation of respective treatments. 8.Clinical evidence of a current significant (grade 2 or higher) or progressive neuropathy. 9.Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to study drug administration. 10.Uncontrolled hypertension (defined as systolic blood pressure [BP] > 160 mm Hg or diastolic BP > 100 mm Hg). 11.Myocardial infarction or unstable angina within the past 6 months prior to study drug administration. Heart failure of New York Heart Association functional Class III or IV prior to study drug administration. 12.Evidence of bleeding diathesis (greater than normal risk of bleeding) or coagulopathy (in the absence of therapeutic anticoagulation). 13.Systemic illnesses or other severe concurrent disease or alcoholism, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and efficacy of the investigational treatments. 14.Known or suspected of not being able to comply with the trial protocol. 15.Having been previously enrolled in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of NOX-A12 alone (pilot group only) and in combination with VD To determine the overall response rate according to IMWG uniform response criteria (ORR = best response at least partial response(PR));Secondary Objective: • To determine the effect of NOX A12 alone and in combination with VD on the mobilization of peripheral blood CD34+ cells, plasma cells and myeloma cells • To determine additional response criteria adopted from the EBMT criteria such as minor response (MR), immunophenotypic CR and molecular CR after treatment with NOX-A12 combined with VD • To determine time to event endpoints such as progression free survival (PFS), time to progression (TTP) and duration of response (DOR) after treatment with NOX A12 combined with VD • To determine the plasma concentration of SDF-1 after treatment with NOX-A12 alone (pilot group only) and in combination with VD • To determine the pharmacokinetics of NOX A12 alone (pilot group only) and in combination with VD;Primary end point(s): Safety The safety evaluation will be based on the following assessments: • adverse events • vital signs • 12 lead ECGs • laboratory parameters (CBC, platelets, differential WBC count, serum chemistry, coagulation parameters, urinalysis) • immunogenicity Efficacy Assessment of the overall tumor response - as measured by serum free light chain, serum and urinary M-protein, clonal plasma cell counts in blood and bone marrow, plasmacytoma size measurements and prescence of bone lesions.;Timepoint(s) of evaluation of this end point: Safety - throughout the treatment period and for 30 days post last dose. Efficacy - at the end of cycle 4 and cycle 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • mobilisation of CD34+ cells, plasma cells and myeloma cells • immunophenotyping of CD34+ cells, plasma cells and myeloma cells • survival free of disease • pharmacokinetic analysis of SDF-1 in plasma • pharmacokinetic analysis of NOX-A12 in plasma ;Timepoint(s) of evaluation of this end point: Characteristation of blood circulating cells - Pilot group - Day1,2 and 4 post dose. All patients - Day 1 and 2 Cycle 1 and 4. SDF-1 and NOX-A12 pharmacokinetic analysis - pilot group Day1,2 and 4 post dose. With VD - Day1,4,8,11 and 21 of Cycle 1 and 4. | — |
Countries
Austria, Germany, Italy
Contacts
Public ContactClinical Operations
AMS Advanced Medical Services
Outcome results
None listed