A clinical trial of NOX-A12 in patients with multiple myeloma who have previously been treated and who will be receiving bortezomib and dexamethasone treatment

• Conditions: Relapsed multiple myeloma; MedDRA version: 14.1Level: PTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2011-004651-40-IT
• Lead Sponsor: OXXON PHARMA AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-08
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 28

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
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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),
AST (SGOT) and ALT (SGPT) = 2.5 ULN at screening.
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: 0
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

1.The patient has a history of, or is clinically suspicious for, cancerrelated 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.
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified