NOX-A12 in Combination With Bortezomib and Dexamethasone in Relapsed Multiple Myeloma

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2015
• Main ID: NCT01521533
• Date of registration: 26/01/2012
• Prospective Registration: Yes
• Primary sponsor: NOXXON Pharma AG
• Public title: NOX-A12 in Combination With Bortezomib and Dexamethasone in Relapsed Multiple Myeloma
• Scientific title: A Multi-center, Open Label, Uncontrolled, Phase IIA Clinical Trial Evaluating the Safety and Efficacy of NOX A12 in Combination With a Background Therapy of Bortezomib and Dexamethasone (VD) in Previously Treated Patients With Multiple Myeloma (MM)
• Date of first enrolment: March 2012
• Target sample size: 28
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01521533
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Austria, France, Germany, Italy

Contacts

• Name: Kai Riecke, MD
• Affiliation: NOXXON Pharma AG

Key inclusion & exclusion 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,
sustained 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).

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.

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Myeloma

Intervention(s)

Drug: NOX-A12

Primary Outcome(s)

Safety and tolerability of NOX A12 alone and in combination with VD [Time Frame: 18 months]

Overall response rate (ORR = best response at least partial response (PR)) [Time Frame: 6 months]

Secondary Outcome(s)

Time to event endpoints such as Progression Free Survival (PFS), Time To Progression (TTP) and Duration Of Response (DOR) following treatment with NOX A12 in combination with VD [Time Frame: 18 months]

Plasma concentration of SDF-1 after treatment with NOX-A12 alone (pilot group only) and in combination with VD [Time Frame: 6 months]

Additional response criteria such as Minor Response (MR), immunophenotypic Complete Response and molecular Complete Response [Time Frame: 6 months]

Effect of NOX A12 alone and combined with VD on the mobilization of peripheral blood CD34+ cells, plasma cells and myeloma cells [Time Frame: 6 months]

Pharmacokinetics of NOX A12 alone (pilot group only) and combined with VD [Time Frame: 6 months]

Secondary ID(s)

2011-004651-40

SNOXA12C301

Source(s) of Monetary Support

Please refer to primary and secondary sponsors