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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)

Phase 2
18 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

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)

Malignant plasma cells express high levels of CXCR4 chemokine receptors, which cause cell
migration and adhesion to stromal cells secreting the CXCR4 ligand, CXCL12 (SDF-1). NOX A12
is a specific CXCL12 antagonist and may improve chemotherapy by disrupting CXCR4-CXCL12
interactions, thereby mobilizing plasma cells from protective tissue microenvironments to
the blood. Furthermore, SDF-1 inhibition may alter the activation status of plasma cells,
thereby triggering apoptosis or sensitization of plasma cells towards chemotherapy.

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 >

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate (ORR = best response at least partial response (PR))

Outcome Description:

Assessment of the overall tumor response after cycle 4 and 8 will be the primary efficacy endpoint. The recommendations for the uniform reporting of clinical trials as published by the International Myeloma Workshop Consensus Panel 1 in 2011 will be applied.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Stefan Zeitler, MD

Investigator Role:

Study Director

Investigator Affiliation:

Noxxon Pharma AG


Italy: The Italian Medicines Agency

Study ID:




Start Date:

March 2012

Completion Date:

March 2015

Related Keywords:

  • Multiple Myeloma
  • Relapsed Multiple Myeloma
  • NOX-A12
  • Velcade
  • Dexamethasone
  • Spiegelmer
  • Chemosensitization
  • Stromal cell-derived factor-1 (SDF-1)
  • CXCL12
  • Multiple Myeloma
  • Neoplasms, Plasma Cell