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Multiple MyelomaPhase 2NCT01521533

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

A Phase 2 study testing NOX-A12 in people with Multiple Myeloma, run by TME Pharma AG at 10 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and efficacy of NOX A12 alone and in combination with a background therapy of bortezomib and dexamethasone (VD) chemotherapy in previously treated patients with multiple myeloma (MM). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
NOX-A12
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
10 sitesin 4 countries
Study dates
Mar 2012to Sep 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, aged ≥ 18 years.
  • Diagnosis of relapsed multiple myeloma for which bortezomib/dexamethasone would be given as standard of care.
  • 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.
  • Progressive disease according to International Myeloma Working Group criteria.
  • Pre-study WHO Performance Status ≤ 2 and modified CIRS score of less than 7.
  • Signed and dated, written informed consent.
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  • Men and women of reproductive potential must agree to follow accepted contraception methods during treatment and for 3 months after completion of treatment.
  • Acceptable liver function: Bilirubin ≤ 1.5 x upper limit of normal (ULN).
  • Acceptable hematology and hemostasis status: Platelet count ≥ 75 x 109/L, ANC > 0.75x109/L.
  • Acceptable renal function: Serum creatinine ≤1.5 ULN and/or calculated creatinine clearance ≥ 50 mL/min (calculated according to Cockroft \& Gault formula).
  • No clinically significant abnormalities of liver volume, liver hemodynamics or elasticity, measured by abdominal ultrasound.

Who cannot join

  • The patient has a history of, or is clinically suspicious for, cancer-related Central Nervous System disease.
  • Prior allogeneic stem cell transplant (alloSCT) or patients who are considered to be candidates for alloSCT as assessed by their treating physician.
  • 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.
  • 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.
  • Female patient is pregnant or breast-feeding.
  • Known infection with HIV, active Hepatitis B or Hepatitis C.
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  • The patient has a history of prior toxicity from bortezomib or dexamethasone that resulted in permanent discontinuation of respective treatments.
  • Clinical evidence of a current significant (grade 2 or higher) or progressive neuropathy.
  • Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to study drug administration.
  • Uncontrolled hypertension (defined as systolic blood pressure [BP] > 160 mm Hg or diastolic BP > 100 mm Hg).
  • 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.
  • Evidence of bleeding diathesis (greater than normal risk of bleeding) or coagulopathy (in the absence of therapeutic anticoagulation).
  • 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.
  • Known or suspected of not being able to comply with the trial protocol.
  • Having been previously enrolled in this clinical trial.

Trial locations and contacts

10 sites in 4 countries.

10 sites in 4 countries

Germany3 sites

  • University Hospital Freiburg, Medizinische Universitätsklinik, Innere Medizin I, Haematologie und Onkologie

    Freiburg im Breisgau

  • University Hospital Münster, Medizinische Klinik und Poliklinik A

    Münster

  • University Hospital Ulm, Zentrum für Innere Medizin,

    Ulm

Other trials in Germany

Italy3 sites

  • University Hospital San Martino, Department of Hematology and Oncology

    Genova

  • Niguarda Ca'Granda Hospital, Department of Hematology

    Milan

  • Sapienza University of Rome, Department of Hematology

    Rome

Other trials in Italy

Austria2 sites

  • University Hospital Salzburg, Department of Medicine III, Center of Oncology and Hematology

    Salzburg

  • Wilhelminenspital, Department of Medicine I, Center of Oncology and Hematology

    Vienna

Other trials in Austria

France2 sites

  • Hôpital Huriez, Centre Hospitalier Régional Universitaire de Lille

    Lille

  • Hôpital Saint Antoine - Service des maladies du sang et de thérapie cellulaire

    Paris

Other trials in France

About this study

Official 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)

The purpose of this study is to evaluate the safety and efficacy of NOX A12 alone and in combination with a background therapy of bortezomib and dexamethasone (VD) chemotherapy in previously treated patients with multiple myeloma (MM).

Read the detailed description

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.

Being tested
NOX-A12
Keywords
Relapsed Multiple Myeloma, NOX-A12, Velcade, Dexamethasone, Spiegelmer, Chemosensitization, Stromal cell-derived factor-1 (SDF-1), CXCL12
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NOX-A12Drug

    Also called olaptesed

    Pilot Group (NOX A12 single agent, and combined with VD):

    • 3 cohorts of 3 patients will receive treatment with NOX A12 alone at a single dose of 1, 2 or 4 mg/kg i.v. 2 weeks before the combination treatment of NOX A12 and VD will start. The combination of NOX A12 and VD will follow a dose titration design beginning at 1 mg/kg NOX A12 (cycle 1) proceeding to dose levels of 2 mg/kg (cycle 2) and 4 mg/kg (cycle 3) NOX A12 in combination with VD. This is followed by consolidation in cycles 4-8 when NOX-A12 will be kept at the highest individually titrated dose.

    Expansion Group (NOX A12 in combination with VD):

    • Expansion patients will not receive single agent NOX-A12, but will receive combination treatment as for the pilot group.
Study groups in NCT01521533
Study groupRoleWhat they receive
NOX-A12ExperimentalNot described
Receives: Drug: NOX-A12

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: 6 months

  2. Safety and tolerability of NOX A12 alone and in combination with VD

    The safety evaluation will be based on the following assessments:

    • Adverse events
    • Vital signs
    • 12 lead ECGs
    • Laboratory parameters
    • Abdominal ultrasound
    • Immunogenicity

    Measured: 18 months

Secondary outcomes (5)

  1. Effect of NOX A12 alone and combined with VD on the mobilization of peripheral blood CD34+ cells, plasma cells and myeloma cells

    Measured: 6 months

  2. Additional response criteria such as Minor Response (MR), immunophenotypic Complete Response and molecular Complete Response

    Measured: 6 months

  3. 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

    Measured: 18 months

  4. Plasma concentration of SDF-1 after treatment with NOX-A12 alone (pilot group only) and in combination with VD

    Measured: 6 months

  5. Pharmacokinetics of NOX A12 alone (pilot group only) and combined with VD

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionSep 2014
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01521533
Sponsor's protocol ID
SNOXA12C301
Other IDs
2011-004651-40
Status last verified
Oct 2015
First submitted
26 Jan 2012
Last updated
6 Oct 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.

    PubMed 30957581

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NOX-A12 in people with Multiple Myeloma, run by TME Pharma AG at 10 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany, Italy, Austria, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR = best response at least partial response (PR)) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01521533, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2015.

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