AzTrials
AzTrials

Multiple MyelomaPhase 2NCT00431769

An Efficacy and Safety Study of Bortezomib Re-treatment in Multiple Myeloma

A Phase 2 study testing Bortezomib in people with Multiple Myeloma, run by Janssen-Cilag International NV at 38 sites in 8 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the safety and efficacy of bortezomib in participants with multiple myeloma who have previously responded to a bortezomib based therapy. 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?
Bortezomib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
38 sitesin 8 countries
Study dates
Jun 2006to Jan 2010
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

  • Participant was previously diagnosed with multiple myeloma based on standard criteria and had measurable disease. Measurable disease for secretory multiple myeloma was defined as any quantifiable serum M-protein value (generally, but not exclusively, greater than (>) 1 gram per deciliter (g/dL) immunoglobulin (Ig) G Myeloma protein (M-protein) and >0.5 g/dL Ig A) or urine light-chain excretion of equal to (=) or >200 milligram (mg)/24 hour
  • Participant previously tolerated 1.0 or 1.3 mg/metersquare (m^2) bortezomib alone or in combination with other agents and had complete response (CR) or partial response (PR) upon completion of bortezomib therapy
  • It had been greater than or equal to (>=) 6 months since the participant's last bortezomibdose and the participant had progressive disease (PD) if prior response to bortezomib was PR or the participant had relapsed from CR
  • Participant had a life expectancy >3 months
  • If female, the participant was either postmenopausal or surgically sterilized or willing to use an acceptable method of birth control from screening through at least 30 days after completion of the last cycle

Who cannot join

  • Participant had received chemotherapy, radiotherapy, antibody, immunotherapy, or experimental therapy to treat multiple myeloma since their last dose of bortezomib. Note: participants could have received localized palliative radiotherapy for complications due to osteolytic bone lesions. Participants could have received steroids (dexamethasone or equivalent) or thalidomide or interferon as maintenance therapy since their last dose of bortezomib according to local standard of care. In addition, participants could have received a cumulative dose of up to 160 mg dexamethasone or equivalent as emergency therapy within 4 weeks prior to enrolment. Participants could have received high dose therapy/stem cell transplantation after induction regimen containing bortezomib, but only if PR or CR was observed during bortezomib containing induction therapy
  • Participant had uncontrolled or severe cardiovascular disease, including myocardial infarction within 6 months of enrolment or had New York Heart Association Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, severe uncontrolled ventricular arrhythmias or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
  • Participant had poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to the protocol
  • Participant had another malignancy within the past 5 years. Exceptions were made for the following if they were treated and not active: basal cell or non-metastatic squamous cell carcinoma of the skin, cervical carcinoma in situ or International Federation of Gynecology and Obstetrics Stage 1 carcinoma of the cervix
  • Patient has an uncontrolled or severe cardiovascular disease, within 6 months of enrolment
  • Female participant was pregnant or breast feeding. Confirmation that the participant was not pregnant was to be established by a negative beta human chorionic gonadotropin pregnancy test result obtained during the Screening period. Pregnancy testing was not required for post menopausal or surgically sterilized women.

Trial locations and contacts

38 sites in 8 countries.

38 sites in 8 countries

Germany10 sites

  • Study site

    Bad Soden

  • Study site

    Berlin

  • Study site

    Cologne

  • Study site

    Erlangen

  • Study site

    Hamburg

  • Study site

    Hamm

  • Study site

    Hanover

  • Study site

    Kiel

  • Study site

    Mainz

  • Study site

    Würselen

Other trials in Germany

Spain8 sites

  • Study site

    Barcelona

  • Study site

    Cadiz

  • Study site

    Málaga

  • Study site

    Salamanca

  • Study site

    Santiago de Compostela

  • Study site

    Seville

  • Study site

    Toledo

  • Study site

    Zaragoza

Other trials in Spain

France6 sites

  • Study site

    Dijon

  • Study site

    Limousis

  • Study site

    Marseille

  • Study site

    Nantes

  • Study site

    Paris

  • Study site

    Pessac

Other trials in France

Belgium4 sites

  • Study site

    Antwerp

  • Study site

    Brussels

  • Study site

    Ghent

  • Study site

    Roeselare

Other trials in Belgium

Austria3 sites

  • Study site

    Graz

  • Study site

    Oberpullendorf

  • Study site

    Vienna

Other trials in Austria

Greece3 sites

  • Study site

    Athens

  • Study site

    Pátrai

  • Study site

    Thessalonikis

Other trials in Greece

Portugal3 sites

  • Study site

    Almada

  • Study site

    Coimbra

  • Study site

    Lisbon

Other trials in Portugal

Luxembourg1 site

  • Study site

    Luxembourg

Other trials in Luxembourg

About this study

Official title: A Phase II, Open-Label Trial Using Velcade for ReTreatment of Multiple Myeloma Subjects Following an Initial Response to Velcade

The purpose of this study is to evaluate the safety and efficacy of bortezomib in participants with multiple myeloma who have previously responded to a bortezomib based therapy.

Read the detailed description

This is an Open-Label (all people know the identity of the intervention), non-randomized, multicenter (when more than one hospital or medical school team work on a medical research study), single arm study to evaluate the safety and efficacy of bortezomib in participants with multiple myeloma (cancer of the types of cells normally found in bone marrow) who have previously responded to a bortezomib based therapy. Participants will be non-randomly assigned to single group bortezomib. Participants will be treated with bortezomib alone or in combination with another drug (dexamethasone). Bortezomib will be given intravenously (i.v. [into a vein]) twice Weekly, on Days 1, 4, 8 and 11 of each cycle followed by a 10-day (Days 12 to 21) rest period. The total duration of treatment period will be 8 cycles, each lasting 3 weeks. The initial bortezomib dose is the last tolerated dose (1.0 or 1.3 milligram per metersquare [mg/ m^2] on the previous bortezomib-based treatment. Participants who start the study on a dose of 1.0 mg/m^2 bortezomib and tolerate the dose well could have their dose escalated to 1.3 mg/m^2. Doses above 1.3 mg/m^2 are not allowed. A complete cycle comprises 4 doses of bortezomib. Dexamethasone will be first introduced in Cycles 1 to 5 (i.e.dexamethasone will not be introduced for the first time in Cycles 6 to 8). The median total dose of dexamethasone received per cycle ranges from 120 mg (cycle 7) to 160 mg (cycles 1 to 6 and 8). Efficacy will be primarily assessed by determining Best Confirmed Response according to the European Group for Blood and Marrow Transplantation (EBMT) criteria. Participant's safety will be monitored throughout the study.

Being tested
Bortezomib
Keywords
Multiple myeloma, Bortezomib, Dexamethasone, VELCADE
Medical subject headings
Multiple Myeloma

What participants receive

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

  • BortezomibDrug

    Bortezomib will be given intravenously (into a vein) twice weekly, on Days 1, 4, 8 and 11 and then a 10-day (Days 12 to 21) rest period, of each 3-week cycle for up to a total of 8 cycles. The initial bortezomib dose is 1.0 or 1.3 milligram per meter square (mg/m^2) depending on the previous bortezomib-based treatment, up to a maximum dose of 1.3 mg/m^2. Participants will receive bortezomib in combination with or without dexamethasone, in accordance with the standard of care. The median total dose of dexamethasone per cycle ranges from 120 mg (Cycle 7) to 160 mg (Cycles 1 to 6 and 8).

Study groups in NCT00431769
Study groupRoleWhat they receive
BortezomibExperimentalNot described
Receives: Drug: Bortezomib

What is being measured

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

  1. Best Confirmed Response to Bortezomib Re-Treatment

    Number of participants with best confirmed response to bortezomib Re-Treatment will be assessed by the European Group for Blood and Marrow Transplantation (EBMT) criteria. Best confirmed response is, if administration of bortezomib provide continuing or additional clinical benefit after previous bortezomib administration. The ordering of possible responses are Complete Response (CR), Partial Response (PR), Minimal Response (MR), No Change (NC) and Progressive Disease (PD)/relapse from CR. CR is the best response and the poorest response is PD or relapse from CR.

    Measured: Day 1 of every alternate cycle starting from Cycle 1 up to End of Treatment (30 to 42 days after last dose administration of bortezomib)

Secondary outcomes (4)

  1. Participants With Percent Change in Baseline Serum Monoclonal Protein (M-protein) Best Confirmed Response Category

    Number of participants with percent change in baseline serum M-protein best confirmed response category will be assessed by EBMT criteria. Best confirmed response is, if administration of bortezomib provide continuing or additional clinical benefit after previous bortezomib administration. Decrease in serum M-protein levels from baseline represents improvement. Participants having baseline M-protein value of <5 gram per liter (g/L) (serum) or <200 mg/24 hour (urine) will be classed in 'Not Evaluable' category and any response rate (RR) which is unconfirmed will be classed as 'Missing'.

    Measured: Day 1 of every alternate cycle starting from Cycle 1 up to End of Treatment (30 to 42 days after last dose administration of bortezomib)

  2. Participants with Percent Change in Baseline Urine Monoclonal Protein (M-protein) Best Confirmed Response Category

    Number of participants with percent change in baseline Urine M-protein best confirmed response category will be assessed by EBMT criteria. According to EBMT best confirmed response is, if administration of bortezomib provide continuing or additional clinical benefit after previous bortezomib administration. Decrease in urine M-protein levels from baseline represents improvement. Participants having baseline M-protein value of <5 g/L (serum) or <200 mg/24 hour(urine) will be classed in 'Not Evaluable' category and any RR which is unconfirmed will be classed as 'Missing'.

    Measured: Day 1 of every alternate cycle starting from Cycle 1 up to End of Treatment (30 to 42 days after last dose administration of bortezomib)

  3. Duration of Best Confirmed Response (DOR)

    The DOR is defined as the duration (months) from the date of the first evidence of a best confirmed response to the date of first documented evidence of PD (or relapse for participants who experienced CR). The PD or relapse are defined as one or more of following criteria: >25% increase in either serum or urine M-protein, >25% increase in plasma cells on bone marrow, Definite increase in size of bone lesion or plasmacytoma, Development of new bone lesion or plasmacytoma, Development of hypercalcaemia. The DOR will be calculated separately in participants with a best confirmed response of >=PR.

    Measured: Day 1 Cycle 1 up to last follow-up visit (8 weeks until PD)

  4. Time to Progression (TTP) for Best Confirmed Response

    The TTP is defined as the duration (in months) from the date of first study treatment administration (enrollment at Day 1, Cycle 1) until the date of first documented evidence of PD (or relapse for participants who experienced CR). PD or relapse are defined as one or more of the following criteria: ->25% increase in either serum or urine M-protein. ->25% increase in plasma cells on bone marrow. -Definite increase in size of bone lesion or plasmacytoma. -Development of new bone lesion or plasmacytoma. -Development of hypercalcaemia

    Measured: (Day 1 Cycle 1 up to last follow-up visit date (8 weeks until PD)

Timeline

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

  1. First posted6 Feb 2007 (estimated)
  2. Study startJun 2006
  3. Primary completionFeb 2009
  4. Study completionJan 2010

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
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00431769
Sponsor's protocol ID
CR010519
Other IDs
26866138MMY2036, 2005-005819-26, 2005
Status last verified
May 2014
First submitted
2 Feb 2007
Last updated
12 May 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bortezomib in people with Multiple Myeloma, run by Janssen-Cilag International NV at 38 sites in 8 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 5 inclusion and 6 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 12 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in Germany, Spain, France, Belgium, Austria and 3 more countries. 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?

Best Confirmed Response to Bortezomib Re-Treatment (time frame: Day 1 of every alternate cycle starting from Cycle 1 up to End of Treatment (30 to 42 days after last dose administration of bortezomib)). 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 NCT00431769.

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 12 May 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in