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Multiple MyelomaPhase 3NCT00416273

A Study of Bortezomib as Consolidation Therapy in Patients With Multiple Myeloma

A Phase 3 study testing Bortezomib in people with Multiple Myeloma, run by Janssen-Cilag G.m.b.H at 38 sites in Germany.

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 determination of the event-free survival with and without Bortezomib consolidation therapy from the day of the first chemotherapeutic, myeloma-specific therapy measure, up to the occurrence of progression/recurrence or up to the occurrence of death. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Multiple Myeloma
What is being tested?
Bortezomib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
217 participants
Where
38 sitesGermany
Study dates
Dec 2006to May 2013
Phase
Phase 3
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 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients with multiple myeloma with prior therapy consisting of remission induction therapy and high dose chemotherapy followed by stem cell transplantation
  • Women must be postmenopausal or using safe contraception methods
  • Creatinin clearance has to be higher than 30 ml/min and whole blood count has to be within acceptable ranges

Who cannot join

  • No asecretory multiple myeloma
  • History of allergic reactions to bortezomib or mannitol
  • Expected life expectancy of less than 3 months
  • No other malignant disease beside basalioma either existing or history of
  • No history of severe cardio-pulmonary disease
  • Seizures

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

Germany38 sites

  • Study site

    Augsburg

  • Study site

    Bamberg

  • Study site

    Berg

  • Study site

    Berlin

  • Study site

    Bremen

  • Study site

    Cologne

  • Study site

    Dresden

  • Study site

    Duisburg

  • Study site

    Erlangen

  • Study site

    Eschweiler

  • Study site

    Frankfurt am Main

  • Study site

    Freiburg im Breisgau

  • Study site

    Goch

  • Study site

    Göttingen

  • Study site

    Greifswald

  • Study site

    Halle

  • Study site

    Hamburg

  • Study site

    Hamm

  • Study site

    Hanover

  • Study site

    Homburg

  • Study site

    Jena

  • Study site

    Karlsruhe

  • Study site

    Kempten

  • Study site

    Kiel

  • Study site

    Magdeburg

  • Study site

    Mainz

  • Study site

    München

  • Study site

    Münster

  • Study site

    Mutlangen

  • Study site

    Nuremberg

  • Study site

    Oldenburg

  • Study site

    Regensburg

  • Study site

    Rostock

  • Study site

    Stuttgart

  • Study site

    Ulm

  • Study site

    Villingen-Schwenningen

  • Study site

    Wiesbaden

  • Study site

    Würzburg

Other trials in Germany

About this study

Official title: Consolidation Therapy With Bortezomib <= 60 Year Old Patients With Multiple Myeloma

The purpose of this study is determination of the event-free survival with and without Bortezomib consolidation therapy from the day of the first chemotherapeutic, myeloma-specific therapy measure, up to the occurrence of progression/recurrence or up to the occurrence of death.

Read the detailed description

This is a two-arm (group), open-label (all people know the identity of the intervention), prospective (a study in which the patients are identified and then followed forward in time for the outcome of the study) randomized (the study medication is assigned by chance), multi-center study. Approximately 385 patients will be enrolled in this study. Patients will be randomly assigned to treatment or observation group in a ratio of 1:1. The study duration from screening up to the study end is up to 27 weeks. Then the patients will be observed until the last included patient has completed a 30 month post observational phase. The patients in the treatment arm will receive 4 cycles of a therapy. Each cycle lasts for a 35 days. Safety evaluations will include assessment of adverse events, vital signs, physical examination, electrocardiograms, and clinical laboratory tests.

Being tested
Bortezomib, No intervention
Keywords
Multiple Myeloma, Bortezomib, PS341, Proteasome inhibitor, Consolidation therapy
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 administered as 1.6 mg/m2 per body surface area on the days 1, 8, 15, 22 for the duration of 4 therapy cycles.

  • No interventionDrug

    Participants in the observation group will be observed and will not receive any consolidation therapy.

Study groups in NCT00416273
Study groupRoleWhat they receive
Treatment groupExperimentalParticipants in the treatment group will receive Bortezomib at a dosage of 1.6 mg/m2.
Receives: Drug: Bortezomib
Observation groupExperimentalParticipants in the observation group will not receive any consolidation therapy.
Receives: Drug: No intervention

What is being measured

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

  1. Number of patients with event-free survival (PFS)

    Measured: From date of first chemotherapeutic myeloma-specific treatment measure until date of disease progression or death, whichever occurred first, as assessed approximately 30-60 months after the last patient was enrolled

Secondary outcomes (10)

  1. Number of patients with event free survival (EFS)

    Measured: From date of first chemotherapeutic myeloma-specific treatment measure until the occurrence of the beginning of a new chemotherapeutic therapy,or death, whichever occurred first, as assessed approximately 30-60 months after the last patient was enrolled

  2. Response rates

    Response will be determined according to EBMT (European Group for Blood and Marrow Transplantation) criteria; VGPR (very good partial response) will be added as an additional response criteria. VGPR is measured as at least 90 percents reduction of the monoclonal protein in the serum over at least 6 weeks.

    Measured: Up to Week 25

  3. Overall survival

    Time interval in months between the date of randomization and the participant's death from any cause.

    Measured: From date of first chemotherapeutic myeloma-specific treatment measure until date of disease progression or death, whichever occurred first, as assessed approximately 30-60 months after the last participant was enrolled

  4. Time to progression

    Time to progression is time interval in months until progression of disease, censoring for death or drop-out without progression.

    Measured: From date of first chemotherapeutic myeloma-specific treatment measure until date of disease progression or death, whichever occurred first, as assessed approximately 30-60 months after the last participant was enrolled

  5. Duration of response

    Duration of the response, measured from the day on which a response (at least minimal response) was documented for the first time after the start of the therapy, up until the day of the documentation of a progression/recurrence requiring therapy.

    Measured: Up to Week 25

  6. Number of patients with toxicities over the treatment period

    Toxicities will be assessed according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 3.

    Measured: Up to Week 24

  7. Change From Baseline in European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30)

    EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients. It is composed of 30 items, multi-item measure (28 items) and 2 single-item measures. For the multiple item measure, 4-point scale is used and the score for each item range from "1 = not at all" to "4 = very much". Higher scores indicate worsening. The 2 single-item measure involves question about the overall health and overall quality of life which will be rated on a 7-point scale ranging from "1 = very poor" to "7 = excellent". Lower scores indicate worsening.

    Measured: Baseline (Day 1), Enpoint (30-60 months)

  8. Number of the patients with skeletal related event (SRE)

    Pathological fracture, spinal cord compression, radiotherapy of a bone lesion, surgical therapy of a bone lesion will be considered as skeletal related events.

    Measured: Up to 30-60 months

  9. Time interval from the day of the transplantation up to the occurrence of the first SRE

    Measured: Up to 30-60 months

  10. Change From Baseline in EuroQol-5 (EQ-5D) Health Status Index to end point (30-60 months)

    Change from Baseline to end point (30-60 months) in Euro Quality of life (Qol)-5 Dimension Questionnaire (EQ-5D). A higher score indicates an improvement in health in the Health Status Index. The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing dead.

    Measured: Baseline (Day 1) and end point (30-60 months)

Timeline

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

  1. First posted27 Dec 2006 (estimated)
  2. Study startDec 2006
  3. Primary completionMay 2013
  4. Study completionMay 2013

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
217 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00416273
Sponsor's protocol ID
CR006124
Other IDs
26866138MMY3012, 2005-004948-31, 2005
Status last verified
Mar 2015
First submitted
22 Dec 2006
Last updated
6 Mar 2015
Results posted
No
Data monitoring committee
No

Publications

  • Straka C, Knop S, Vogel M, Muller J, Kropff M, Metzner B, Langer C, Sayer H, Jung W, Durk HA, Salwender H, Wandt H, Bassermann F, Gramatzki M, Rosler W, Wolf HH, Brugger W, Fischer T, Liebisch P, Engelhardt M, Einsele H. Bortezomib consolidation following autologous transplant in younger and older patients with newly diagnosed multiple myeloma in two phase III trials. Eur J Haematol. 2019 Sep;103(3):255-267. doi: 10.1111/ejh.13281. Epub 2019 Jul 19.

    PubMed 31231828

  • Einsele H, Knop S, Vogel M, Muller J, Kropff M, Metzner B, Langer C, Sayer H, Jung W, Durk HA, Salwender H, Wandt H, Bassermann F, Gramatzki M, Rosler W, Wolf HH, Brugger W, Engelhardt M, Fischer T, Liebisch P, Straka C. Response-adapted consolidation with bortezomib after ASCT improves progression-free survival in newly diagnosed multiple myeloma. Leukemia. 2017 Jun;31(6):1463-1466. doi: 10.1038/leu.2017.83. Epub 2017 Mar 15. No abstract available.

    PubMed 28293022

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bortezomib in people with Multiple Myeloma, run by Janssen-Cilag G.m.b.H at 38 sites in Germany.

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 3 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 6 Mar 2015. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Number of patients with event-free survival (PFS) (time frame: From date of first chemotherapeutic myeloma-specific treatment measure until date of disease progression or death, whichever occurred first, as assessed approximately 30-60 months after the last patient was enrolled). 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 NCT00416273, which also lists 2 linked publications.

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 Mar 2015.

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