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Multiple MyelomaPhase 3NCT00416208

Consolidation Therapy With Bortezomib in Elderly Patients With Multiple Myeloma

A Phase 3 study testing Bortezomib in people with Multiple Myeloma, run by Janssen-Cilag G.m.b.H at 37 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 to evaluate the efficacy and safety of a consolidation therapy with bortezomib in patients with multiple myeloma aged 61 to 75. Read more about this study

Who is it for?
Ages 61 to 75 years
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
154 participants
Where
37 sitesGermany
Study dates
Oct 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 61 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who have had pretreatment with single or tandem high dose melphalan therapy and autologous stem cell transplantation as first line therapy
  • at least stable disease after stem cell transplantation
  • adequate hematological, hepatic and renal lab parameters
  • karnofsky status of 70 or more

Who cannot join

  • non-secretory multiple myeloma
  • previous treatment with bortezomib
  • allogenic stem cell transplantation
  • other co-existing malignancy beside basaliome
  • peripheral neuropathy
  • epilepsia
Show all 9Show fewer
  • other severe comorbidities (renal, hepatic, cardiovascular, metabolic, infectious etc.)
  • history of allergic reactions to bortezomib or mannitol
  • expected life expectancy of less than 3 months

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

Germany37 sites

  • Study site

    Bamberg

  • Study site

    Berg

  • Study site

    Berlin

  • Study site

    Bremen

  • Study site

    Dortmund

  • 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

    Jena

  • Study site

    Karlsruhe

  • Study site

    Kempten

  • Study site

    Kiel

  • Study site

    Kÿln N/A

  • Study site

    Lübeck

  • Study site

    Magdeburg

  • 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

    Trier

  • 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 in Patients With Multiple Myeloma Aged 61 to 75

The purpose of this study is to evaluate the efficacy and safety of a consolidation therapy with bortezomib in patients with multiple myeloma aged 61 to 75.

Read the detailed description

No data supporting the use of bortezomib as a consolidation therapy in multiple myeloma patients are available. Ínterferon tested as consolidation / maintenance therapy has not uniformly proven to prolong survival. In this study the hypothesis is being tested that bortezomib is able to increase duration of response and thus improving survival. This hypothesis is based on the results of the approval study where bortezomib has been tested to improve these endpoints.This is a multicenter, open-label, randomized (patients are assigned to different treatment group by chance) phase III study to evaluate the efficacy and safety of a consolidation therapy with bortezomib in patients with multiple myeloma aged 61 to 75. Three months after receiving high dose melphalan with autologous stem cell transplantation patients will be randomized to receive either consolidation therapy with bortezomib or to be monitored without consolidation therapy. Subjects in the consolidation group will be treated up to 4 cycles (6 weeks each). The main study phase has a duration of 24 weeks. The trial ends after the last enrolled patient has completed a follow-up period of 30 months. The primary objective is to determine the event free survival in treatment and observation group. The secondary objectives are to assess the response rate, overall survival, duration of response, time to progression, short- and long-term toxicities, quality of life and cytogenetic analyses with regard to treatment response, event free survival and overall survival. Primary efficacy analysis: Event free survival is defined as the time from the first disease-related therapeutic procedure until death, progress or relapse. Secondary efficacy analyses: response rate of the treatment group (measured by the relative change of M-protein levels in serum or urine); overall survival is defined as the time from the first therapeutic procedure until death; time to progression is defined as the duration from the date of enrolment until the date of first documented evidence of progressive disease or relapse; duration of response is defined as the duration in months from the date of first evidence of confirmed response to the date of first documented evidence of progressive disease or relapse; quality of life is assessed by the questionnaires EORTC QLQ-C30 (Quality of life questionnaire) and EORTC EQ-5D (Euro Quality of life). Consolidation therapy lasts 4 cycles. Subjects will be treated with bortezomib 1.6 mg/m2 body surface intravenously once weekly for 4 weeks (Days 1, 8, 15, and 22) followed by a 13-day rest period (days 23 to 35). At least 72 hours should relapse between consecutive doses of bortezomib. Therapy should be withheld at the onset of any Grade 3 nonhematological or Grade 4 hematological toxicities excluding neuropathy.

Being tested
Bortezomib
Keywords
Multiple Myeloma, Clinical trial, 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

    1.6 mg/m2 i.v. d1 d8 d15 d22 for 4 cycles each of 35 days

Study groups in NCT00416208
Study groupRoleWhat they receive
BortezomibExperimentalBortezomib 1.6 mg/m2 i.v. d1 d8 d15 d22 for 4 cycles each of 35 days
Receives: Drug: Bortezomib
ObservationNo interventionObservational arm

What is being measured

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

  1. The difference in event-free survival time will be compared between both arms

    Measured: Every 35 days during treatment phase, after 4, 8, 12, 18, 24 months during follow-up

Secondary outcomes (1)

  1. Best response to chemotherapy, response rate to chemotherapy , duration of response, toxicities and quality of life; timepoints for assessments will be at end of study, at 1,5 + 4 + 8 +12 + 18 + 24 + 30 months and thereafter 6 monthly

    Measured: Every 35 days during treatment phase, after 4, 8, 12, 18, 24 months during follow-up

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 startOct 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
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00416208
Sponsor's protocol ID
CR006127
Other IDs
26866138MMY3013
Status last verified
Mar 2015
First submitted
22 Dec 2006
Last updated
5 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 37 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 4 inclusion and 9 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 5 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 37 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?

The difference in event-free survival time will be compared between both arms (time frame: Every 35 days during treatment phase, after 4, 8, 12, 18, 24 months during follow-up). 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 NCT00416208, 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 5 Mar 2015.

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