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Multiple MyelomaPhase 2NCT00508209

Bortezomib and High-dose Melphalan at Myeloma Relapse

A Phase 2 study testing bortezomib in people with Multiple Myeloma, run by Nordic Myeloma Study Group at 9 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The prognosis after retreating with high-dose melphalan with stem cell support after first relapse after high-dose treatment is dependent on the time to first relapse. Bortezomib can increase chemosensitivity of e.g. melphalan. 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
How many people
50 participants
Where
9 sitesin 3 countries
Study dates
Jul 2007to Sep 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

  • First relapse after ASCT
  • Symptomatic myeloma
  • More than 2,0 x 10^6 CD34+ stem cells / kg bodyweight in the freezer for stem cell support
  • Signed informed consent given prior to any study related activities have been performed
  • Age > 18 years

Who cannot join

  • Allogeneic transplantation scheduled as a part of the treatment
  • Expected survival of less than one month.
  • Performance status (WHO) > 3
  • Neuropathy > Grade 3 (neurological symptoms interfering with ADL)
  • Non-secreting myeloma
  • Other concurrent disease making bortezomib treatment unsuitable
Show all 12Show fewer
  • Positive pregnancy test (only applicable for women with childbearing potential)
  • Has known or suspected hypersensitivity or intolerance to melphalan, dexamethasone, boron, mannitol, or heparin, if an indwelling catheter is used
  • Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure (Attachment 6, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
  • History of hypotension or has decreased blood pressure (sitting systolic blood pressure [SBP] <= 100 mmHg and/or sitting diastolic blood pressure [DBP] <= 60 mmHg)
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study
  • Have received an experimental drug or used an experimental medical device within 4 weeks prior to inclusion into the study

Trial locations and contacts

9 sites in 3 countries.

9 sites in 3 countries

Denmark4 sites

  • Department of Haematology B, Aalborg Hospital, University of Aarhus

    Aalborg, 9000

  • Dept. of Haematology, Århus University Hospital

    Aarhus, 8000

  • Department of Haematology, Herlev University Hospital

    Herlev, 2730

  • Department of Haematology X, Odense University Hospital

    Odense, 5000

Other trials in Denmark

Norway3 sites

  • Hematologisk seksjon, med avd, Haukeland Universitetssykehus

    Bergen, N-5021

  • Department of Hematology, Rikshospitalet

    Oslo

  • Hematologisk seksjon, St.Olav Hospital

    Trondheim, N-7006

Other trials in Norway

Sweden2 sites

  • Department of Hematology, Sahlgrenska Sjukhuset

    Gothenburg

  • University Hospital Lund

    Lund, SE-221 85

Other trials in Sweden

About this study

Official title: Phase II Study of Bortezomib Dexamethasone and High-dose Melphalan in Patients With Relapse After High-dose Melphalan With Autologous Stem Cell Support

The prognosis after retreating with high-dose melphalan with stem cell support after first relapse after high-dose treatment is dependent on the time to first relapse. Bortezomib can increase chemosensitivity of e.g. melphalan. The trial aims at determining the toxicity of adding bortezomib to high-dose melphalan with stem cell support and evaluating whether the time to a second relapse can be prolonged.

Read the detailed description

Patients with multiple myeloma who have their first treatment demanding relapse after an initial treatment with high-dose melphalan with autologous stem cell support and who have more than 2.0 x 10^6 CD34+ stem cells pr kg bodyweight in the freezer can be included in the trial.

After disease status with basic clinical biochemistry, M-protein in blood and urine, bone marrow investigation including immunophenotyping and total skeletal x-ray the patients are treated with three courses of standard bortezomib (1.3 mg/sqm Days 1,4,8,11) and dexamethasone 20 mg days 1,2,4,5,8,9,11,12. Within 4 weeks the patients receive bortezomib days -5 and -2, high-dose melphalan (200 mg/sqm) day -2, and subsequent at least 2.0 x 10^6 CD34+ stem cells pr kg body weight.

The first month after high-dose therapy the patients are followed closely for toxicity according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE), Version 3.0.

The patients are evaluated for response according to EBMT criteria and for event (death or progressive disease).

Being tested
bortezomib
Keywords
high-dose melphalan, bortezomib, response, toxicity, relapse
Medical subject headings
Multiple Myeloma, Recurrence

What participants receive

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

  • bortezomibDrug

    Also called Velcade

    1.3 mg/sqm days -5 and -2 in connection with high-dose melphalan (200mg/sqm day -2) and autologous stem cell support

What is being measured

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

  1. Comparison of the event free survival after first high-dose melphalan with stem cell support (ASCT) and a second ASCT combined with bortezomib treatment of first relapse

    Measured: 3 years

Secondary outcomes (4)

  1. Determining the toxicity of bortezomib as part of the high-dose melphalan conditioning

    Measured: 3 years

  2. Response rate of the second ASCT

    Measured: 3 years

  3. Marrow regeneration

    Measured: 3 years

  4. OS compared with the OS of matched controls from the former NMSG

    Measured: 3 years

Timeline

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

  1. First posted27 Jul 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionJun 2009
  4. Study completionSep 2010 (estimated)

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00508209
Sponsor's protocol ID
NMSG 16-07
Other IDs
EudraCT nr 2006-007022-64, KF 02 2006-7206, LMS 2612-3390
Status last verified
Jun 2010
First submitted
26 Jul 2007
Last updated
22 Jun 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bortezomib in people with Multiple Myeloma, run by Nordic Myeloma Study Group at 9 sites in 3 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 12 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: status not confirmed, as of the sponsor's last update on 22 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Denmark, Norway, Sweden. 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?

Results are not available in the source record.

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?

Comparison of the event free survival after first high-dose melphalan with stem cell support (ASCT) and a second ASCT combined with bortezomib treatment of first relapse (time frame: 3 years). 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 NCT00508209.

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 22 Jun 2010.

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