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Multiple MyelomaPhase 3NCT00218855

Thalidomide to Patients With Previously Untreated Multiple Myeloma

A Phase 3 study testing thalidomide in people with Multiple Myeloma, run by Norwegian University of Science and Technology at 1 site in Norway.

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 test the effect of thalidomide in patients with multiple myeloma. The patients receive either thalidomide or a placebo tablet (neither patient nor doctor know which of these are given) in addition to the ordinary chemotherapeutic drug against multiple myeloma. Read more about this study

Who is it for?
Any age
Conditions the study is for
Multiple Myeloma
What is being tested?
thalidomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
363 participants
Where
1 siteNorway
Study dates
Jan 2002to Apr 2007
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients with multiple myeloma in need of treatment

Who cannot join

  • Previous treatment against multiple myeloma
  • Need of high dose chemotherapy with autologous stem cell support
  • Women in fertile age
  • Psychiatric disease or mental reduction leading to lack of cooperation
  • Lack of consent
  • Life expectancy below 3 months
  • Active cancer of other etiology

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Department of Haematology, St. Olavs hospital/NTNU

    Trondheim, N-7006

Other trials in Norway

About this study

Official title: A Phase 3 Study With Randomization to Melphalan/Prednisone/Thalidomide Versus Melphalan/Prednisone/Placebo to Patients With Previously Untreated Multiple Myeloma

The purpose of this study is to test the effect of thalidomide in patients with multiple myeloma. The patients receive either thalidomide or a placebo tablet (neither patient nor doctor know which of these are given) in addition to the ordinary chemotherapeutic drug against multiple myeloma. We will find out for how long time the patients will stay free of the disease and for how long time they will live, and can evaluate whether thalidomide is a beneficial drug against this disease.

Read the detailed description

Thalidomide has recently emerged as an effective treatment for patients with myeloma refractory to conventional chemotherapy. So far only limited experience is available on thalidomide for newly diagnosed myeloma. Therefore the Nordic Myeloma Study Group decided to perform a trial comparing traditional melphalan-prednisone therapy with melphalan-prednisone + thalidomide/placebo. The study design is a multicentre double-blind randomised placebo-controlled trial. Mainly patients >65 years of age will be included since patients <65 years will be treated with high dose chemotherapy with autologous stem cell support. The primary end-point is overall survival. Secondary end-points are quality of life, response rate, time to response, response duration and toxicity.

Being tested
thalidomide, placebo
Keywords
Multiple Myeloma, Phase 3, randomised, double blind study, thalidomide
Medical subject headings
Multiple Myeloma

What participants receive

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

  • thalidomideDrug

    Also called thalidomide, Talix

    tablets thalidomide start 100 mg x 2 escalating to 200 mg x 2 until plateau phase. Maintenance 100 mg x 2 until relapse. The same procedure is repeated by first relapse.

  • placeboDrug

    Also called no other names

    100 mg x 2 mg tablets escalating to 200 mg x 2 until plateau phase. Maintenance 100 mg x 2 until relapse. This procedure is repeated by first relapse.

Study groups in NCT00218855
Study groupRoleWhat they receive
APlacebo comparatorNot described
Receives: Drug: thalidomide; Drug: placebo
BActive comparatorNot described
Receives: Drug: thalidomide; Drug: placebo

What is being measured

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

  1. overall survival

    Measured: october 2007

Secondary outcomes (9)

  1. Quality of life

    Measured: october 2007

  2. Time to response

    Measured: october 2007

  3. Frequency of response

    Measured: october 2007

  4. Time to progression

    Measured: october 2007

  5. Time to 2. response

    Measured: october 2007

  6. Frequency of 2. response

    Measured: october 2007

  7. Time to 2. progression

    Measured: october 2007

  8. Toxicity

    Measured: october 2007

  9. Time to definitive treatment failure

    Measured: october 2007

Timeline

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

  1. First posted22 Sep 2005 (estimated)
  2. Study startJan 2002
  3. Primary completionApr 2007
  4. Study completionApr 2007

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
363 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00218855
Sponsor's protocol ID
NMSG #12
Other IDs
NFR 90000288
Status last verified
Mar 2014
First submitted
20 Sep 2005
Last updated
7 Mar 2014
Results posted
No
Data monitoring committee
No

Publications

  • Waage A, Gimsing P, Fayers P, Abildgaard N, Ahlberg L, Bjorkstrand B, Carlson K, Dahl IM, Forsberg K, Gulbrandsen N, Haukas E, Hjertner O, Hjorth M, Karlsson T, Knudsen LM, Nielsen JL, Linder O, Mellqvist UH, Nesthus I, Rolke J, Strandberg M, Sorbo JH, Wisloff F, Juliusson G, Turesson I; Nordic Myeloma Study Group. Melphalan and prednisone plus thalidomide or placebo in elderly patients with multiple myeloma. Blood. 2010 Sep 2;116(9):1405-12. doi: 10.1182/blood-2009-08-237974. Epub 2010 May 6.

    PubMed 20448107

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing thalidomide in people with Multiple Myeloma, run by Norwegian University of Science and Technology at 1 site in Norway.

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 1 inclusion and 7 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 7 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. 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. Some participants in this study may receive a placebo. 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?

overall survival (time frame: october 2007). 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 NCT00218855, 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 7 Mar 2014; AzTrials last refreshed its copy on 6 Nov 2026.

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