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Multiple MyelomaPhase 2/3NCT00657488

Thalidomide 100 mg/Day Versus Thalidomide 400 mg/Day in Relapse Refractory Multiple Myeloma

A Phase 2/3 study testing Thalidomide in people with Multiple Myeloma, run by Celgene at 49 sites in 2 countries.

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 objective of this study is to show that thalidomide at a dose of 100 mg/d (with remedial treatment with dexamethasone if a progression occurs) is equivalent in terms of efficacy with thalidomide at 400 mg/d (with remedial treatment with dexamethasone if a progression occurs) in the treatment of refractory or… 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?
Thalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
49 sitesin 2 countries
Study dates
1 Dec 2001to 1 Apr 2006
Phase
Phase 2/3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient over 18 years who has been informed about the potential risks and side effects of the treatment and having signed an informed consent to take part in the various aspects of the study.
  • Having a refractory or relapsed multiple myeloma after at least two courses of treatment.
  • The patients with a refractory or relapsed multiple myeloma after a single course of treatment that included an alkylating drug, can be included if there is no alternative treatment.
  • Concerning the thalidomide: Agreement to use and introduction of effective contraception by all the patients:
  • For women of childbearing potential
  • Oral estroprogestogen contraception introduced at least 1 month before the first administration of thalidomide, and continued until the first menstruation following the end of the treatment, and their partners use a condom.
Show all 17Show fewer
  • Qualitative serum test for beta-HCG negative: to be done on Day 2 or 3 of the menstrual cycle just before the 1st prescription of thalidomide; in a context of spaniomenorrhea or amenorrhea the test should be done within 3 days after the 1st prescription of thalidomide.
  • For post-menopausal women
  • 1st situation: Known sterility due to:
  • total hysterectomy;
  • total ovariectomy;
  • total salpingectomy
  • 2nd situation: Natural menopause
  • amenorrhea for at least 1 year and
  • negative progestagen test and
  • plasma FSH > 50 IU/l
  • For men: Throughout the duration of the treatment and for 3 months after the end of the protocol (i.e. one spermatogenesis cycle), sexual intercourse must always be protected by using a condom.

Who cannot join

  • Pregnant or breast-feeding women or those of childbearing potential who are not using an effective method of contraception or the lack of protection during sexual intercourse in men.
  • Patients who have already received treatment with thalidomide.
  • Contraindication to thalidomide.
  • Patient who has an absolute contraindication to dexamethasone.
  • Patient with a history of deep vein thrombosis and who is not taking effective oral anticoagulation (the anticoagulant must be continued throughout the entire study).
  • Performance index more than or equal to 3, unless the patient is bedridden as a result of the progress of the myeloma.
  • Any situations that do not permit adequate follow-up of the study.

Trial locations and contacts

49 sites in 2 countries.

49 sites in 2 countries

France47 sites

  • Chu D'Angers - Medecine D

    Angers, 49100

  • Centre Hospitalier D'Annecy - Service d'oncohématologie

    Annecy, 74011

  • Centre Hospitalier H. Duffaut - Hematologie

    Avignon, 84902

  • HOPITAL JEAN MINJOZ - Médecine interne/Hématologie

    Besançon, 25030

  • Centre Hospitalier de Blois - Unité d'Onco-Hématologie

    Blois, 41016

  • Hopital Avicenne - Medecine Interne/Hematologie

    Bobigny, 93009

  • Centre Hospitalier Du Dr Duschene - Hematologie

    Boulogne-sur-Mer, 62321

  • Hopital Morvan - Service Hematologie

    Brest, 29609

  • Polyclinique Du Parc - Hematologie

    Caen, 14052

  • Centre François Baclesse

    Caen, 14076

  • Centre Hospitalier - Service Hematologie

    Chambéry, 73011

  • H.I.A. Percy Hematologie

    Clamart, 92141

  • Centre Hospitalier General - Medecine Interne

    Dunkirk, 59385

  • Hopital Albert Michallon - Hematologie

    Grenoble, 38043

  • CENTRE HOSPITALIER DEPARTEMENTAL - Sce Médecine A

    La Roche-sur-Yon, 85025

  • Centre Hospitalier La Rochelle - Unité d'Oncologie Médicale

    La Rochelle, 17019

  • Centre Hospitalier - Service de Médecine 7

    Laval, 53015

  • Clinique Victor Hugo

    Le Mans, 72015

  • CHRU CLAUDE HURIEZ - Maladies du sang

    Lille, 59037

  • Chu Edouard Herriot

    Lyon, 69437

  • INSTITUT PAOLI CALMETTE - Unité transplantation

    Marseille, 13272

  • CHR Hôp N.D. de Bon Secours - Service de Médecine A

    Metz, 57038

  • Hopital Jacques Monod - Rhumatologie

    Montivilliers, 76290

  • CHRU Hôtel Dieu, Service des Maladies du Sang

    Nantes, 44035

  • Centre Lacassagne

    Nice, 06050

  • Institut Curie - Service d'hématologie

    Paris, 75248

  • HOPITAL ST ANTOINE - Maladies du Sang

    Paris, 75571

  • Centre Hospitalier Général - Service d'Hématologie

    Perpignan, 66046

  • Hopital Du Haut Leveque - Hematologie

    Pessac, 33604

  • Centre Hospitalier de Lyon Sud

    Pierre-Bénite, 69945

  • CHRU Jean Bernard - Hématologie

    Poitiers, 86021

  • Centre Hospitalier Laennec - Service de Médecine A

    Quimper, 29107

  • Hôpital Robert Debré - Hématologie

    Reims, 51032

  • C.H.R. de Pontchaillou - Hématologie

    Rennes, 35033

  • CHRU Hôpital Sud - Médecine Interne

    Rennes, 35056

  • Centre Henri Becquerel - Service Hématologie

    Rouen, 76038

  • C.H.U. de Saint Etienne - Hôpital Bellevue - Sce Rhumatologie

    Saint-Etienne, 42055

  • Hôpital Nord - Hématologie

    Saint-Etienne, 42055

  • CHU Hautepierre - Service Hématologie

    Strasbourg, 67000

  • HOPITAL HAUTEPIERRE - Service Rhumatologie

    Strasbourg, 67098

  • C.H.U. Rangueil - Service Rhumatologie

    Toulouse, 31054

  • C.H.U. PURPAN - Service Hématologie

    Toulouse, 31059

  • C.H.U. Bretonneau

    Tours, 37044

  • Centre Hospitalier - Service de Rhumatologie

    Tulle, 19012

  • Centre Hospitalier - Hématologie

    Valence, 26953

  • CHU Hôpital Brabois - Médecine interne-Hématologie

    Vandœuvre-lès-Nancy, 54511

  • Centre Hospitalier Chubert - Médecine Interne

    Vannes, 56017

Other trials in France

Belgium2 sites

  • Hopital St Joseph

    Gilly, 6060

  • UCL de Mont Godine

    Yvoir, 5530

Other trials in Belgium

About this study

Official title: Multicenter, Randomized Study Comparing the Efficacy and Safety of Two Doses of Thalidomide (100 mg/Day Versus 400 mg/Day) in the Treatment of Subjects With Refractory or Relapsed Multiple Myeloma.

The objective of this study is to show that thalidomide at a dose of 100 mg/d (with remedial treatment with dexamethasone if a progression occurs) is equivalent in terms of efficacy with thalidomide at 400 mg/d (with remedial treatment with dexamethasone if a progression occurs) in the treatment of refractory or relapsed multiple myeloma after at least two courses of treatment. The use of thalidomide at 100 mg/d should reduce the side effects and improve the safety of the treatment.

Being tested
Thalidomide
Keywords
Multiple Myeloma, Thalidomide, dose, dexamethasone
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 THALOMID

    Thalidomide 100mg/day or 400 mg/day at bed time during one year

Study groups in NCT00657488
Study groupRoleWhat they receive
AExperimentalThalidomide 100mg/day. Dexamethasone is administered at a dose of 40 mg/d, on 4 consecutive days (D1 - D4), with one course every four week in case of stable disease after 12 weeks of treatment or in case of Disease Progression
Receives: Drug: Thalidomide
BActive comparatorThalidomide 400mg/day. Dexamethasone is administered at a dose of 40 mg/d, on 4 consecutive days (D1 - D4), with one course every four week in case of stable disease after 12 weeks of treatment or in case of Disease Progression
Receives: Drug: Thalidomide

What is being measured

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

  1. all cause mortality

    Measured: one year

Secondary outcomes (1)

  1. response rate

    Measured: monthly

Timeline

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

  1. First posted14 Apr 2008 (estimated)
  2. Study start1 Dec 2001
  3. Primary completion1 Oct 2005
  4. Study completion1 Apr 2006

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00657488
Sponsor's protocol ID
LATH0102/IFM0102
Status last verified
Oct 2019
First submitted
7 Apr 2008
Last updated
18 Oct 2019
Results posted
No
Data monitoring committee
No

Publications

  • Yakoub-Agha I, Mary JY, Hulin C, Doyen C, Marit G, Benboubker L, Voillat L, Moreau P, Berthou C, Stoppa AM, Maloisel F, Rodon P, Dib M, Pegourie B, Casassus P, Slama B, Damaj G, Zerbib R, Harousseau JL, Mohty M, Facon T; Intergroupe Francophone du Myelome (IFM). Low-dose vs. high-dose thalidomide for advanced multiple myeloma: a prospective trial from the Intergroupe Francophone du Myelome. Eur J Haematol. 2012 Mar;88(3):249-59. doi: 10.1111/j.1600-0609.2011.01729.x. Epub 2012 Jan 4.

    PubMed 22023551

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Thalidomide in people with Multiple Myeloma, run by Celgene at 49 sites in 2 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 17 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 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in France, Belgium. 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 combined 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.

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?

all cause mortality (time frame: one year). 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 NCT00657488, 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 18 Oct 2019.

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