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

October 16, 2019 updated by: Celgene

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gilly, Belgium, 6060
        • Hôpital St Joseph
      • Yvoir, Belgium, 5530
        • UCL de Mont Godine
  • France
      • Angers, France, 49100
        • Chu D'Angers - Medecine D
      • Annecy, France, 74011
        • Centre Hospitalier D'Annecy - Service d'oncohématologie
      • Avignon, France, 84902
        • Centre Hospitalier H. Duffaut - Hematologie
      • Besancon, France, 25030
        • HOPITAL JEAN MINJOZ - Médecine interne/Hématologie
      • Blois, France, 41016
        • Centre Hospitalier de Blois - Unité d'Onco-Hématologie
      • Bobigny, France, 93009
        • Hopital Avicenne - Medecine Interne/Hematologie
      • Boulogne Sur Mer, France, 62321
        • Centre Hospitalier Du Dr Duschene - Hematologie
      • Brest, France, 29609
        • Hopital Morvan - Service Hematologie
      • Caen, France, 14076
        • Centre Francois Baclesse
      • Caen, France, 14052
        • Polyclinique Du Parc - Hematologie
      • Chambery, France, 73011
        • Centre Hospitalier - Service Hematologie
      • Clamart, France, 92141
        • H.I.A. Percy Hematologie
      • Dunkerque, France, 59385
        • Centre Hospitalier General - Medecine Interne
      • Grenoble, France, 38043
        • Hopital Albert Michallon - Hematologie
      • La Roche Sur Yon, France, 85025
        • CENTRE HOSPITALIER DEPARTEMENTAL - Sce Médecine A
      • La Rochelle, France, 17019
        • Centre Hospitalier La Rochelle - Unité d'Oncologie Médicale
      • Laval, France, 53015
        • Centre Hospitalier - Service de Médecine 7
      • Le Mans, France, 72015
        • Clinique Victor Hugo
      • Lille, France, 59037
        • CHRU CLAUDE HURIEZ - Maladies du sang
      • Lyon, France, 69437
        • Chu Edouard Herriot
      • Marseille, France, 13272
        • INSTITUT PAOLI CALMETTE - Unité transplantation
      • Metz, France, 57038
        • CHR Hôp N.D. de Bon Secours - Service de Médecine A
      • Montivilliers, France, 76290
        • Hopital Jacques Monod - Rhumatologie
      • Nantes, France, 44035
        • CHRU Hôtel Dieu, Service des Maladies du Sang
      • Nice, France, 06050
        • Centre Lacassagne
      • Paris, France, 75248
        • Institut Curie - Service d'hématologie
      • Paris, France, 75571
        • HOPITAL ST ANTOINE - Maladies du Sang
      • Perpignan, France, 66046
        • Centre Hospitalier Général - Service d'Hématologie
      • Pessac, France, 33604
        • Hopital Du Haut Leveque - Hematologie
      • Pierre Benite, France, 69945
        • Centre Hospitalier de Lyon Sud
      • Poitiers, France, 86021
        • CHRU Jean Bernard - Hématologie
      • Quimper, France, 29107
        • Centre Hospitalier Laennec - Service de Médecine A
      • Reims, France, 51032
        • Hôpital Robert Debré - Hématologie
      • Rennes, France, 35033
        • C.H.R. de Pontchaillou - Hématologie
      • Rennes, France, 35056
        • CHRU Hôpital Sud - Médecine Interne
      • Rouen, France, 76038
        • CENTRE HENRI BECQUEREL - Service Hématologie
      • Saint Etienne, France, 42055
        • C.H.U. de Saint Etienne - Hôpital Bellevue - Sce Rhumatologie
      • Saint Etienne, France, 42055
        • Hôpital Nord - Hématologie
      • Strasbourg, France, 67000
        • CHU Hautepierre - Service Hématologie
      • Strasbourg, France, 67098
        • HOPITAL HAUTEPIERRE - Service Rhumatologie
      • Toulouse, France, 31054
        • C.H.U. Rangueil - Service Rhumatologie
      • Toulouse, France, 31059
        • C.H.U. PURPAN - Service Hématologie
      • Tours, France, 37044
        • C.H.U. Bretonneau
      • Tulle, France, 19012
        • Centre Hospitalier - Service de Rhumatologie
      • Valence, France, 26953
        • Centre Hospitalier - Hématologie
      • Vandoeuvre Les Nancy, France, 54511
        • CHU Hôpital Brabois - Médecine interne-Hématologie
      • Vannes, France, 56017
        • Centre Hospitalier Chubert - Médecine Interne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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:

    1. 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.
      • 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.

    2. 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
    3. 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: A
Thalidomide 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
Drug: Thalidomide
Thalidomide 100mg/day or 400 mg/day at bed time during one year
Other Names:
  • THALOMID
Active Comparator: B
Thalidomide 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
Drug: Thalidomide
Thalidomide 100mg/day or 400 mg/day at bed time during one year
Other Names:
  • THALOMID

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
all cause mortality
Time Frame: one year
one year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
response rate
Time Frame: monthly
monthly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Celgene

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ibrahim YAKOUB-AGHA, MD, Chru Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2001

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2005

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2006

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LATH0102/IFM0102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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