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Can lenalidomide keep myeloma at bay after transplant?

NCT ID NCT00430365

Disease control Sponsor: University Hospital, Toulouse Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tested whether taking lenalidomide (Revlimid) after an autologous stem cell transplant helps people with myeloma stay in remission longer. Over 600 participants under age 65 who had no signs of progression after transplant were randomly assigned to receive lenalidomide or a placebo. The study aimed to see if maintenance therapy could prolong the duration of response and improve survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lenalidomide (Revlimid)
What this could lead to
If successful, this could show that taking lenalidomide after a stem cell transplant helps keep myeloma under control for longer.
What could go wrong
This is a completed phase 3 trial, but results may not apply to all patients. Lenalidomide can have side effects like low blood counts and increased risk of infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

614 people

The number who actually took part.

Started

Jun 2006

Finished

Sep 2018

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * No signs of progression after transplant * Effective contraception if necessary (oral contraception for females and barrier methods of contraception for sexually active males) * No active severe infection * Satisfactory restoration of the haematological parameters defined by: PN \>1,000/mm3 and Platelets \> 75,000/mm3 * Bilirubin \< 35 umol/l and GOT/GPT/PAL\<3N * Creatinine \< 160 umol/l.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma plasma cell neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myeloma

Contacts and locations

Locations

  • Algemeen Centrumziekenhuis Antwerpen

    Antwerp, 2060, Belgium

  • CH

    Aix-en-Provence, 13616, France

  • CH

    Blois, 41016, France

  • CH

    Chartres, 28018, France

  • CH

    Le Mans, 72037, France

  • CH Chubert

    Vannes, 56017, France

  • CH Louis Pasteur

    Colmar, 68024, France

  • CH William Morey

    Châlon-sur-Saône, 71321, France

  • CHRU

    Amiens, 80054, France

  • CHRU Dijon

    Dijon, 21000, France

  • CHRU Hôpital Bretonneau

    Tours, 37044, France

  • CHRU Hôpital Claude Huriez

    Lille, 59037, France

  • CHRU Hôpital Jean Bernard

    Poitiers, 86021, France

  • CHRU Hôpital Michallon

    Grenoble, 38043, France

  • CHRU Hôpital Sud

    Rennes, 35056, France

  • CHRU Hôpital de Hautepierre

    Strasbourg, 67098, France

  • CHRU Hôpital de Pontchaillou

    Rennes, 35033, France

  • CHRU Hôpital du Bocage

    Angers, 49033, France

  • CHRU Hôpital haut Lévêque

    Bordeaux, 33604, France

  • CHRU Hôpitaux de Brabois

    Nancy, 54511, France

  • CHRU Hôtel Dieu

    Clermont-Ferrand, 63003, France

  • CHRU Hôtel Dieu

    Nantes, 44093, France

  • CHU Henri Mondor

    Créteil, 94010, France

  • CHU Hôpital Edouard Herriot

    Lyon, 69437, France

  • CHU Hôpital St Antoine

    Paris, 75571, France

  • CHU Toulouse Purpan

    Toulouse, France

  • CHU Toulouse Rangueil

    Toulouse, France

  • CHUV

    Lausanne, 1011, Switzerland

  • Center of Oncology/Hematology and transfusion Medicine, Kantonsspital

    Aarau, 5001, Switzerland

  • Centre Antoine Lacassagne

    Nice, 06050, France

  • Centre Baclesse

    Caen, 14076, France

  • Centre Henri Becquerel

    Rouen, 76038, France

  • Centre Léon Bérard

    Lyon, 69008, France

  • Centre hospitalier

    Troyes, 10003, France

  • Centre hospitalier Argenteuil Victor Dupouy

    Argenteuil, 95100, France

  • Centre hospitalier Bodelio

    Lorient, 56322, France

  • Centre hospitalier Duffaut

    Avignon, 84902, France

  • Centre hospitalier Lyon Sud

    Pierre-Bénite, 69495, France

  • Centre hospitalier Yves Le Foll

    Saint-Brieuc, 22027, France

  • Centre hospitalier de Roanne

    Roanne, 42328, France

  • Centre hospitalier de la Réunion

    Saint-Denis, 97405, France

  • Centre hospitalier de la côte basque

    Bayonne, 64109, France

  • Centre hospitalier de la région d'Annecy

    Pringy, 74374, France

  • Centre hospitalier départemental

    La Roche-sur-Yon, 85025, France

  • Centre hospitalier général

    Dunkirk, 59385, France

  • Heilig Hart Ziekenhuis

    Roeselare, 8800, Belgium

  • Hôpial Morvan

    Brest, 29609, France

  • Hôpital Antoine Béclère

    Clamart, 92141, France

  • Hôpital Archet

    Nice, 06202, France

  • Hôpital Avicenne

    Bobigny, 93009, France

  • Hôpital Cochin

    Paris, 75014, France

  • Hôpital Debré

    Reims, 51092, France

  • Hôpital Jean Minjoz

    Besançon, 25030, France

  • Hôpital Jolimont

    Haine-Saint-Paul, 7100, Belgium

  • Hôpital Nord

    Marseille, 13915, France

  • Hôpital Notre Dame de Bon Secours

    Metz, 57038, France

  • Hôpital Saint Joseph

    Arlon, 6700, Belgium

  • Hôpital Saint Joseph

    Gilly, 6060, Belgium

  • Hôpital cantonal

    Genêve, 1211, Switzerland

  • Hôpital d'instruction des Armées Percy

    Clamart, 92141, France

  • Hôpital de l'Archet

    Nice, 06202, France

  • Hôtel Dieu

    Paris, 75004, France

  • Inselspital

    Bern, 3010, Switzerland

  • Institut Jules Bordet

    Brussels, 1000, Belgium

  • Institut Paoli Calmette

    Marseille, 13273, France

  • Institut de Cancérologie de la Loire

    Saint-Priest-en-Jarez, 42271, France

  • Institute of Oncology and Hematology Stadtspital Triemli

    Zurich, 8063, Switzerland

  • Istituto Oncologico Sviss. Italiana IOSI Ospedale Regionale Bellinzona e Valli

    Bellinzona, 6500, Switzerland

  • Onkologie/Hämatologie Kantonsspital st Gallen

    Sankt Gallen, 9007, Switzerland

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33300, France

  • Polyclinique du Parc

    Caen, 14033, France

  • Spital Thun-Simmental Onkologiezentrum

    Thun, 3600, Switzerland

  • UCL Mont-Godinne

    Yvoir, 5530, Belgium

  • UCL St Luc

    Brussels, 1200, Belgium

  • UZA Antwerpen

    Antwerp, 2650, Belgium

  • Universitäts Spital

    Basel, 4031, Switzerland

  • ZNA Middelheim

    Antwerp, 2020, Belgium

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