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Stem cell transplant vs. drugs: which works better for younger myeloma patients?

NCT ID NCT01191060

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 700 adults up to age 65 with multiple myeloma to see if high-dose therapy with a stem cell transplant works better than standard drug therapy (lenalidomide, bortezomib, and dexamethasone). The goal was to find out which approach delays the cancer from growing longer. Participants were randomly assigned to one of the two treatments and followed for up to 4 years.

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

700 people

The number who actually took part.

Started

Oct 2010

Finished

Nov 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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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 for registration : (with labs performed within 21 days of initiation of protocol therapy): * Patients diagnosed with multiple myeloma based on International Myeloma Foundation 2003 Diagnostic Criteria. * Patients must have symptomatic myeloma with myeloma-related organ damage. * Patients must have myeloma that is measurable by either serum or urine evaluation of the monoclonal component or by assay of serum free light chains. * Age between 18 and 65 years at the time of signing the informed consent document. * ECOG performance status \<2 (Karnofsky ≥ 60%) * Negative HIV blood test Exclusion Criteria for registration (section 4.2): * Participants must not have been treated with any prior systemic therapy for multiple myeloma. Treatment by localized radiotherapy is not an exclusion criterion if an interval of at least two weeks between the end of radiotherapy and initiation of protocol therapy entry in the study is observed. Similarly, the dose of corticosteroids received by the participant should not exceed the equivalent of 160 mg of dexamethasone over a two-week period before initiation of protocol therapy. * Primary amyloidosis (AL) or myeloma complicated by amylosis. * Participants may not be receiving any other study investigational agents. * Participants with known brain metastases * Poor tolerability or known allergy to any of the study drugs or compounds of similar chemical or biologic composition to study agents * Platelet count \< 50,000/mm3 per µLwithin 21 days of initiation of protocol therapy. Transfusion within 7 days of screening is not allowed to meet platelet eligibility criteria. * ANC \< 1,000 cells/mm3 within 21 days of initiation of protocol therapy. Growth factor within 7 days of screening is not allowed to meet ANC eligibility criteria. * Hemoglobin \< 8.0 g/dL within 21 days of initiation of protocol therapy. Transfusion may be used to meet hemoglobin eligibility criteria. * Hepatic impairment, defined a bilirubin \> 1.5 x institutional upper limit of normal (ULN) \> 2 mg/dL (Patients with benign hyperbilirubinemia (e.g., Gilbert's syndrome) are eligible) and or AST (SGOT), or ALT (SGPT), or alkaline phosphatase \> 2 x ULN * Renal insufficiency, defined as serum creatinine \> 2.5 mg/dl and/or creatinine clearance \< \<40 60 ml/min (actual or calculated). The Cockgroft-Gault formula should be used for calculating creatinine clearance values, and may be located in Section 4.2 * Respiratory compromise, defined as ventilation tests and with DLCO \< 50% * Participant must not demonstrate with clinical signs of heart or coronary failure, or evidence of LVEF \< 40%. Participant must not have with myocardial infarction within 6 months prior to enrollment or have New York Heart Association (NYHA Appendix VII) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant. * Intercurrent illness including, but not limited to ongoing or active severe infection, known (active or not) infection with hepatitis B or C virus, poorly controlled diabetes, severe uncontrolled psychiatric disorder or psychiatric illness/social situations that would limit compliance with study requirements. * Participant with previous history of another malignant condition, except for basal cell carcinoma and stage I cervical cancer * Female participant who is pregnant or breast-feeding * Inability to comply with an anti-thrombotic treatment regimen * Peripheral neuropathy ≥ Grade 2 peripheral neuropathy on clinical examination within 21 days of initiation of protocol therapy * Mental illness likely to interfere with participation in the study and Adults under juridical protection

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Conditions

The condition(s) this trial relates to.

Disease Progression 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

  • CH Bretagne Atlantique Vannes et Auray

    Vannes, 56017, France

  • CH Chambéry

    Chambéry, 73011, France

  • CH Louis Pasteur - Colmar

    Colmar, 68024, France

  • CH Meaux

    Meaux, 77104, France

  • CH René Dubos

    Cergy-Pontoise, 95303, France

  • CH Saint Jean

    Perpignan, 66046, France

  • CH Sud Francilien

    Corbeil-Essonnes, 91106, France

  • CH de Chartres - Hôpital Louis Pasteur

    Le Coudray, 26630, France

  • CH du Pays D'Aix

    Aix-en-Provence, 13 616, France

  • CHRU - Hôpital Bretonneau

    Tours, 37044, France

  • CHRU - Hôpital Claude Huriez

    Lille, 59037, France

  • CHRU - Hôpital Jean Bernard

    Poitiers, 86021, France

  • CHRU - Hôpital Sud

    Rennes, 35056, France

  • CHRU - Hôpital Sud Amiens

    Amiens, 80054, France

  • CHRU - Hôpital de Pontchaillou

    Rennes, 35033, France

  • CHRU - Hôpital du Haut Lévêque

    Pessac, 33604, France

  • CHRU - Hôtel Dieu

    Nantes, 44093, France

  • CHRU Dijon

    Dijon, 21000, France

  • CHU - Hôpital Edouard Herriot

    Lyon, 69437, France

  • CHU Caen Côte de Nacre

    Caen, 14033, France

  • CHU Henri Mondor

    Créteil, 94 010, France

  • CHU d'Angers

    Angers, 49033, France

  • CHU d'Estaing

    Clermont-Ferrand, 63000, France

  • CHU de Limoges

    Limoges, 87042, France

  • Centre Catherine de Sienne

    Nantes, 44 202, France

  • Centre François Baclesse

    Caen, 14076, France

  • Centre Henri Becquerel

    Rouen, 76038, France

  • Centre Hospitalier Argenteuil Victor Dupouy

    Argenteuil, 95 100, France

  • Centre Hospitalier Départemental - La réunion St Denis

    Saint-Denis, 97 405, France

  • Centre Hospitalier Général - Dunkerque

    Dunkirk, 59 385, France

  • Centre Hospitalier H.Duffaut

    Avignon, 84902, France

  • Centre Hospitalier Lyon sud

    Pierre-Bénite, 69495, France

  • Centre Hospitalier William Morey

    Chalon-sur-Saône, 71 321, France

  • Centre Hospitalier Yves le Foll

    Saint-Brieuc, 22 027, France

  • Centre Hospitalier de Blois

    Blois, 41016, France

  • Centre Hospitalier de Valence

    Valence, 26953, France

  • Centre Hospitalier de la côte basque

    Bayonne, 64109, France

  • Centre Hospitalier de la région d'Annecy

    Pringy, 74374, France

  • Centre Jean Bernard

    Le Mans, 72000, France

  • Centre Léon Bérard

    Lyon, France

  • Centre René Huguenin

    Saint-Cloud, 92210, France

  • Centre hospitalier Bodelio

    Lorient, 56322, France

  • Centre hospitalier Le Mans

    Le Mans, 72037, France

  • Centre hospitalier départemental - La Roche sur Yon cedex

    La Roche-sur-Yon, 85025, France

  • Groupe Hospitalier Sud Réunion

    Saint-Pierre, 97448, France

  • Groupe Hospitalo-Universitaire Carémeau

    Nîmes Cédex 9, 30029, France

  • Hopital E Muller

    Mulhouse, 68100, France

  • Hôpital A.Michallon

    Grenoble, 38043, France

  • Hôpital A.Morvan

    Brest, 29609, France

  • Hôpital Antoine Béclère

    Clamart, 92 141, France

  • Hôpital Archet 1

    Nice, 06202, France

  • Hôpital Avicenne

    Bobigny, 93009, France

  • Hôpital Cochin

    Paris, 75014, France

  • Hôpital Jean Minjoz

    Besançon, 25030, France

  • Hôpital R.Debré

    Reims, 51092, France

  • Hôpital Saint-Louis

    Paris, 75475, France

  • Hôpital St-Antoine

    Paris, 75571, France

  • Hôpital d'instruction des armées Percy

    Clamart, 92141, France

  • Hôpital de l'Archet

    Nice, 06202, France

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67091, France

  • Hôpitaux de Brabois

    Nancy, 54511, France

  • Institut Curie

    Paris, 75005, France

  • Institut Gustave Roussy

    Villejuif, 94 805, France

  • Institut Paoli Calmettes

    Marseille, 13273, France

  • Institut de Cancérologie de la Loire

    Saint-Priest-en-Jarez, 42 271, France

  • Pole Santé République

    Clermont-Ferrand, 63050, France

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33 300, France

  • University Hospital of Toulouse, Purpan

    Toulouse, 31059 Cedex 9, France

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Other studies related to the condition(s) this trial covers.