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Which drug cocktail best primes myeloma for transplant?

NCT ID NCT01971658

Disease control Sponsor: Nantes University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers compare two three-drug combinations, VTD and VCD, as initial treatment for people newly diagnosed with multiple myeloma who are eligible for a stem cell transplant. Participants receive four cycles of either combination. The trial measures how well each combination reduces cancer before transplant, aiming to see which leads to deeper remissions.

What this could mean

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

Active substance
Two drug combinations: bortezomib, thalidomide, and dexamethasone (VTD) versus bortezomib, cyclophosphamide, and dexamethasone (VCD)
What this could lead to
If one combination works better, doctors could choose it more often to shrink myeloma before a stem cell transplant, possibly improving remission rates.
What could go wrong
Both combinations can cause side effects like nerve damage, fatigue, or low blood counts. The trial may not show a clear winner, and results might not apply to all patients.

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

358 people

The number who actually took part.

Start date

Oct 2013

Finished

Aug 2015

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: Patients newly diagnosed with symptomatic Multiple Myeloma (MM) patient 1. \- 18 ≤ age \< 66 years 2. \- Eastern Cooperative Oncology Group Performance Status of 0, 1 or 2 3. \- Patients must be eligible for Autologous Stem Cell Transplantation 4. \- Patients must have measurable disease by serum M-protein ≥ 10 g/L and/or urine M-protein ≥200mg/day 5. \- Female patients of child-bearing potential (FCBP): * Must agree to have medically supervised pregnancy tests prior to starting study and every 21 days, including 4 weeks after the end of study treatment. This applies even if the patient practices complete and continued sexual abstinence. * Must agree to use and be able to comply with effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including during periods of dose interruptions), and for 28 days after discontinuation of study therapy. 6. \- Male Patients: * Must agree to use a condom during sexual contact with a FCBP, throughout study drug therapy, during any dose interruption and for one week after discontinuation of study therapy * Must agree to not donate semen during study drug therapy and for one week after discontinuation of study therapy 7. \- All patients must: * Agree to abstain from donating blood while taking study drug therapy and for one week after discontinuation of study drug therapy * Agree not to share study medication with another person. 8. \- Patients must be capable of giving informed consent 9. \- Patients must be affiliated with French social security system Exclusion Criteria: 1. \- Asymptomatic Multiple myeloma 2. \- Non-secretory Multiple myeloma 3. \- Proven AL-amyloidosis 4. \- Age ≥ 66 years old 5. \- Prior or current systemic therapy for Multiple myeloma, including steroids (except for emergency use of a 4-day block of dexamethasone before randomization, maximum total dose allowed 160 mg) 6. \- Radiation therapy in the 2 weeks preceding randomization 7. \- National Cancer Institute grade ≥ 2 peripheral neuropathy 8. \- Haemoglobin \< 8g/dL 9. \- Absolute neutrophil count \< 1,000 cells / µL, platelet count \< 50,000 cells / µL 10. \- Creatinine level \> 170 µmol/L or requiring dialysis. 11. \- Bilirubin, transaminases or GamaGT \> 3 UNL (upper normal limit) 12. \- Positive HIV serology, evidence of active Hepatitis B and C infection 13. \- Severe active infection 14. \- Inability to comply with an anti-thrombotic treatment regimen 15. \- A personal medical history of severe psychiatric disease 16. \- Uncontrolled diabetes contraindicating the use of high-dose dexamethasone 17. \- Non-controlled or severe cardiovascular disease (including a myocardial infarction in the 6 months prior to recruitment) 18. \- A personal medical history of cancer unless the patient has been without relapse after treatment discontinuation \> or = 5 years (except for basocellular skin cancer or in situ cervical cancer) 19. \- Use of any investigational drug in the 30 days preceding randomization 22 - Pregnant or lactating women. 23 - Adults under juridical protection 24 - Known or suspected hypersensitivity to any of the study therapies or excipients 25 - Necessity of vaccination for yellow fever or with any other live vaccines

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

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

Multiple myeloma

Contacts and locations

Locations

  • AP-HP Hôpital Necker

    Paris, 75743, France

  • CH Bretagne Atlantique Vannes et Auray

    Vannes, 56017, France

  • CH Le Mans

    Le Mans, 72000, France

  • CH René Dubos

    Cergy-Pontoise, 95303, France

  • CH Saint Jean

    Perpignan, 66046, France

  • CHR Metz Thionville

    Metz, 57085, France

  • CHRU - Hôpital A.Michallon

    Grenoble, 38043, France

  • CHRU - Hôpital Bretonneau

    Tours, 37044, France

  • CHRU - Hôpital Claude Huriez

    Lille, 59037, France

  • CHRU - Hôpital Jean Bernard

    Poitiers, 86021, France

  • CHRU - Hôpital Purpan

    Toulouse, 31059, France

  • CHRU - Hôpital de Pontchaillou

    Rennes, 35033, France

  • CHRU - Hôpital du Haut Lévêque

    Pessac, 33604, France

  • CHRU - Hôpitaux de Brabois

    Vandœuvre-lès-Nancy, 54511, France

  • CHRU Dijon

    Dijon, 21000, France

  • CHRU Hôpital Sud

    Amiens, 80054, France

  • CHRU de Besançon

    Besançon, 25030, France

  • CHU - Hôpital St-Antoine

    Paris, 75571, France

  • CHU Angers

    Angers, 49033, France

  • CHU Caen Côte de Nacre

    Caen, 14033, France

  • CHU Henri Mondor

    Créteil, 94 010, France

  • CHU d'Estaing

    Clermont-Ferrand, 63000, France

  • CHU de Limoges

    Limoges, 87042, France

  • Centre Henri Becquerel

    Rouen, 76038, France

  • Centre Hospitalier

    Saint-Quentin, 02 321, France

  • Centre Hospitalier Argenteuil

    Argenteuil, 95 100, France

  • Centre Hospitalier Général

    Dunkirk, 59 385, France

  • Centre Hospitalier H.Duffaut

    Avignon, 84902, France

  • Centre Hospitalier Lyon sud

    Pierre-Bénite, 69495, France

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, 91100, France

  • Centre Hospitalier William Morey

    Chalon/saone, 71 321, France

  • Centre Hospitalier Yves le Foll

    Saint-Brieuc, 22 027, France

  • Centre Hospitalier de Meaux

    Meaux, 77104, France

  • Centre Hospitalier de PERIGUEUX

    Périgueux, 24000, France

  • Centre Hospitalier de la Côte Basque

    Bayonne, 64109, France

  • Centre Hospitalier de la région d'Annecy

    Annecy, Pringy, 74374, France

  • Centre Hospitalier intercommunale Meulan les mureaux

    Meulan-en-Yvelines, 78250, France

  • Centre Jean Bernard

    Le Mans, 72000, France

  • Centre Léon Bérard

    Lyon, 69008, France

  • Centre René Huguenin

    Saint-Cloud, 92210, France

  • Centre hospitalier

    St-Malo, 35400, France

  • Centre hospitalier Pierre Oudot

    Bourgoin, 38300, France

  • Centre hospitalier départemental Vendée

    La Roche-sur-Yon, 85925, France

  • Groupe Hospitalo-Universitaire Carémeau

    Nîmes, 30029, France

  • Hopital E Muller

    Mulhouse, 68100, France

  • Hopital Saint Vincent de Paul

    Lille, 59020, France

  • Hôpital A.Morvan

    Brest, 29609, France

  • Hôpital Avicenne

    Bobigny, 93009, France

  • Hôpital Cochin

    Paris, 75014, France

  • Hôpital Du Scorff

    Lorient, 56100, France

  • Hôpital Louis Pasteur

    Le Coudray, 28000, France

  • Hôpital Pitié-Salpétrière

    Paris, 75651, France

  • Hôpital R.Debré

    Reims, 51092, France

  • Hôpital d'instruction des armées Percy

    Clamart, 92141, France

  • Hôpital de l'Archet 1

    Nice, 06202, France

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67091, France

  • Hôpitaux civils de Colmar

    Colmar, 68024, France

  • Institut CURIE

    Paris, 75005, France

  • Institut Paoli Calmettes

    Marseille, 13273, France

  • Institut de Cancérologie de la Loire

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

  • Nantes University Hospital

    Nantes, 44093, France

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33 300, France

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