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New hope for rare leukemia: aggressive combo therapy shows promise

NCT ID NCT02858999

Disease control Sponsor: Centre Hospitalier Universitaire, Amiens 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 2 trial tested a powerful combination of chemotherapy drugs followed by stem cell transplants in 40 patients under 70 with primary plasma cell leukemia, a rare and aggressive blood cancer. The goal was to see if this intensive approach could improve how long patients live without the disease coming back. The study also collected blood and bone marrow samples to better understand the disease.

What this could mean

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

Active substance
combination chemotherapy (bortezomib, dexamethasone, doxorubicin, cyclophosphamide) followed by stem cell transplant
What this could lead to
If successful, this approach could improve disease-free survival and offer a more effective treatment strategy for this rare and aggressive blood cancer.
What could go wrong
This is a small, early-phase trial with only 40 participants, so results may not apply to all patients. The intensive treatment carries significant risks, including side effects from chemotherapy and transplant complications.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

40 people

The number who actually took part.

Start date

Jan 2010

Finished

Sep 2016

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 70 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: * Patient with primary plasma cell leukaemia corresponding to the International Myeloma Working Group definition. * Patient not previously treated apart from a short course of corticosteroid therapy (dexamethasone 40 mg/day for 4 days). * Age ≥ 18 years and \< 70 years. * Patient able to provide signed informed consent. * Effective contraception when justified (oral contraception/protected intercourse). Exclusion Criteria: * Consent not obtained. * Patient under judicial protection, or permanent or temporary guardianship. * Previously treated multiple myeloma, secondary plasma cell leukaemia. * ECOG performance status \> 2. * History of severe psychiatric illness, severe renal failure not attributable to PPL, heart failure (ejection fraction \< 40%), bilirubin \> 3N, transaminases or gamma GT \> 4N. * Peripheral neuropathy \> NCI grade 2. * Contraindication to high-dose corticosteroids, cyclophosphamide and anthracyclines. * Hypersensitivity to bortezomib or lenalidomide. * Pregnant woman or nursing mothers. * Malignant disease except for basal cell carcinoma or cervical carcinoma in situ. * Positive HIV serology; active hepatitis B or C. * Participation in a clinical trial during the 60 days prior to inclusion. * Patient not covered by French national health insurance.

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Conditions

The condition(s) this trial relates to.

plasma cell leukemia 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

    Paris, 75004, France

  • CH Dunkerque

    Dunkirk, 59385, France

  • CH Pays d'Aix

    Aix-en-Provence, 13616, France

  • CHRU Lille

    Lille, 59037, France

  • CHU Amiens

    Amiens, 80054, France

  • CHU Besançon

    Besançon, 25030, France

  • CHU Caen

    Caen, 14033, France

  • CHU Clermont Ferrand

    Clermont-Ferrand, 63003, France

  • CHU Dijon

    Dijon, 21034, France

  • CHU Nancy

    Nancy, 54035, France

  • CHU Nantes

    Nantes, 44093, France

  • CHU Nice

    Nice, 06003, France

  • CHU Poitiers

    Poitiers, 86021, France

  • CHU Rennes

    Rennes, 35033, France

  • CHU Strasbourg

    Strasbourg, 67091, France

  • CHU Toulouse

    Toulouse, 31059, France

  • CHU Tours

    Tours, 37044, France

  • Hospices Civils de Lyon

    Lyon, 69229, France

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