Treatment of Primary Plasma Cell Leukaemia in Subjects Under the Age of 70
LPP
1 other identifier
interventional
40
1 country
18
Brief Summary
Plasma cell leukaemia is a rare variety of multiple myeloma with a poor prognosis. Plasma cell leukaemia is defined as: at least 2,000 circulating plasma cells per µL for a blood leukocyte count higher than 10,000/µL or 20% of plasma cells for a leukocyte count less than 10,000/µL. Plasma cell leukaemia can be either primary, when it constitutes the first manifestation of the disease, or secondary in the setting of relapsed/refractory multiple myeloma. Primary plasma cell leukaemia (PPL) is a rare disease, representing only 1 to 2% of all cases of multiple myelomas at diagnosis. As the annual incidence of multiple myeloma in France is about 4,000 new cases, an estimated 40 to 80 new cases of PPL would be observed each year. Few data are currently available in the literature concerning the pathophysiology and therapeutic management of PPL, and are derived from retrospective series based small numbers of patients. The prognosis of PPL in response to conventional chemotherapy remains poor with a median survival of 7 to 14 months. However, longer survivals have been obtained with intensive therapy and haematopoietic stem cell transplantation (allogeneic or autologous HSCT). The investigators propose to perform a prospective study of the management of patients with PPL under the age of 70 years, in combination with a laboratory study: 12 weeks of induction chemotherapy by liposomal Bortezomib-Dexamethasone-Doxorubicin (PAD) alternating with Bortezomib-Dexamethasone-Cyclophosphamide (VCD) for a total of 4 cycles. Peripheral blood stem cell collection after mobilization by G-CSF will be performed after high-dose Cyclophosphamide chemotherapy. Autologous HSCT conditioned by high-dose Melphalan will be performed during the following month for all responding patients. During the 3 months after this first autologous HSCT, allogeneic HSCT with attenuated conditioning will be proposed in patients under the age of 66 years in complete remission with a suitable donor, and another systematic autologous HSCT will be proposed in all other patients. For all patients not treated by allogeneic HSCT, consolidation/maintenance therapy will be performed 3 months after the second autologous HSCT: 4 quarterly consolidations with Bortezomib-Lenalidomide-Dexamethasone (VRD) with maintenance by 2 months of Lenalidomide between these cycles, for a total duration of one year. The laboratory assessment will consist of blood and bone marrow samples systematically obtained at diagnosis for plasma cell phenotyping by cytometry, cytogenetics, FISH, study of the gene expression profile and SNParray. A DNA bank and plasma bank will be constituted. The investigators also propose to study residual disease by cytometry (after the first autologous HSCT, before and at the end of the consolidation/maintenance phase), as it increasingly appears to have a major impact on survival in multiple myeloma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 multiple-myeloma
Started Jan 2010
Typical duration for phase_2 multiple-myeloma
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 4, 2016
CompletedFirst Posted
Study publicly available on registry
August 8, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedSeptember 19, 2025
September 1, 2025
6.5 years
August 4, 2016
September 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease-free survival
3 years
Study Arms (1)
treatment
EXPERIMENTAL12 weeks of induction chemotherapy by liposomal Bortezomib-Dexamethasone-Doxorubicin (PAD) alternating with Bortezomib-Dexamethasone-Cyclophosphamide (VCD) for a total of 4 cycles PAD-VCD
Interventions
12 weeks of induction chemotherapy by liposomal Bortezomib-Dexamethasone-Doxorubicin (PAD) alternating with Bortezomib-Dexamethasone-Cyclophosphamide (VCD) for a total of 4 cycles
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
- Patient not covered by French national health insurance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
CH Pays d'Aix
Aix-en-Provence, 13616, 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
CH Dunkerque
Dunkirk, 59385, France
CHRU Lille
Lille, 59037, France
Hospices Civils de Lyon
Lyon, 69229, France
CHU Nancy
Nancy, 54035, France
CHU Nantes
Nantes, 44093, France
CHU Nice
Nice, 06003, France
AP-HP
Paris, 75004, 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
Related Publications (1)
Royer B, Minvielle S, Diouf M, Roussel M, Karlin L, Hulin C, Arnulf B, Macro M, Cailleres S, Brion A, Brechignac S, Belhadj K, Chretien ML, Wetterwald M, Chaleteix C, Tiab M, Leleu X, Frenzel L, Garderet L, Choquet S, Fuzibet JG, Dauriac C, Forneker LM, Benboubker L, Facon T, Moreau P, Avet-Loiseau H, Marolleau JP. Bortezomib, Doxorubicin, Cyclophosphamide, Dexamethasone Induction Followed by Stem Cell Transplantation for Primary Plasma Cell Leukemia: A Prospective Phase II Study of the Intergroupe Francophone du Myelome. J Clin Oncol. 2016 Jun 20;34(18):2125-32. doi: 10.1200/JCO.2015.63.1929. Epub 2016 Apr 25.
PMID: 27114594RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bruno ROYER, PhD
CHU Amiens
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2016
First Posted
August 8, 2016
Study Start
January 1, 2010
Primary Completion
July 1, 2016
Study Completion
September 1, 2016
Last Updated
September 19, 2025
Record last verified: 2025-09