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Trial record 5 of 31 for:    "Plasma Cell Leukemia"

Treatment of Primary Plasma Cell Leukaemia in Subjects Under the Age of 70 (LPP)

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ClinicalTrials.gov Identifier: NCT02858999
Recruitment Status : Completed
First Posted : August 8, 2016
Last Update Posted : December 1, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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.


Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: PAD-VCD Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Primary Plasma Cell Leukaemia in Subjects Under the Age of 70: Phase II Multicentre Study
Study Start Date : January 2010
Actual Primary Completion Date : July 2016
Actual Study Completion Date : September 2016


Arm Intervention/treatment
Experimental: treatment
12 weeks of induction chemotherapy by liposomal Bortezomib-Dexamethasone-Doxorubicin (PAD) alternating with Bortezomib-Dexamethasone-Cyclophosphamide (VCD) for a total of 4 cycles PAD-VCD
Drug: PAD-VCD
12 weeks of induction chemotherapy by liposomal Bortezomib-Dexamethasone-Doxorubicin (PAD) alternating with Bortezomib-Dexamethasone-Cyclophosphamide (VCD) for a total of 4 cycles




Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02858999


Locations
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France
CH Pays d'Aix
Aix-en-Provence, France, 13616
CHU Amiens
Amiens, France, 80054
CHU Besançon
Besançon, France, 25030
CHU Caen
Caen, France, 14033
CHU Clermont Ferrand
Clermont Ferrand, France, 63003
CHU Dijon
Dijon, France, 21034
CH Dunkerque
Dunkerque, France, 59385
CHRU Lille
Lille, France, 59037
Hospices Civils de Lyon
Lyon, France, 69229
CHU Nancy
Nancy, France, 54035
CHU Nantes
Nantes, France, 44093
CHU Nice
Nice, France, 06003
AP-HP
Paris, France, 75004
CHU Poitiers
Poitiers, France, 86021
CHU Rennes
Rennes, France, 35033
CHU Strasbourg
Strasbourg, France, 67091
CHU Toulouse
Toulouse, France, 31059
CHU Tours
Tours, France, 37044
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Bruno ROYER, PhD CHU Amiens

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02858999     History of Changes
Other Study ID Numbers: AOL09-DR-ROYER
First Posted: August 8, 2016    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: November 2016

Keywords provided by Centre Hospitalier Universitaire, Amiens:
primary plasma cell leukaemia
treatment

Additional relevant MeSH terms:
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Leukemia, Plasma Cell
Leukemia
Multiple Myeloma
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases