Efficacy of First Line DRC +/- Bortezomib for Patients With Waldenström’s Macroglobulinemia

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Macroglobulinemia and in IgM-MGUS Vaccine Therapy in Treating Patients With Lymphoplasmacytic Lymphoma Ofatumumab and Bortezomib in Treating Patients With Previously Untreated Waldenstrom Macroglobulinemia Perifosine in Patients With Relapsed/Refractory Waldenstrom’s Macroglobulinemia Randomised Trial in Waldenstrom’s Macroglobulinaemia A Study of Ibrutinib (PCI-32765) in Chinese Participants With Relapse or Refractory Waldenstrom’s Macroglobulinemia (WM) Pomalidomide, Dexamethasone and Rituximab in Waldenstrom’s Macroglobulinemia Study of the Combination of Bortezomib, Dexamethasone, and Rituximab in Patients With Waldenstroms Macroglobulinemia Study of Epratuzumab (hLL2) in Patients With Waldenstrom’s Macroglobulinemia A Study for Patients That Have Been Previously Been Treated in Waldenstrom’s Macroglobulinemia or Multiple Myeloma Ibrutinib With Rituximab in Adults With Waldenström’s Macroglobulinemia Oblimersen in Treating Patients With Relapsed or Refractory Waldenstrom’s Macroglobulinemia Investigating the Safety and Efficacy of Rituximab and Pembrolizumab in Relapsed/Refractory Waldenström’s Macroglobulinaemia An Open-label, Phase 2 Study of Acalabrutinib in Subjects With Waldenström Macroglobulinemia Simvastatin in Waldenstrom’s Macroglobulinemia Ibrutinib (PCI-32765) in Waldenstrom’s Macroglobulinemia Carfilzomib, Rituximab and Dexamethasone in Waldenstrom’s Macroglobulinemia Thalidomide and Rituximab in Waldenstrom’s Macroglobulinemia Comparison of ASCT and Conventional Chemotherapy in High Risk Waldenström Macroglobulinemia Fase II Study With BRB for Non-Hodgkin Lymphoplasmacytic Lymphoma/Waldenstrom Macroglobulinemia’s Study of Lenalidomide in Relapse/Refractory Waldenstrom Macroglobulinemia Efficacy of Bortezomib (Velcade(R)) in Patients With Advanced Waldenström Macroglobulinemia A Study of Daratumumab in Patients With Relapsed or Refractory Waldenström Macroglobulinemia A Study of Ulocuplumab And Ibrutinib in Symptomatic Patients With Mutated CXCR4 Waldenstrom’s Macroglobulinemia Study of Phosphatidylinositol-3-kinase (PI3K) Inhibitor Idelalisib (GS-1101) in Waldenström Macroglobulinemia Trial of Ixazomib, Dexamethasone and Rituximab in Patients With Untreated Waldenstrom’s Macroglobulinemia Study of Ibrutinib in Patients With Symptomatic, Previously Untreated Waldenstrom’s Macroglobulinemia, and Impact on Tumor Genomic Evolution Using Whole Genome Sequencing LBH589 in Relapsed or Relapsed and Refractory Waldenstrom’s Macroglobulinemia Everolimus, Bortezomib and/or Rituximab in Patients With Relapsed/Refractory Waldenstrom’s Macroglobulinemia A Phase II Trial of Ofatumumab in Subjects With Waldenstrom’s Macroglobulinemia Study of ABT-199 (GDC-199) In Patients With Relapsed Or Refractory Waldenström Macroglobulinemia Expression of Ku70/XRCC6 in Waldenström’s Macroglobulinemia Anti-Angiogenesis Therapy Using Thalidomide in Patients With Waldenstrom’s Macroglobulinemia Study of VTD in Waldenstrom’s Macroglobulinemia Dasatinib In Waldenström Macroglobulinemia The Comparison of RCD Versus BCD in Newly Diagnosed Waldenström Macroglobulinemia CC-5013 (Lenalidomide) and Rituximab in Waldenstrom’s Macroglobulinemia Combination Bortezomib and Rituximab in Patients With Waldenstrom’s Macroglobulinemia R-VRD Followed by Lenalidomide Maintenance in Patients With Waldenstrom’s Macroglobulinemia Phase 1/2 Dose Escalation Study in Patients With Relapsed or Refractory Waldenstrom’s Macroglobulinemia Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom’s Macroglobulinemia Efficacy of First Line B-RI for Treatment Naive Waldenström’s Macroglobulinemia Sildenafil Citrate in Waldenstrom’s Macroglobulinemia Bortezomib (Velcade) in Waldenstrom’s Macroglobulinemia Phase II Study of Campath-1H Antibody to Treat Waldenstrom’s Macroglobulinemia

Brief Title

Efficacy of First Line DRC +/- Bortezomib for Patients With Waldenström's Macroglobulinemia

Official Title

Efficacy of First Line Dexamethasone, Rituximab and Cyclophosphamide (DRC) +/- Bortezomib for Patients With Waldenström's Macroglobulinemia

Brief Summary

      In Waldenström macroglobulinemia (WM) conventional chemotherapy induces only low CR rates and
      responses of short duration compared to other indolent lymphomas. Thus innovative approaches
      are needed which combine excellent activity and tolerability in patients with WM, who are
      mostly of advanced age. The immunochemotherapy DRC (dexamethasone, rituximab,
      cyclophosphamide) was shown to be highly effective in patients with WM without inducing major
      hematological toxicities. On the other hand the proteasome inhibitor Bortezomib showed
      substantial activity as a single agent in WM with only very few side effects when given in a
      weekly schedule. Based on these observations it is the aim of this study to test whether the
      efficacy of the well tolerated DRC regime can be further improved by adding Bortezomib.
    

Detailed Description

      Waldenström's macroglobulinemia (WM) is defined by a bone marrow infiltration by
      lymphoplasmacytic cells and the presence of a monoclonal immunoglobulin (Ig) M gammopathy in
      the peripheral blood. The clinical understanding of the disease has been greatly improved by
      the identification of internationally recognized criteria for initiating therapy, the
      description of an international prognostic index for patients requiring a first-line therapy
      and the definition of response criteria. These criteria are mainly based on the evolution of
      serum IgM concentration. However, delayed IgM monoclonal protein responses may cause
      important difficulties in response assessment. In addition, discrepancies between the
      kinetics of serum M protein reduction and the clearance of monoclonal B-cells from the bone
      marrow have been reported. Despite continuing advances in the therapy of WM, the disease
      remains incurable with a median survival of 5 to 8 years from the time of diagnosis thereby
      necessitating the development and evaluation of novel treatment approaches.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Progression Free Survival

Secondary Outcome

 Response rate

Condition

Waldenström's Macroglobulinemia

Intervention

Dexamethasone, Rituximab, Cyclophosphamide

Study Arms / Comparison Groups

 DRC+Bortezomib
Description:  Induction experimental arm (Arm B):
Cycle 1:
Bortezomib 1.6 mg/m2 s.c. Day 1,8,15; Dexamethasone 20 mg p.o. Day 1; Rituximab 375 mg/m2 i.v. Day 1; Cyclophosphamide 100 mg/m2 x 2 p.o. Day 1-5
Cycle 2-6:
Bortezomib 1.6 mg/m2 s.c. Day 1,8,15; Dexamethasone 20 mg p.o. Day 1; Rituximab 1400 mg absolute sc Day 1; Cyclophosphamide 100 mg/m2 x 2 p.o. Day 1-5; Repeat day 29.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

202

Start Date

November 2013

Completion Date

April 2024

Primary Completion Date

November 2018

Eligibility Criteria

        Inclusion Criteria:

        Clinicopathological diagnosis of WM as defined by consensus panel one of the Second
        International Workshop on WM. Pathological diagnosis has to occur before study inclusion
        and randomization. In addition, pathological specimens have to be sent to the national
        pathological reference center at study inclusion and randomization. The positivity for CD20
        can be assumed from any previous bone marrow immunohistochemistry or flow cytometry
        analysis performed up to 6 months prior to enrollment. Inclusion in the study will be based
        on morphological and immunological criteria. Immunophenotyping will be performed in each
        center and saved locally. Flow cytometry of bone marrow and blood cells will include at
        least one double staining and assess the expression of the following antigens: surface
        immunoglobulin, CD19, CD20, CD5, CD10 and CD23. Patients are eligible if tumor cells
        express the following antigens: CD19, CD20, and if they are negative for CD5, CD10 and CD23
        expression. Patients with tumor cells positive for CD5 and/or CD23 and morphologically
        similar to WM cells may be included after ruling out other low grade B-cell malignancies.

          -  Presence of at least one criterion for initiation of therapy, according to the 2nd
             Workshop on WM:

               -  Recurrent fever, night sweats, weight loss, fatigue

               -  Hyperviscosity

               -  Lymphadenopathy which is either symptomatic or bulky (≥5 cm in maximum diameter)

               -  Symptomatic hepatomegaly and/or splenomegaly

               -  Symptomatic organomegaly and/or organ or tissue infiltration

               -  Peripheral neuropathy due to WM

               -  Symptomatic cryoglobulinemia

               -  Cold agglutinin anemia

               -  IgM related immune hemolytic anemia and/or thrombocytopenia

               -  Nephropathy related to WM

               -  Amyloidosis related to WM

               -  Hemoglobin ≤10g/dL

               -  Platelet count <100x10^9/L

               -  Serum monoclonal protein >5g/dL, even with no overt clinical symptoms Cumulative
                  illness rating scale (CIRS) score less than 6

          -  World Health Organization (WHO)/ECOG performance status 0 to 2.

          -  Other criteria:

               -  Age ≥ than 18 years

               -  Life expectancy >3 months.

               -  Baseline platelet count ≥ 50 ×10^9/L, absolute neutrophil count ≥ 0.75×10^9/L (if
                  not due to BM infiltration by the lymphoma).

               -  Meet the following pretreatment laboratory criteria at the Screening visit
                  conducted within 28 days of study enrollment:

                    -  ASAT (SGOT): ≤3 times the upper limit of institutional laboratory normal
                       value

                    -  ALAT (SGPT): ≤3 times the upper limit of institutional laboratory normal
                       value

                    -  Total Bilirubin: ≤20 mg/L or 2 times the upper limit of institutional
                       laboratory normal value, unless clearly related to the disease (except if
                       due to Gilbert's syndrome)

                    -  Serum creatinine: ≤ 2mg/dl

          -  Premenopausal fertile females must agree to use a highly effective method of birth
             control for the duration of the therapy up to 6 months after end of therapy. A highly
             effective method of birth control is defined as those which result in a low failure
             rate (i.e. less than 1% per year) when used consistently and correctly such as
             implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or
             vasectomised partner.

          -  Men must agree not to father a child for the duration of therapy and 6 months after
             and must agree to advice a female partner to use a highly effective method of birth
             control.

          -  Voluntary written informed consent before performance of any study-related procedure
             not part of normal medical care, with the understanding that consent may be withdrawn
             by the subject at any time without prejudice to future medical care.

        Exclusion criteria:

          -  Prior systemic treatment of the WM (plasmapheresis and short- term administration of
             corticosteroids < 4 weeks administered at a dose equivalent to < 20 mg/day prednisone
             is allowed)

          -  Patient with hypersensitivity to dexamethasone.

          -  Serious medical or psychiatric illness likely to interfere with participation in this
             clinical study.

          -  Uncontrolled bacterial, viral or fungal infection

          -  Active HIV, HBV or HCV infection

          -  Known interstitial lung disease

          -  Prior allergic reaction or severe anaphylactic reaction related to humanized or murine
             monoclonal antibody.

          -  Central Nervous System involvement by lymphoma

          -  Prior history of malignancies unless the subject has been free of the disease for ≥ 5
             years. Exceptions include the following:

               -  Basal cell carcinoma of the skin,

               -  Squamous cell carcinoma of the skin,

               -  Carcinoma in situ of the cervix,

               -  Carcinoma in situ of the breast,

               -  Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b).

          -  Uncontrolled illness including, but not limited to:

               -  Uncontrolled diabetes mellitus mellitus (as indicated by metabolic derangements
                  and/or severe diabetes mellitus related uncontrolled organ complications)

               -  Chronic symptomatic congestive heart failure (Class NYHA III or IV).

               -  Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within
                  6 months

               -  Clinically significant cardiac arrhythmia that is symptomatic or requires
                  treatment, or asymptomatic sustained ventricular tachycardia.

               -  Known pericardial disease

          -  Subjects with ≥ Grade 2 neuropathy.

          -  Women who are pregnant as well as women who are breastfeeding and do not consent to
             discontinue breast-feeding.

          -  Participation in another clinical trial within four weeks before randomization in this
             study

          -  No consent for registration, storage and processing of the individual
             disease-characteristics and course as well as information of the family physician
             about study participation.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Martin Dreyling, MD, , 

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT01788020

Organization ID

ECWM-1

Secondary IDs

2013-000506-37

Responsible Party

Principal Investigator

Study Sponsor

University of Ulm

Collaborators

 Centre Hospitalier de Lens, Unité de Recherche Clinique, Lens (Co-Sponsor)

Study Sponsor

Martin Dreyling, MD, Principal Investigator, National Co-Coordinating Investigator - Germany University Hospital Großhadern, Munich


Verification Date

May 2021