Bortezomib, Dexamethasone, and Rituximab in Previously Untreated Patients With Waldenstrom’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

Bortezomib, Dexamethasone, and Rituximab in Previously Untreated Patients With Waldenstrom's Macroglobulinemia

Official Title

Phase II Study of Combination Bortezomib, Dexamethasone, and Rituximab in Previously Untreated Patients With Waldenstrom's Macroglobulinemia: A Multicenter Trial of the European Myeloma Network

Brief Summary

      Rituximab is a monoclonal antibody with proven efficacy in WM but responses are slow.
      Bortezomib has shown significant and rapid activity in WM. Combinations of bortezomib with
      rituximab nad dexamethasone with rituximab have shown synergistic activity in laboratory
      studies and clinical trials. This is a Phase II multicenter study designed to evaluate the
      safety and efficacy of the combination of Bortezomib , Rituximab and dexamethasone (BDR). BDR
      will be administered in one 21-day treatment cycle followed by four 35-day treatment cycles
      to patients with WM. Bortezomib will be administered as an iv push over 3 to 5 seconds at a
      dose of 1.3mg/m2/day on days 1,4,8 and 11 of cycle 1. On cycles 2-5 bortezomib will be given
      at a dose of 1.6mg/m2/day on days 1,8,15 and 22 of each cycle. Only on cycles 2 and 5,
      following the administration of Bortezomib, dexamethasone 40mg iv and Rituximab 375 mg/m2 iv
      will be administered. A total of 8 infusions of rituximab will be administered. Subsequently
      patients rated as CR, PR, MR or SD will be followed without any treatment until there is
      evidence of progressive disease.
    

Detailed Description

      Waldenstrom's macroglobulinemia (WM) is a distinct B-cell lymphoproliferative disorder
      characterized primarily by bone marrow infiltration with lymphoplasmacytic cells, along with
      demonstration of an IgM monoclonal gammopathy. This condition is considered to correspond to
      the lymphoplasmacytoid lymphoma as defined by the REAL2 and WHO classification systems. WM is
      a rare disease, with an incidence that is less frequent than multiple myeloma, and accounts
      for approximately 2% of all hematologic malignancies. The age-adjusted incidence rate is 3.4
      per million among males and 1.7 per million among females in the US, with a geometrical
      increase with age. 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 therapeutics. Overall response rates
      (ORR) of 30-70% with complete response (CR) rates of up to 10% have been reported with the
      use of alkylator agents (e.g. chlorambucil), nucleoside analogues (cladribine or
      fludarabine), and the monoclonal antibody rituximab these therapeutic agents in the upfront
      therapy of WM with median durations of response averaging 2-3 years. Higher response rates
      including CR rates of up to 20% have been reported in studies combining nucleoside analogues
      with rituximab, and/or alkylator agents. Importantly, individual patients including the
      presence of cytopenias, need for more rapid disease control, age, and in particular candidacy
      for autologous transplant therapy should be taken into account in making the choice of first
      line therapy. For patients who are candidates for autologous transplant therapy, and in whom
      such therapy is seriously considered, exposure to alkylator or nucleoside analogue therapy
      should be limited. Monoclonal antibodies have been successfully used to treat patients with
      Waldenstrom's macroglobulinemia (WM). Most of these efforts to date have focused on the use
      of rituximab, a chimeric IgG1 monoclonal antibody which targets CD20, an antigen which is
      widely expressed in WM. Several studies employing standard dose rituximab therapy have
      demonstrated major response (>50% reduction in serum IgM) rates of 30%, and durations of
      response of about 8 months13-17. More recently, the use of extended schedule rituximab has
      been evaluated. Time to response after rituximab is slow and exceeds 3 months on the average.
      In many patients a transient increase of serum IgM may occur immediately following initiation
      of rituximab. Such an increase does not herald treatment failure and most patients will
      return to their baseline serum IgM by 12 weeks. However, patients with baseline serum IgM
      levels of >50g/L may be particularly at risk for a hyperviscosity-related event. Bortezomib
      is a small molecule proteasome inhibitor developed by Millennium Pharmaceuticals, Inc., (MPI)
      as a novel agent to treat human malignancies. Bortezomib is currently approved by the US FDA
      and by the European EMEA for the treatment of multiple myeloma. By inhibiting a single
      molecular target, the proteasome, bortezomib affects multiple signaling pathways. The
      anti-neoplastic effect of bortezomib likely involves several distinct mechanisms, including
      inhibition of cell growth and survival pathways, induction of apoptosis, and inhibition of
      expression of genes that control cellular adhesion, migration and angiogenesis. Thus, the
      mechanisms by which bortezomib elicits its anti-tumor activity may vary among tumor types,
      and the extent to which each affected pathway is critical to the inhibition of tumor growth
      could also differ. The mechanism of anti-tumor activity in NHL is not known; however,
      bortezomib inhibits the growth of various human lymphoma cell lines, as well as the survival
      primary WM cells. Bortezomib has been administered to patients with WM in the context of
      prospective studies. Chen et al administered bortezomib to 16 patients with either untreated
      or pretreated WM who had received ≤3 prior regimens. Six of 13 evaluable patients (46%)
      achieved a partial response. Dimopoulos et al administered bortezomib to 10 patients with
      relapsed or refractory WM. Six of these patients achieved a partial response which occurred
      at a median of 1 month. The median time to progression in the responding patients is expected
      to exceed 11months. The more common toxicities were mild or moderate thrombocytopenia, fever
      and fatigue; peripheral neuropathy occurred in 3 patients. The WM Clinical Trials Group
      (WMCTG) conducted a Phase II Study (DFCI Protocol 03-248) of single-agent bortezomib in 27
      patients with relapsed or refractory WM. In an interim analysis, the safety and efficacy
      results for 15 patients who completed at least 2 cycles of therapy were reported.37 Eight and
      7 of these patients had relapsed and refractory disease, respectively. With a median of 3
      completed cycles (range 2-8), 12 of 15 (80%) patients have demonstrated a response with 5
      partial responses (>50% decrease in serum IgM) and 7 minor responses (>25% decrease in serum
      IgM) observed. Three other patients remain with stable disease. Therapy was generally well
      tolerated with greater than grade II adverse events as follows: neuropathy (n=3; 20%);
      neutropenia (n=3; 20%); thrombocytopenia (n=1; 7%); and rash (n=1; 7%). Adverse events were
      generally reversible and returned to baseline after holding or dose modifying the study drug.

      Bortezomib (velcade) in combination with Rituximab have been shown to act synergistically in
      in vitro and in vivo models. Bortezomib plus Rituximab in combination have been used in a
      phase 2 clinical study for previously treated patients with indolent non-Hodgkin's lymphoma.
      Patients received either Bortezomib 1,3mg/m2 on d1,4,8,11 q21 days (Group A), or Bortezomib
      1,6mg/m2 weekly on d1,8,15,22 q35 days (Group B). Rituximab 375mg/m2 was administered weekly
      for 4 weeks in all patients. Response rated were similar in groups A and B, but patients in
      Group B (weekly bortezomib at increased dose) experienced less toxicity. Furthermore,
      glucocorticoids acte synergistically with Rituximab in inducing apoptosis against various
      malignant NHL B cell lines. A single dose of dexamethasone administered immediately before
      rituximab was adequate for this synergistic effect. Furthermore, we have tested this sequence
      in vivo in the context of a prospective trial of dexamethasone, rituximab and
      cyclophosphamide for previously untreated patients with WM. This combination induced
      responses in 74% of patients. Based on the above we investigate a combination of bortezomib,
      dexamethasone and rituximab (BDR) as primary treatment for patients with WM. The following
      points are of importance:

      A) Only patients who have an indication for treatment will be included and will exclude
      asymptomatic patients. This is one of few multicenter trials designed specifically for WM
      patients who have a predefined indication for treatment.

      B) By avoiding any stem cell toxic agent, we believe that we will be able to collect adequate
      number of blood stem cells from our patients≤70 years of age. These stem cells could be used
      to support high dose therapy at the time of relapse after BDR.

      C) Our previous experience with single agent bortezomib indicates a median time to response
      of one month. Thus, by starting treatment with bortezomib alone, we believe that we will
      abrogate the "IgM flare" phenomenon that occurs in almost 50% of patients receiving
      single-agent rituximab.

      D) We will limit the use of dexamethasone to one dose (40mg) just before the administration
      of rituximab based on in vitro data. In contrast to multiple myeloma, there is no evidence
      that dexamethasone is essential for the treatment of WM. Furthermore repetitive
      administration of dexamethasone may be associated with increased risk for opportunistic
      infections.

      E) We plan to administer no more than 5 cycles of bortezomib in order to avoid the increased
      incidence of neuropathy which usually occurs with more exposure to bortezomib. Subsequently
      the patients will be followed with no treatment until there is evidence of progressive
      disease.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

To determine the response rate [the combined complete response (CR) + partial response (PR) + minimal response (MR)] following treatment with BDR in patients with previously untreated WM.

Secondary Outcome

 determine time to progression and assess the safety and tolerability of BDR in patients with WM.

Condition

Waldenstrom's Macroglobulinemia

Intervention

Bortezomib, Rituximab, Dexamethasone

Study Arms / Comparison Groups

 Bortezomib, Rituximab, Dexamethasone
Description:  BDR will be administered in one 21-day treatment cycle followed by four 35-day treatment cycles to patients with WM. Bortezomib will be administered as an iv push over 3 to 5 seconds at a dose of 1.3mg/m2/day on days 1,4,8 and 11 of cycle 1. On cycles 2-5 bortezomib will be given at a dose of 1.6mg/m2/day on days 1,8,15 and 22 of each cycle. Only on cycles 2 and 5, following the administration of Bortezomib, dexamethasone 40mg iv and Rituximab 375 mg/m2 iv will be administered. A total of 8 infusions of rituximab will be administered. Subsequently patients rated as CR, PR, MR or SD will be followed without any treatment until there is evidence of progressive disease.

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

59

Start Date

March 2007

Completion Date

November 2015

Primary Completion Date

November 2010

Eligibility Criteria

        Inclusion Criteria:

          -  Clinicopathological diagnosis of Waldenstrom's macroglobulinemia as defined by
             consensus panel one of the Second International Workshop on Waldenstrom's
             macroglobulinemia.1 All patients with the diagnosis of WM will be evaluable for
             response according to the response criteria (section 8.1)

          -  No prior systemic treatment for WM. Prior plasmapheresis to control hyperviscosity, is
             allowed. In that case baseline monoclonal protein levels for assessment of response
             will be the levels prior to plasmapheresis, if this is the higher value prior to
             treatment initiation

          -  Patients must have at least one of the following indications to initiate treatment as
             defined by "Consensus Panel Two" recommendations from the Second International
             Workshop on Waldenstrom's Macroglobulinemia41.

               1. Recurrent fever, night sweats, weight loss, fatigue

               2. Hyperviscosity

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

               4. Symptomatic hepatomegaly and/or splenomegaly

               5. Symptomatic organomegaly and/or organ or tissue infiltration

               6. Peripheral neuropathy due to WM

               7. Symptomatic cryoglobulinemia

               8. Cold agglutinin anemia

               9. Immune hemolytic anemia and/or thrombocytopenia

              10. Nephropathy related to WM

              11. Amyloidosis related to WM

              12. Hemoglobin ≤10g/dL

              13. Platelet count <100x109/L

              14. Serum monoclonal protein >5g/dL even with no symptoms

          -  CD20 positive disease based on any previous bone marrow immunohistochemistry or flow
             cytometric analysis performed up to 3 months prior to enrollment.

          -  Karnofsky performance status >=60.

          -  Life-expectancy >3 months.

          -  Baseline platelet count >=50 10^9/L, and absolute neutrophil count >= 0.75 10^9/L.

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

          -  AST (SGOT): >3 times the upper limit of institutional laboratory normal.

          -  ALT (SGPT): >3 times the upper limit of institutional laboratory normal.

          -  Total Bilirubin: >2 times the upper limit of institutional laboratory normal, unless
             clearly related to the disease.

          -  Calculated or measured creatinine clearance: >=30 mL/minute.

          -  Serum sodium >130 mmol/L.

          -  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 with WM (plasmapheresis is allowed)

          -  Myocardial infarction within 6 months prior to enrollment or has New York Hospital
             Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe
             uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute
             ischemia or active conduction system abnormalities. Prior to study entry, any ECG
             abnormality at Screening has to be documented by the investigator as not medically
             relevant.

          -  Patient has hypersensitivity to dexamethasone, bortezomib, boron or mannitol.

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

          -  Cardiac amyloidosis

          -  Peripheral neuropathy or neuropathic pain grade 2 or higher as defined by NCI CTCAE
             version 3

          -  Women who are pregnant. Women who are breast-feeding and do not consent to discontinue
             breast-feeding. Women of childbearing age who are not willing to use effective
             anti-conceptive methods for the duration of the study and 6 months thereafter. Men who
             do not consent not to father a child during the treatment period and six months
             thereafter.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Meletios A Dimopoulos, MD, , 

Location Countries

Greece

Location Countries

Greece

Administrative Informations


NCT ID

NCT01046006

Organization ID

26866138-CAN-2021


Responsible Party

Sponsor-Investigator

Study Sponsor

Meletios A. Dimopoulos

Collaborators

 European Myeloma Network

Study Sponsor

Meletios A Dimopoulos, MD, Principal Investigator, University of Athens, School of Medicine


Verification Date

April 2021