Bortezomib and Rituximab for 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 and Rituximab for Patients With Waldenstrom's Macroglobulinemia

Official Title

Primary Treatment of Waldenstrom's Macroglobulinemia With Bortezomib (Velcade) and Rituximab (Rituxan) Followed by Autologous Stem Cell Collection

Brief Summary

      The main goal of this clinical research study is to learn if Velcade ® (bortezomib) given
      with rituximab can help to control WM. This drug combination will allow researchers to
      collect your stem cells in case it is possible to transplant the stem cells as treatment if
      your WM gets worse. Researchers will also look at the safety and tolerability of this drug
      combination followed by treatment with other drug combinations.
    

Detailed Description

      Bortezomib is designed to block a protein that plays a role in cell function and growth,
      which may cause cancer cells to die.

      Rituximab is designed to attach to cancer cells, which may cause them to die.

      Cyclophosphamide, vincristine, doxorubicin, and cladribine are designed to interfere with the
      multiplication of cancer cells, which may slow or stop their growth and spread throughout the
      body. This may cause the cancer cells to die.

      Dexamethasone is designed to decrease inflammation. It is also used to treat certain forms of
      cancer.

      Before you can start treatment on this study, you will have "screening tests." These tests
      will help the doctor decide if you are eligible to take part in this study. The tests may be
      performed within 28 days of starting the study drug. You will have a physical exam, including
      measurement of vital signs (blood pressure, heart rate, temperature, and breathing rate),
      height, and weight. Your medical history will be recorded. You will be asked to fill out a
      questionnaire regarding any neuropathy (nerve problems) you may have. The questionnaire will
      take about 1 minute to complete. You will have an electrocardiogram (ECG -- a test that
      measures the electrical activity of the heart). You will also have blood (about 4-5
      teaspoons) drawn one time and urine collected (over 24 hours) to check the status of your WM.
      This blood is also used to screen for hepatitis. You will have an x-ray of your chest. You
      will have computed tomography (CT) scans of your abdomen and pelvis to see which part of your
      body is involved with WM. If your chest x-ray is positive, you will also have a CT scan of
      your chest. Women who are able to have children must have a negative blood (about 2
      teaspoons) or urine pregnancy test before starting the study. You will also have a bone
      marrow aspiration and biopsy. To collect a bone marrow aspirate/biopsy, an area of the hip
      bone will be made numb with an anesthetic, and a small amount of bone marrow and bone will be
      withdrawn through a large needle.

      If you are found to be eligible to participate in this study, you will begin taking the study
      drugs. You will be given two 35-day cycles of bortezomib and rituximab. Bortezomib will be
      given through a needle in a vein over 3-5 seconds on Days 1, 8, 15, and 22. Rituximab will
      also be given through a vein on Days 8 and 22. The first rituximab infusion (by vein) usually
      takes 6-8 hours. Later infusions are generally shorter, taking about 4 hours to complete.
      While you are receiving bortezomib/rituximab (for 2-3 months), valacyclovir (an anti-viral
      drug) is taken by mouth, once a day.

      During the study, before each dose of bortezomib, you will have blood (about 2 teaspoons each
      time) drawn for routine tests. Your vital signs will be measured. You will be asked about any
      side effects you may have experienced. You will also be asked to answer the questionnaire
      about any neuropathy you may have.

      Stem cells are the cells from which all blood cells develop. If you respond to the first 2
      cycles of bortezomib/rituximab, you will then have some of your stems cells collected. You
      will have to sign a separate consent form that describes this procedure and its risks. After
      the stem cell collection, 1 cycle of cladribine, cyclophosphamide, and rituximab will be
      given. Cladribine will be given through a vein once a day over 2 hours on Days 1-5.
      Cyclophosphamide is taken by mouth, twice a day on Days 1-5, and rituximab is given through a
      vein once a week for 4 weeks.

      If you do not respond to the first cycle of bortezomib/rituximab, you will be taken off the
      study.

      If you respond to the first but do not respond to the second cycle of bortezomib/rituximab,
      you will receive a third cycle. The bortezomib/rituximab will be given in the same manner as
      your first 2 cycles.

      If you respond to the third cycle of bortezomib/rituximab, you will have some of your stems
      cells collected. After the stem cell collection, 1 cycle of cladribine, cyclophosphamide, and
      rituximab will be given. Cladribine will be given through a vein once a day over 2 hours on
      Days 1-5. Cyclophosphamide is taken by mouth, twice a day on Days 1-5, and rituximab is given
      through a vein once a week for 4 weeks.

      If you do not respond to the third cycle of bortezomib/rituximab, you will be given a
      chemotherapy regimen containing the drugs rituximab, cyclophosphamide, vincristine, and
      doxorubicin, together with dexamethasone. This combination is known as modified R-Hyper-CVAD.
      Rituximab will be given through a vein over about 4 hours on Day 1 only. Cyclophosphamide
      will be given through a vein every 12 hours on Days 1-4. Doxorubicin and vincristine will be
      given through a vein continuously over 24 hours on Days 1-4. Dexamethasone is taken by mouth
      daily on Days 1-4, 9-12, and 17-20.

      If a partial response is seen with modified R-Hyper-CVAD, you will have some of your stem
      cells collected. You will receive 1 cycle of cladribine, cyclophosphamide, and rituximab.
      Cladribine will be given through a vein once a day over 2 hours on Days 1-5. Cyclophosphamide
      is taken by mouth, twice a day on Days 1-5, and rituximab is given through a vein once a week
      for 4 weeks.

      About 1 week before the start of each cycle of chemotherapy, you will have blood (about 4-5
      teaspoons) drawn for routine tests and to see how your WM is responding. You may also need to
      collect your urine over 24 hours, depending on if the first test was initially positive or
      not. You will also have a complete physical exam, including measurement of vital signs,
      height, and weight.

      If your CT scans were positive initially, you will need to have them repeated after 2 cycles
      of bortezomib/rituximab and then every 6 months. Once you have a partial response confirmed
      by CT scans, you will not need to repeat the CT scans anymore.

      If your disease does not respond to modified R-Hyper-CVAD, you will be taken off the study.

      Responding participants will be followed at least every 6 months for the first 36 months
      (from the end of therapy). After that, you will be followed at least once a year unless the
      disease gets worse and needs to be re-treated. For the follow-up evaluations, you will have a
      physical exam, including measurement of vital signs. Blood (about 4 tablespoons) will be
      drawn for routine tests. Blood (about 4-5 teaspoons) and urine (over 24 hours) will be
      collected to check the status of your WM. If the x-rays and/or CT scans done at the beginning
      of the study were positive, you will have repeat x-rays and/or CT scans.

      For patients who have not had a partial response, follow-up evaluations will be at least
      every 3 months. You will have a physical exam, including measurement of vital signs. Blood
      (about 4 tablespoons) will be drawn for routine tests. Blood (about 4-5 tablespoons) and
      urine (over 24 hours) will be collected to check the status of your WM.

      You will be taken off the study if you do not have a partial or complete response following 3
      cycles of bortezomib/rituximab and 2 cycles of modified R-Hyper-CVAD. You will be taken off
      the study if the disease gets worse after all planned therapy that the study doctor feels
      requires repetition. You will be taken off the study if intolerable side effects occur. You
      will be taken off the study if treatment with bortezomib is delayed for more than 2 weeks.
      You will be taken off the study if you develop certain other illnesses, or if there are
      certain changes in your health that the study doctor decides may make further treatment with
      the study drugs to be unacceptable.

      Once you are taken off the study, you will have an end-of-study visit. At this visit, a
      physical exam, including measurement of vital signs, height, and weight will be performed.
      You will be asked about any side effects that you may have experienced. You will be asked to
      answer the questionnaire regarding any neuropathy you may have. Blood (about 4-6 teaspoons)
      will be drawn for routine tests and to check the status of your WM. You will need to collect
      your urine over 24 hours to see how your WM is responding. If your initial CT scans showed
      lesions that appear to be caused by WM, you will have a CT scan repeated at this time.

      If you have had a partial or complete response at the end of all planned therapy, you will
      need to return to the clinic for follow-up visits at least once every 6 months for the first
      36 months (from the end of therapy). After that, you will have follow-up visits at least once
      a year, unless the disease gets worse and re-treatment is necessary. At the follow-up visits,
      you will have a physical exam, including measurement of vital signs, height, and weight. You
      will be asked about any side effects that you may have experienced. Blood (about 4-6
      teaspoons) will be drawn for routine tests and to check the status of your WM. Depending on
      the results of your original urine tests, you may need to collect your urine over 24 hours to
      see how your WM is responding. If your initial CT scans showed lesions that appear to be
      caused by WM, you will have CT scans and an x-ray of your chest repeated at this time.

      This is an investigational study. Cyclophosphamide, vincristine, doxorubicin, and rituximab
      are commercially available and FDA-approved for treatment of Waldenstrom's macroglobulinemia.
      Bortezomib, dexamethasone, cladribine, and the drug combinations used in this study have been
      authorized for use in research only. Bortezomib has been FDA approved and it is registered in
      Europe for the treatment of multiple myeloma patients who have received at least one prior
      therapy. Tests/procedures that are required for this study are considered to be part of your
      routine medical care. Up to 38 patients will be enrolled in this study. All will be enrolled
      at MD Anderson.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Overall response rate to Bortezomib-Rituximab, and autologous stem cell collection rate after induction therapy with Bortezomib-Rituximab


Condition

Waldenstrom's Macroglobulinemia

Intervention

Bortezomib

Study Arms / Comparison Groups

 Bortezomib + Rituximab
Description:  Bortezomib 1.6 mg/m^2 IV Weekly on Days 1, 8, 15 and 22. Rituximab 375 mg/m^2 IV on Day 8 and 22. Valacyclovir 500 mg orally daily (or acyclovir 200 mg orally twice daily).

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

38

Start Date

August 2006

Completion Date

February 28, 2021

Primary Completion Date

February 28, 2021

Eligibility Criteria

        Inclusion Criteria:

          1. Patients with symptomatic macroglobulinemic lymphoma who have had no prior treatment,
             or whose prior treatment has been limited to steroids and/or alpha-interferon, are
             eligible. Macroglobulinemic lymphoma includes patients with either biopsy proven
             clonal lymphocytic or lymphoplasmacytic proliferation and monoclonal IgM. Also
             included are symptomatic patients with clonal proliferation producing a pathologic
             monoclonal IgM that causes cryoglobulinemia, peripheral neuropathy or cold agglutinin
             hemolytic anemia.

          2. Patients must have acceptable liver function (total bilirubin < 2.5mg/dL) and renal
             function (creatinine < 2.0mg/dL). Patients with impaired renal function will only be
             included if the renal failure is secondary to macroglobulinemic lymphoma (i.e. Bence
             Jones proteinuria, cryoglobulinemia, ureteral obstruction due to mass) that might
             reverse with improvement of disease.

          3. Female subject is either post-menopausal or surgically sterilized or willing to use an
             acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine
             device, diaphragm with spermicide, condom with spermicide, or abstinence) for the
             duration of the study.

          4. Male subject agrees to use an acceptable method for contraception for the duration of
             the study.

          5. Patients must voluntarily sign an informed consent form indicating that they are aware
             of the investigational nature of the study, with the understanding that consent may be
             withdrawn by the subject at any time without prejudice to future care.

          6. Patient has a heart rate (HR) of greater than or equal to 50 bpm.

        Exclusion Criteria:

          1. Patient has a platelet count of <30x10^9/L within 28 days before enrollment unless due
             to >/= 75% marrow infiltration by macroglobulinemic lymphoma or splenomegaly.

          2. Patient has an absolute neutrophil count of <1.0x10^9/L within 28 days before
             enrollment unless due to >/= 75% marrow infiltration by macroglobulinemic lymphoma.

          3. Patient has a calculated or measured creatinine >/= to 2.0mg/dL on baseline
             evaluation. Patients with impaired renal function will only be included if the renal
             failure is secondary to macroglobulinemic lymphoma (i.e. Bence Jones proteinuria,
             cryoglobulinemia, ureteral obstruction due to mass).

          4. Patient has >/= Grade 2 peripheral neuropathy on baseline evaluation.

          5. Myocardial infarction within 6 months prior to enrollment or has New York Heart
             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.

          6. Patient has hypersensitivity to boron, mannitol, or murine proteins.

          7. Female subject is pregnant or breast-feeding. Confirmation that the subject is not
             pregnant must be established by a negative serum or urine Beta -human chorionic
             gonadotropin (B-hCG) pregnancy test result obtained during screening. Pregnancy
             testing is not required for post-menopausal or surgically sterilized women.

          8. Patient has received other investigational drugs within 14 days before enrollment

          9. Patient has a serious medical or psychiatric illness that is likely to interfere with
             participation in this clinical study.

         10. Eastern Cooperative Oncology Group (ECOG) performance status of > 2.

         11. Patient with a "currently active" second malignancy, other than non-melanoma skin
             cancer and carcinoma in situ of the cervix, should not be enrolled. Patients are not
             considered to have a "currently active" malignancy if they have completed therapy for
             a prior malignancy, are disease free from prior malignancies for > 5 years and are
             considered by their physician to be at less than 30 % risk of relapse.

         12. Patient with a lifetime cumulative dose of > 450 mg/m^2 of anthracyclines.

         13. Patients with an active hepatitis B infection.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Sheeba Thomas, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00492050

Organization ID

2005-0733

Secondary IDs

NCI-2012-01498

Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center

Collaborators

 Millennium Pharmaceuticals, Inc.

Study Sponsor

Sheeba Thomas, MD, Principal Investigator, M.D. Anderson Cancer Center


Verification Date

April 2020