Bortezomib and Rituximab for Patients With Waldenstrom's Macroglobulinemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00492050
First received: June 26, 2007
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Waldenstrom's Macroglobulinemia
Drug: Bortezomib
Drug: Rituximab
Drug: Valacyclovir
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Primary Treatment of Waldenstrom's Macroglobulinemia With Bortezomib (Velcade) and Rituximab (Rituxan) Followed by Autologous Stem Cell Collection

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Overall response rate to Bortezomib-Rituximab, and autologous stem cell collection rate after induction therapy with Bortezomib-Rituximab [ Time Frame: Within 1 week prior to the start of each cycle of chemotherapy and every 3 months thereafter until Partial Recovery (PR) achieved ] [ Designated as safety issue: No ]

Estimated Enrollment: 38
Study Start Date: August 2006
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bortezomib + Rituximab
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).
Drug: Bortezomib
1.6 mg/m^2 IV Weekly on Days 1, 8, 15 and 22.
Other Names:
  • Velcade
  • LDP-341
  • MLN341
  • PS-341
Drug: Rituximab
375 mg/m^2 IV on Day 8 and 22.
Other Name: Rituxan
Drug: Valacyclovir
500 mg orally daily (or acyclovir 200 mg orally twice daily)
Other Name: Valtrex

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492050

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Millennium Pharmaceuticals, Inc.
Investigators
Principal Investigator: Sheeba Thomas, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00492050     History of Changes
Other Study ID Numbers: 2005-0733
Study First Received: June 26, 2007
Last Updated: December 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Waldenstrom's Macroglobulinemia
Macroglobulinemic Lymphoma
Stem Cell Collection
Bortezomib
LDP-341
MLN341
PS-341
Velcade
Rituximab
Rituxan

Additional relevant MeSH terms:
Waldenstrom Macroglobulinemia
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Plasma Cell
Paraproteinemias
Vascular Diseases
Bortezomib
Rituximab
Valacyclovir
Anti-Infective Agents
Antineoplastic Agents
Antirheumatic Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014