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DT PACE, Tandem Autologous Transplant, Maintenance Therapy for Waldenstrom's Macroglobulinemia Patients

Primary Purpose

Waldenstrom Macroglobulinemia

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DT PACE + Rituxan
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Waldenstrom Macroglobulinemia focused on measuring Waldenstrom

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients must have a pathological diagnosis of Waldenstrom's Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the following must be true: *Presence of cytopenias, defined as Hemoglobin < 11 gm%, or WBC < 2000/µl, or platelets < 100,000 µl; *Presence of extensive (>3 cm) or symptomatic lymphadenopathy or hepatosplenomegaly; *Presence of B symptoms (night sweats, fever, weight loss of >10% of the baseline); *Presence of severe neuropathy, not otherwise explained; *Progressive disease (increase in "M" by > 50% while observed, and decrease in hemoglobin by >2 gm%,and/or decrease in platelets by >50,000/µl, and/or increase in lymphadenopathy); *Serum albumin <2.5 gm%; *Persistently elevated β-2M >3.0 in the absence of renal impairment or active infection. Hyperviscosity will be treated (in addition to plasmapheresis) only in the presence of any of the above All necessary baseline studies for determining eligibility must be obtained within 35 days prior to registration. Patients must have a performance status of 0-2 based on SWOG criteria. Patients with a poor performance status (3-4), based solely on bone pain, will be eligible. Patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection. Patients with recent (< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrythmias are ineligible. Ejection fraction by ECHO must be > 50% and must be performed within 60 days prior to registration, unless the patient has received chemotherapy within that period of time (dexamethasone and thalidomide excluded), in which case the LVEF must be repeated. Patients must have a creatinine < 3 mg/dl and a creatinine clearance > 30 ml/minute. Patients with a creatinine clearance of 30-50 ml will only receive a 50% cisplatin dose. Patients must have adequate hepatic function defined as serum transaminases < 2 x ULN and direct bilirubin < 2.0 mg/dl. Patients must be able to receive full doses of DT PACE, in the opinion of the treating investigator, with the exception of: *Patients that have received prior adriamycin > 450 mg/m2 and LVEF < 55%. Adriamycin will be omitted in these patients; *Patients with a creatinine clearance 30 - 50 ml/minute, who will receive 50% of the cisplatin dose. Patients must not have a history of chronic obstructive or chronic restrictive pulmonary disease. Patients must have adequate pulmonary function studies > 50% of predicted on mechanical aspects (FEV1, FVC, etc) and diffusion capacity (DLCO) > 50% of predicted. Patients unable to complete pulmonary function tests due to myeloma related pain or fracture must have a high resolution CT scan of the chest and must also have acceptable arterial blood gases defined as PO2 greater than 70. Exclusion Criteria: No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least three years. Prior malignancy is acceptable provided there has been no evidence of disease within the three-year interval. Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy test documented within one week of registration. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.

Sites / Locations

  • University of Arkansas for Medical Sciences/MIRT

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DT PACE/auto transplant/maint therapy

Arm Description

Outcomes

Primary Outcome Measures

Response Rates to a Brief Remission Induction Treatment With One or Two Courses of Melphalan-based High-dose Treatment (HDT)
To evaluate the complete and partial response rates, defined in a strict manner, to a brief remission induction treatment with one or two courses of melphalan-based high-dose treatment (HDT) in symptomatic patients with Waldenström's Macroglobulinemia (WM), either untreated or previously treated.

Secondary Outcome Measures

Full Information

First Posted
April 5, 2005
Last Updated
August 24, 2011
Sponsor
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT00107614
Brief Title
DT PACE, Tandem Autologous Transplant, Maintenance Therapy for Waldenstrom's Macroglobulinemia Patients
Official Title
UARK 2002-10, A Phase II Study of DT PACE Induction, Followed by Tandem Autologous Transplant and Maintenance Therapy for Patients With Advanced and/or Symptomatic Waldenstrom's Macroglobulinemia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to poor accrual.
Study Start Date
November 2002 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to find out what the response is and the side effects are with chemotherapy using a combination of drugs called D.T. PACE (Dexamethasone, Thalidomide, cis-Platinum, Adriamycin, Cyclophosphamide, and Etoposide) + Rituxan, followed by two autologous transplants.
Detailed Description
Approximately 25 patients, male or female, age 18 and older, regardless of race or ethnicity, will participate in this study at UAMS (University of Arkansas for Medical Sciences) only. Participants will receive two courses of chemotherapy with a regimen called DT PACE + Rituxan. This regimen consists of 6 drugs: Dexamethasone, Thalidomide, cis-Platinum, Adriamycin, Cyclophosphamide, and Etoposide.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Waldenstrom Macroglobulinemia
Keywords
Waldenstrom

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DT PACE/auto transplant/maint therapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
DT PACE + Rituxan
Intervention Description
INDUCTION PHASE DT PACE + Rituxan DT PACE + Rituxan + PBSC Collection Response Assessment TRANSPLANT PHASE Transplant 1 (MEL 200 (patients with < 50% response to induction) OR MEL-DT PACE (Patients with > 50% response to Induction) Transplant 2 (identical to the first, except patients with progressive or proliferative disease, will receive BEAM) MAINTENANCE PHASE Rituxan every 3 months x 1 year
Primary Outcome Measure Information:
Title
Response Rates to a Brief Remission Induction Treatment With One or Two Courses of Melphalan-based High-dose Treatment (HDT)
Description
To evaluate the complete and partial response rates, defined in a strict manner, to a brief remission induction treatment with one or two courses of melphalan-based high-dose treatment (HDT) in symptomatic patients with Waldenström's Macroglobulinemia (WM), either untreated or previously treated.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have a pathological diagnosis of Waldenstrom's Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the following must be true: *Presence of cytopenias, defined as Hemoglobin < 11 gm%, or WBC < 2000/µl, or platelets < 100,000 µl; *Presence of extensive (>3 cm) or symptomatic lymphadenopathy or hepatosplenomegaly; *Presence of B symptoms (night sweats, fever, weight loss of >10% of the baseline); *Presence of severe neuropathy, not otherwise explained; *Progressive disease (increase in "M" by > 50% while observed, and decrease in hemoglobin by >2 gm%,and/or decrease in platelets by >50,000/µl, and/or increase in lymphadenopathy); *Serum albumin <2.5 gm%; *Persistently elevated β-2M >3.0 in the absence of renal impairment or active infection. Hyperviscosity will be treated (in addition to plasmapheresis) only in the presence of any of the above All necessary baseline studies for determining eligibility must be obtained within 35 days prior to registration. Patients must have a performance status of 0-2 based on SWOG criteria. Patients with a poor performance status (3-4), based solely on bone pain, will be eligible. Patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection. Patients with recent (< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrythmias are ineligible. Ejection fraction by ECHO must be > 50% and must be performed within 60 days prior to registration, unless the patient has received chemotherapy within that period of time (dexamethasone and thalidomide excluded), in which case the LVEF must be repeated. Patients must have a creatinine < 3 mg/dl and a creatinine clearance > 30 ml/minute. Patients with a creatinine clearance of 30-50 ml will only receive a 50% cisplatin dose. Patients must have adequate hepatic function defined as serum transaminases < 2 x ULN and direct bilirubin < 2.0 mg/dl. Patients must be able to receive full doses of DT PACE, in the opinion of the treating investigator, with the exception of: *Patients that have received prior adriamycin > 450 mg/m2 and LVEF < 55%. Adriamycin will be omitted in these patients; *Patients with a creatinine clearance 30 - 50 ml/minute, who will receive 50% of the cisplatin dose. Patients must not have a history of chronic obstructive or chronic restrictive pulmonary disease. Patients must have adequate pulmonary function studies > 50% of predicted on mechanical aspects (FEV1, FVC, etc) and diffusion capacity (DLCO) > 50% of predicted. Patients unable to complete pulmonary function tests due to myeloma related pain or fracture must have a high resolution CT scan of the chest and must also have acceptable arterial blood gases defined as PO2 greater than 70. Exclusion Criteria: No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least three years. Prior malignancy is acceptable provided there has been no evidence of disease within the three-year interval. Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy test documented within one week of registration. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bart Barlogie, MD, PhD
Organizational Affiliation
UAMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences/MIRT
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.myeloma.uams.edu
Description
Multiple Myeloma

Learn more about this trial

DT PACE, Tandem Autologous Transplant, Maintenance Therapy for Waldenstrom's Macroglobulinemia Patients

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