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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

Phase 2
18 Years
Not Enrolling
Waldenstrom Macroglobulinemia

Thank you

Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rates to a Brief Remission Induction Treatment With One or Two Courses of Melphalan-based High-dose Treatment (HDT)

Outcome 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.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Bart Barlogie, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:



United States: Institutional Review Board

Study ID:

UARK 2002-10



Start Date:

November 2002

Completion Date:

February 2008

Related Keywords:

  • Waldenström Macroglobulinemia
  • Waldenstrom
  • Waldenstrom Macroglobulinemia



University of Arkansas for Medical Sciences/MIRT Little Rock, Arkansas  72205