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

NCT00107614 | Terminated Phase 2 Results DMC

• 1 other identifier: UARK 2002-10
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Waldenstrom Macroglobulinemia

Keywords

Waldenstrom

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years

Study Arms (1)

DT PACE/auto transplant/maint therapy

EXPERIMENTAL

Drug: DT PACE + Rituxan

Interventions

DT PACE + Rituxan DRUG

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

DT PACE/auto transplant/maint therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences/MIRT

Little Rock, Arkansas, 72205, United States

Location

Related Links

• Multiple Myeloma

MeSH Terms

Conditions

Waldenstrom Macroglobulinemia

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Early termination due to small numbers of subjects enrolled. Only one participant completed the study. Other participants came off study due to death, toxicity, physician choice, or patient choice.

Results Point of Contact

• Title: Nathan M. Petty
• Organization: University of Arkansas for Medical Sciences, Myeloma Institute

pettynathanm@uams.edu

501-526-6990

Study Officials

• Bart Barlogie, MD, PhD

  UAMS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2005
• First Posted: April 6, 2005
• Study Start: November 1, 2002
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: August 26, 2011
• Results First Posted: July 15, 2011

Record last verified: 2011-08

Locations

US (1)