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DTPACE Followed by Tandem Transplant With Melphalan (MEL) 200 Versus MEL/Dexamethasone/Thalidomide (DT) Platinol/Adriamycin/Etoposide (PACE) Hybrid and DTPACE Consolidation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00083915
First Posted: June 4, 2004
Last Update Posted: November 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Arkansas
  Purpose
The purpose of this study is to find out if transplant with a new regimen of chemotherapy called DT PACE-Melphalan is better than transplant with Melphalan alone. DT-PACE refers to a chemotherapy regimen for multiple myeloma consisting of Dexamethasone, Thalidomide, Cisplatin or Platinol, Adriamycin or doxorubicin, Cyclophosphamide, and Etoposide. Another purpose of this study is to find out if there will be fewer side effects with the new regimen of DT PACE-Melphalan, compared to melphalan alone.

Condition Intervention Phase
Multiple Myeloma Drug: Cisplatin Drug: Cyclophosphamide Drug: Adriamycin Drug: Etoposide Drug: Melphalan Drug: Thalidomide Drug: Dexamethasone Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: University of Arkansas (UARK 2001-12), A Phase III Study of DTPACE Followed by Tandem Transplant With MEL 200 Versus MEL/DTPACE Hybrid and DTPACE Consolidation in Patients With Active Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Transplant With DT PACE-Melphalan Regimen of Chemotherapy vs. Transplant With Melphalan Alone. [ Time Frame: 3 years depending on start date ]
    Compare a new regimen of chemotherapy called DT PACE-Melphalan (new experimental therapy) is better than transplant with Melphalan alone (standard therapy)


Enrollment: 97
Study Start Date: June 2001
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Auto Transplant w/ High Dose Melphalan
Autologous transplant with High Dose Melphalan alone
Drug: Melphalan
200 mg/m2 IV over <20 minutes on -1 on Arm 1. 50mg/m2 IV over 20 minutes days -3 and -2 on Arm 2.
Other Name: alkeran
Active Comparator: Auto Transplant w/ Melphalan + DT Pace
Melphalan plus Dexamethasone, Thalidomide, CisPlatinum, Adriamycin, Cyclophosphamide, and Etoposide
Drug: Cisplatin
20mg/m2 continuous infusion days -3 and -2.
Other Names:
  • Cisplatinum
  • cis-diamminedichloroplatinum
  • Platinol
  • Platinol-injectable (AQ)
Drug: Cyclophosphamide
800 mg/m2 continuous infusion days -3 and -2.
Other Names:
  • Endoxan
  • Cytoxan
  • Neosar
  • Procytox
  • Revimmune
Drug: Adriamycin
20mg/m2 continuous infusion -3 and -2.
Other Names:
  • hydroxydaunorubicin
  • Doxorubicin
Drug: Etoposide
80mg/m2 continuous infusion -3 and -2.
Other Names:
  • Eposin
  • Etopophos
  • Vepesid
Drug: Melphalan
200 mg/m2 IV over <20 minutes on -1 on Arm 1. 50mg/m2 IV over 20 minutes days -3 and -2 on Arm 2.
Other Name: alkeran
Drug: Thalidomide
200mg PO Continuing to Day +5, then hold until platelets >50 thousand (K).
Other Name: Thalomid
Drug: Dexamethasone
40 mg po days 1 - 4 (4 days)
Other Name: Decadron

Detailed Description:
To evaluate, in a randomized phase III clinical trial in previously treated multiple myeloma patients, whether angio-chemotherapy with D.T. PACE followed by tandem transplant with MEL-DTPACE Hybrid may be equivalent or superior to tandem transplant with high dose melphalan in terms of complete remission (CR)/near CR/very good partial remission (VGPR) rate and event-free and overall survival.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have active multiple myeloma requiring treatment.
  • Patients that have received >450 mg/m2 of prior Adriamycin therapy are eligible, however, Adriamycin will be deleted from the DT PACE regimen in these patients, unless the left ventricular ejection fraction is > 55% on Multi-gated Acquisition Scan (MUGA) or Echocardiogram (ECHO). If the patient has had > 450 mg/m2 of prior adriamycin, the LVEF must be evaluated prior to every cycle of DT PACE and it must be > 55% for patient to continue to receive adriamycin.
  • 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 Southwest Oncology Group (SWOG) criteria. Patients with a poor performance status (3-4), based solely on bone pain, will be eligible.
  • Patients must have a platelet count greater than or equal to 100,000/microliters. Patients with platelet count <100,000/microliters may be enrolled if it is felt to be due to extensive marrow plasmacytosis.
  • Patients must have a creatinine <3 mg/dl and a creatinine clearance greater than or equal to 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 Upper limit of normal (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 some exception of: Patients that have received prior adriamycin > 450 mg/m2 and left ventricular ejection fraction (LVEF) < 55% or patients with a creatinine clearance 30 - 50 ml/minute, who will receive 50% of the cisplatin dose.
  • 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.

Exclusion Criteria:

  • Patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection.
  • Patients must not have received a prior autotransplant or allograft.
  • Patients with recent (less than or equal to 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 or must be greater than or equal to 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 not have a history of chronic obstructive or chronic restrictive pulmonary disease.
  • 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.
  • Patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection.
  • Patients must not have a history of chronic obstructive or chronic restrictive pulmonary disease. Patients must have adequate pulmonary function studies greater than or equal to 50% of predicted on mechanical aspects (FEV1, forced vital capacity (FVC) and diffusion capacity (DLCO) greater than or equal to 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 P02 greater than 70.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00083915


Locations
United States, Arkansas
University of Arkansas for Medical Sciences/MIRT
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Frits van Rhee, M.D., Ph.D. UAMS
  More Information

Additional Information:
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00083915     History of Changes
Other Study ID Numbers: UARK 2001-12
First Submitted: June 3, 2004
First Posted: June 4, 2004
Results First Submitted: July 7, 2011
Results First Posted: August 3, 2011
Last Update Posted: November 20, 2017
Last Verified: October 2017

Keywords provided by University of Arkansas:
Multiple Myeloma
DTPACE
Tandem Transplant
Cisplatin
Cyclophosphamide
Dexamethasone
Doxorubicin
Etoposide
Sargramostim
Thalidomide
Melphalan

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Liposomal doxorubicin
Etoposide phosphate
Cisplatin
Dexamethasone
Cyclophosphamide
Doxorubicin
Etoposide
Melphalan
Thalidomide
Dexamethasone acetate
BB 1101
Antineoplastic Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents