DTPACE Followed by Tandem Transplant With MEL 200 Versus MEL/DTPACE Hybrid and DTPACE Consolidation

This study has been completed.
Sponsor:
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00083915
First received: June 3, 2004
Last updated: July 7, 2011
Last verified: July 2011
  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. 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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 ] [ Designated as safety issue: No ]
    Compare a new regimen of chemotherapy called DT PACE-Melphalan (new experimental therapy) is better than transplant with Melphalan alone (standard therapy)


Secondary Outcome Measures:
  • Side Effects With DT PACE-Melphalan vs Side Effects With Melphalan Alone [ Time Frame: 3 years depending on start date ] [ Designated as safety issue: No ]
    Compare side effects with the new regimen of DT PACE-Melphalan, compared to melphalan alone


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
  • DCCP
  • Platinol
  • Platinol-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
  • VP-16
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 >50K.
Other Name: Thalomid
Drug: Dexamethasone
40 mg po days 1 - 4 (4 days)
Other Names:
  • Decadron
  • NSC-34521

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 CR/near CR/VGPR rate and event-free and overall survival.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 MUGA Scan or 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 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 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 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, FVC, etc) 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
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: 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:
No publications provided

Responsible Party: Nathan Petty, MS, University_Of_Arkansas
ClinicalTrials.gov Identifier: NCT00083915     History of Changes
Other Study ID Numbers: UARK 2001-12
Study First Received: June 3, 2004
Results First Received: July 7, 2011
Last Updated: July 7, 2011
Health Authority: United States: Food and Drug Administration

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
Etoposide phosphate
Cisplatin
Cyclophosphamide
Dexamethasone
Etoposide
Doxorubicin
Thalidomide
Melphalan
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Immunosuppressive Agents

ClinicalTrials.gov processed this record on September 22, 2014