DTPACE Followed by Tandem Transplant With Melphalan (MEL) 200 Versus MEL/Dexamethasone/Thalidomide (DT) Platinol/Adriamycin/Etoposide (PACE) Hybrid and DTPACE Consolidation
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer, Hematology, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/22/2017 |
| Start Date: | June 2001 |
| End Date: | June 2010 |
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
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.
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.
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.
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.
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.
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