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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Transplant With DT PACE-Melphalan Regimen of Chemotherapy vs. Transplant With Melphalan Alone.

Outcome Description:

Compare a new regimen of chemotherapy called DT PACE-Melphalan (new experimental therapy) is better than transplant with Melphalan alone (standard therapy)

Outcome Time Frame:

3 years depending on start date

Safety Issue:

No

Principal Investigator

Frits van Rhee, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

UAMS

Authority:

United States: Food and Drug Administration

Study ID:

UARK 2001-12

NCT ID:

NCT00083915

Start Date:

June 2001

Completion Date:

June 2010

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • DTPACE
  • Tandem Transplant
  • Cisplatin
  • Cyclophosphamide
  • Dexamethasone
  • Doxorubicin
  • Etoposide
  • Sargramostim
  • Thalidomide
  • Melphalan
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

University of Arkansas for Medical Sciences/MIRTLittle Rock, Arkansas  72205