CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 97 enrolled
Drug / intervention
Cisplatin +6 moredrug
Likely dose
Melphalan 200 mg/m2 IV over <20 minutes (Arm 1) or 50 mg/m2 IV over 20 minutes days -3 and -2 (Arm 2); cisplatin 20 mg/m2 continuous infusion days -3 and -2; cyclophosphamide 800 mg/m2 continuous infusion days -3 and -2; adriamycin 20 mg/m2 continuous infusion days -3 and -2; etoposide 80 mg/m2 continuous infusion days -3 and -2; thalidomide 200 mg PO daily to day +5; dexamethasone 40 mg PO days 1–4AI-extracted
Key inclusion· 6
  • ✓Diagnosis of active multiple myeloma requiring treatment
  • ✓SWOG performance status 0–2, or 3–4 if due solely to bone pain
  • ✓Platelet count ≥100,000/microliters, or <100,000 if due to marrow plasmacytosis
  • ✓Creatinine <3 mg/dl and creatinine clearance ≥30 ml/minute
Key exclusion· 7
  • ✕No prior autologous or allogeneic transplant
  • ✕Recent myocardial infarction (≤6 months), unstable angina, uncontrolled CHF, uncontrolled hypertension, or uncontrolled cardiac arrhythmias
  • ✕History of chronic obstructive or chronic restrictive pulmonary disease
  • ✕Pulmonary function: FEV1, FVC, and DLCO all <50% predicted (or if unable to test, P02 ≤70 on ABG)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00083915
NCT00083915Phase 3Completed
CompareCT.gov

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

University of Arkansas·interventional·Posted Jun 4, 2004·Updated Nov 20, 2017

In Brief

A Phase 3 clinical trial evaluating Cisplatin, Cyclophosphamide, and 5 other interventions for Multiple Myeloma. Completed, enrolled 97 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 4, 2004
Enrollment StartJun 1, 2001
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 9 yearsPosted 22.1 years ago

Interventions

Cisplatindrug

20mg/m2 continuous infusion days -3 and -2.

Cyclophosphamidedrug

800 mg/m2 continuous infusion days -3 and -2.

Adriamycindrug

20mg/m2 continuous infusion -3 and -2.

Etoposidedrug

80mg/m2 continuous infusion -3 and -2.

Melphalandrug

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.

Thalidomidedrug

200mg PO Continuing to Day +5, then hold until platelets \>50 thousand (K).

Dexamethasonedrug

40 mg po days 1 - 4 (4 days)