CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 147 enrolled
Drug / intervention
filgrastim +7 morebiological
Likely dose
Melphalan 140 mg/m² IV over 20 minutes (first transplant), 200 mg/m² IV over 20 minutes (second transplant); thalidomide 50 mg PO daily (induction, escalated by 50 mg weekly to max 400 mg at bedtime for 35 days; maintenance 50–200 mg daily until progression); dexamethasone 40 mg PO daily days 1–4, 9–12, 17–20; prednisone 50 mg PO every other day (maintenance until progression)AI-extracted
Key inclusion· 6
  • ✓Newly diagnosed multiple myeloma requiring treatment, including smoldering myeloma with progressive disease (>25% increase in M component/Bence-Jones or symptom development)
  • ✓Non-secretory patients with ≥30% bone marrow plasmacytosis or IgM peaks with ≥30% bone marrow plasmacytosis or >3 lytic lesions
  • ✓Age 18–65 years
  • ✓ECOG performance status 0–2, or 3–4 if due solely to bone pain
Key exclusion· 10
  • ✕Untreated, unresolved symptomatic hyperviscosity
  • ✕Hepatitis B positive
  • ✕Creatinine >3 mg/dL (unless in renal failure on dialysis after hydration/hypercalcemia correction)
  • ✕History of cerebrovascular accident, myocardial infarction within 6 months, unstable angina, difficult-to-control congestive heart failure, uncontrollable hypertension, or difficult-to-control cardiac arrhythmia

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

Search/NCT00040937
NCT00040937Phase 2Completed
CompareCT.gov

A Phase II Trial Of Thalidomide/Dexamethasone Induction Followed By Tandem Melphalan Transplant And Prednisone/Thalidomide Maintenance (A BMT Study)

SWOG Cancer Research Network·interventional·Posted Jan 27, 2003·Updated Dec 8, 2016

In Brief

A Phase 2 clinical trial evaluating filgrastim, sargramostim, and 6 other interventions for Multiple Myeloma. Completed, enrolled 147 participants across 141 sites.

Detailed Summary

RATIONALE: Thalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Giving thalidomide before and after peripheral stem cell transplant may be effective in treating newly diagnosed multiple myeloma. PURPOSE: This phase II trial is studying how well giving thalidomide with chemotherapy and peripheral stem cell transplant work in treating patients with newly diagnosed multiple myeloma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartJun 1, 2002
Primary CompletionOct 1, 2008
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 23.4 years ago

Interventions

filgrastimbiological

PBSC collection: 10 mcg/kg SQ days 1-10

sargramostimbiological

PBSC collection: 500 mcg/m2 SQ day 1 through last apheresis 1st and 2nd trans: 500 mcg SC or IV days 6-WBC recovery

cyclophosphamidedrug

PBSC collection: 1 mg/m2 IV over 45-60 mins day 0

dexamethasonedrug

40 mg/d PO days 1-4, 9-12, 17-20

melphalandrug

1. st trans: 140 mg/m2 IV over 20 mins day -1 2. nd trans: 200mg/m2 IV over 20 mins day -1

prednisonedrug

maint: 50 mg/d PO every other day until progression

thalidomidedrug

ind: 50 mg increased by 50 mg every week to max 400 mg PO qhs for 35 days maint: 50 mg/d increased by 50 mg every week to 200 mg PO daily until progression

peripheral blood stem cell transplantationprocedure

2-4 x 10\^6/kg IV day 0