CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
thalomid +3 moredrug
Likely dose
thalomid 50mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00538733
NCT00538733Phase 2Completed
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A Phase II Study of Thalidomide (THALOMID®), Clarithromycin (BIAXIN®), Lenalidomide(REVLIMID®), and Dexamethasone (DECADRON®) for Subjects With Newly Diagnosed Multiple Myeloma

Weill Medical College of Cornell University·interventional·Posted Oct 3, 2007·Updated May 24, 2021

In Brief

A Phase 2 clinical trial evaluating thalomid, lenalidomide, and 2 other interventions for Multiple Myeloma. Completed, enrolled 26 participants across 1 site.

Detailed Summary

Study Objectives 1. Evaluate the efficacy of the combination of thalidomide (Thalomid®), clarithromycin (Biaxin®), lenalidomide (Revlimid®), and dexamethasone (Decadron®) as an induction therapy for patients with newly diagnosed multiple myeloma (MM). 2. Evaluate the efficacy of the addition of thalidomide (Thalomid®) to BiRD combination therapy as a therapy to increase the complete response rate for patients with newly diagnosed multiple myeloma. 3. Evaluate the safety of the combination of clarithromycin, lenalidomide, dexamethasone, and thalidomide as a therapy for patients with newly diagnosed MM

Study Details

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

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 3, 2007
Enrollment StartOct 1, 2007
Primary CompletionJul 1, 2010
Study CompletionSep 17, 2020
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 18.7 years ago

Interventions

thalomiddrug

Cycles 1-4 • Thalidomide (50mg daily for days 1-7, thereafter 100mg daily for days 8-28 of the first 28 day cycle. Thalidomide will then be given at 100mg/daily for days 1-28 for each subsequent cycle)

lenalidomidedrug

During T-BIRD Phase (Cycles 1-4, 5-6, and in the case of T-BIRD re-initiation) • Lenalidomide (25 mg daily days 1-21 of every 28 day cycle) During BiRD phase • 25mg daily days 1-21 of every 28 day cycle) During Maintenance Phase • 25 mg daily for days 1-21 out of a 28 day cycle

clarithromycindrug

During T-BiRD Phase • Clarithromycin (500mg twice daily for each 28 day cycle) During BiRD Phase: • Clarithromycin (500mg twice daily for each 28 day cycle)

dexamethasonedrug

During T-BIRD Phase (Cycles 1-4, 5-6, and in the case of T-BIRD re-initiation) • Dexamethasone (40 mg daily on day 1, 8, 15 and 22 of each 28 day cycle) During BiRD Phase: • Dexamethasone (40 mg daily on day 1, 8, 15 and 22 of each 28 day cycle) During Maintenance Phase • Dexamethasone 20 mg weekly (days 1,8, 15, 22 out of a 28 day cycle)