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NCT00833833: Phase 1/2: MTD, Safety, and Efficacy of Pomalidomide (CC-4047) +/- Dexamethasone RRMM

Updated: Sep 27, 2022



NCT00833833: Phase 1/2: MTD, Safety, and Efficacy of Pomalidomide (CC-4047) Alone or With Low-dose Dexamethasone in Patients With Relapsed and Refractory Multiple Myeloma


The purpose of this study is to determine the maximum tolerated dose and effectiveness of the study drug (CC-4047) Alone Or in Combination With Low-dose Dexamethasone as treatment for patients with relapsed and refractory multiple myeloma


ClinicalTrials.gov Identifier: NCT00833833

Official Title: A Phase I/II Multicenter, Randomized, Open Label, Dose-Escalation Study To Determine The Maximum Tolerated Dose, Safety, And Efficacy Of CC-4047 Alone Or In Combination With Low-Dose Dexamethasone In Patients Wth Relapsed And Refractory Multiple Myeloma Who Have Received Prior Treatment That Includes Lenalidomide And Bortezomib

Click here for details on ClinicalTrials.gov

 

Dexamethasone : National Cancer Institute

Dexamethasone : MedlinePlus Drug Information

Pomalidomide: National Cancer Institute

Pomalidomide: MedlinePlus Drug Information

 

Pomalidomide alone or in combination with low-dose dexamethasone in relapsed and refractory multiple myeloma: a randomized phase 2 study

Blood; 2014

POM+LoDEX was effective and generally well tolerated and provides an important new treatment option for RRMM patients who have received multiple prior therapies

https://pubmed.ncbi.nlm.nih.gov/24421329/


Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and moderate renal impairment: a pooled analysis of three clinical trials.

Leuk Lymphoma. 2016

https://pubmed.ncbi.nlm.nih.gov/27267105/

https://www.themyelomaclinicaltrials.com/single-post/nimbus



Phase 1 study of pomalidomide MTD, safety, and efficacy in patients with refractory multiple myeloma who have received lenalidomide and bortezomib

Blood, 2013

Pomalidomide 4 mg per day on days 1 to 21 of each 28-day cycle, with or without dexamethasone (40 mg/week), has encouraging activity with manageable toxicity in RRMM, including those refractory to both lenalidomide and bortezomib.

https://pubmed.ncbi.nlm.nih.gov/23243282/



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