⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma

Official Title: Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma

Study ID: NCT01832727

Study Description

Brief Summary: The primary objectives are: Phase 1b: * To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of oprozomib given orally, once daily, on 2 different schedules. * To evaluate safety and tolerability Phase 2: * To estimate the overall response rate (ORR). * To evaluate safety and tolerability

Detailed Description: The purpose of the Phase 1b portion of the study was to determine the maximum tolerated dose (MTD), the recommended phase 2 dose (RP2D), safety, and pharmacokinetics (PK) of oprozomib administered orally once daily in combination with dexamethasone, in participants with relapsed and/or refractory multiple myeloma, using a 3 + 3 dose-escalation scheme with and without step-up dosing. The MTD was defined as the highest dose level at which fewer than 33% of participants had a dose-limiting toxicity (DLT).

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States

H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States

University of Kansas Cancer Center and Medical Pavilion, Westwood, Kansas, United States

Center for Cancer and Blood Disorders, Bethesda, Maryland, United States

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Massachusetts General Hospital, Boston, Massachusetts, United States

Karmanos Cancer Institute, Detroit, Michigan, United States

Division of Hematology/ Oncology, UNC at Chapel Hill, Chapel Hill, North Carolina, United States

Gabrail Cancer Center Research, Canton, Ohio, United States

Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States

CHRU, Hopital Huriez - Department of Hematology, Lille CEDEX, , France

CHU Hotel Dieu - Service d'Hematologie Clinique, NANTES Cedex, , France

CHU de NANCY - Hopital de BRABOlS, Vandoeuvre Les Nancy, , France

Contact Details

Name: MD

Affiliation: Amgen

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: