A Phase I Study Of Panobinostat/Lenalidomide/Bortezomib/Dex for Relapsed And Relapsed/Refractory Multiple Myeloma

NCT01965353 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2021-09-05

No results posted yet for this study

Summary

This research study is evaluating an investigational drug called "panobinostat" (LBH589) in combination with the standard agents lenalidomide, bortezomib, and dexamethasone as a possible treatment for multiple myeloma.

Conditions

  • Multiple Myeloma in Relapse

Interventions

DRUG

Panobinostat

\- Panobinostat - single oral dose on days 1, 3, 5, 8, 10 and 12 and followed by a 9-day rest period.

DRUG

Dexamethasone

Dexamethasone - oral dose on Days 1, 2, 4, 5, 8, 9, 11 and 12 followed by a 9-day rest period

DRUG

Lenalidomide

Lenalidomide - daily oral dose on Days 1-14 followed by 7-day rest period

DRUG

Bortezomib

Bortezomib - subcutaneous injection, on Days 1, 4, 8, and 11 followed by a 10-day rest period. At least 72 hours should elapse between bortezomib doses, but if needed an interval of 70 hours is permitted

Sponsors & Collaborators

Principal Investigators

  • Jacob Laubach, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2019-03-31
Completion
2021-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01965353 on ClinicalTrials.gov