NCT02030483

Palbociclib in Combination With Lenalidomide and Dexamethasone for Multiple Myeloma

A Phase 1 Open-Label Study of the Safety and Efficacy of PD 0332991 (Palbociclib) in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Our hypothesis is that treating relapsed or refractory multiple myeloma with PD 0332991 (Palbociclib) in combination with lenalidomide will result will be both effectively inducing myeloma plasma cell death as well maintaining a favorable side effect profile.

Detailed description

This clinical trial is for men and women with multiple myeloma that has returned after treatment (relapsed) or did not respond to prior treatment (refractory). This is a phase 1 study of the addition of the PD 0332991 (Palbociclib) CDK4/CDK6 inhibitor to lenalidomide / dexamethasone treatment in RRMM. The purpose of the study is to determine the effectiveness of the combination of PD 0332991, lenalidomide and dexamethasone (PLD) in treating relapsed/refractory multiple myeloma. PD 0332991 (Palbociclib) is an experimental drug and is a pill taken by mouth. It works by blocking specific growth signals within cancer cells. Lenalidomide (also called Revlimid) is approved for use with dexamethasone for people with multiple myeloma who have received prior therapy. Study participants will receive different doses of Palbociclib and lenalidomide depending on when they enroll in the study. The study will help determine the maximum tolerated dose of the combination of the study drugs. Treatment schedule (treatment cycles are 28 days): * Palbociclib daily for Days 1-14 of each cycle * Lenalidomide daily for Days 8-21 (or Days 1-21, depending on dose level) of each cycle * Dexamethasone on Days 1, 8, 15 and 22 of each cycle. Participants will continue on study treatment as long as they are responding to therapy and not experiencing unacceptable side effects.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Palbociclib	Palbociclb will be given at predefined dose level of 75 mg, 100 mg, 125 mg, or 150 mg days 1-14 every 28 days (days 0-14 for cycle 1 only).
DRUG	Dexamethasone	20 mg by mouth on days 1, 8, 15 and 22 of a 28-day cycle (Day 1 dosing is omitted for cycle 1 only).
DRUG	Lenalidomide	Lenalidomide at predefined dose level of 5mg, 10 mg, 15 mg, 25 mg daily for days 8-21 (or days 1-21, depending on dose level cohort).

Timeline

• Start date: 2014-02-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2014-01-08
• Last updated: 2018-08-22

Locations

1 site across 1 country: United States