Palbociclib in Combination With Lenalidomide and Dexamethasone for Multiple Myeloma (PD + RD)
|ClinicalTrials.gov Identifier: NCT02030483|
Recruitment Status : Terminated (The company providing one of the study drugs withdrew its support due to low enrollment. Therefore, we had to close the study due to lack of funding.)
First Posted : January 8, 2014
Last Update Posted : August 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Palbociclib Drug: Dexamethasone Drug: Lenalidomide||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||February 2014|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
Experimental: All Subjects
Palbociclib (PD 0332991) will be given at a prespecified dose by cohort orally on days 1-14 of a 28-day cycle. For cycle 1 only, PD 0332991 will start on Day 0. Lenalidomide (Revlimid®) will be given at a prespecified dose by cohort orally on days 8-21 of a 28-day cycle (or days 1-21 as defined by dose cohort level). Dexamethasone (Decadron®) will be given orally at a dose of 20 mg on days 1, 8, 15, and 22 of a 28-day cycle. For cycle 1 only, the dexamethasone will be omitted on Day 1.
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).
Other Name: PD 0332991
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).
Other Name: Decadron
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).
Other Name: Revlimid
- Establish a maximum-tolerated dose of Palbociclib, lenalidomide, and dexamethasone for patients with relapsed or refractory multiple myeloma [ Time Frame: 3 years ]The primary endpoint of objective determination of the maximum tolerated dose will be assessed through safety reports. The frequency of subjects experiencing toxicities will be tabulated. Toxicities will be assessed and graded according to CTCAE v. 4.0 terminology
- Number of subjects who demonstrate a response to Palbociclib, Lenalidomide, and dexamethasone [ Time Frame: 3 years ]Capture the number of subjects who demonstrate an improvement (response) in myeloma when being treated with palbociclib, lenalidomide, and dexamethasone.
- Survival duration without disease progression of relapsed/refractory study subjects treated with palbociclib, lenalidomide, and dexamethasone [ Time Frame: 5 years ]Measure the progression-free survival of subjects following treatment with a combination of palbociclib, lenalidomide, and dexamethasone in relapsed or refractory multiple myeloma.
- Toxicity profile associated with the study regimen (palbociclib, lenalidomide, and dexamethasone) [ Time Frame: 3 years ]Determine the regimen-associated adverse events of the Palbociclib, lenalidomide, and dexamethasone treatment
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02030483
|United States, New York|
|Weill Cornell Medical College|
|New York, New York, United States, 10065|
|Principal Investigator:||Tomer M Mark, MD||Weill Medical College of Cornell University|