Multiple MyelomaPhase 1PD + RDNCT02030483
Palbociclib in Combination With Lenalidomide and Dexamethasone for Multiple Myeloma
A Phase 1 study testing Palbociclib, Dexamethasone and Lenalidomide in people with Multiple Myeloma, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Palbociclib, Dexamethasone and Lenalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Jul 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must voluntarily sign and understand written informed consent.
- Subject is ≥18 years at the time of signing the consent form.
- Subject has histologically confirmed multiple myeloma that expresses phosphorylated retinoblastoma protein (pRb), as assessed using a historical biopsy sample if available, or a freshly obtained tumor sample.
- Subject has relapsed or refractory myeloma as defined by progression of disease either after prior therapy or lack of response to currently used therapy.
- Subject must have received and relapsed or progressed after prior treatment with bortezomib.
- Subject has measurable disease as defined by > 0.5 g/dL serum monoclonal protein, >10 mg/dL involved serum free light chain (either kappa or lambda) provided that the serum free light chain ratio is abnormal, >0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s) of at least 1cm in greatest dimension as measured by either CT scanning or MRI.
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- Subject has a Karnofsky performance status ≥60% (>50% if due to bony involvement of myeloma
- Subject is able to take prophylactic anticoagulation as detailed in section 9.1 (patients intolerant to aspirin may use warfarin or low molecular weight heparin).
- Subject is registered into the mandatory Revlimid REMS®program, and is willing and able to comply with the requirements of Revlimid REMS® program.
- If subject is a female of childbearing potential (FCBP), she must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with females of child bearing potential even if they have had a successful vasectomy. Men must agree to continue birth control for 90 days post-last dose of PD-0332991
- All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program.
- Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.
- Subject has a life expectancy ≥ 3 months
- Subjects must meet the following laboratory parameters:
- Absolute neutrophil count (ANC) ≥750 cells/mm3 (1.0 x 109/L)
- Platelet count ≥ 75,000/mm3 (75 x 109/L)
- Serum SGOT/AST <3.0 x upper limits of normal (ULN)
- Serum SGPT/ALT <3.0 x upper limits of normal (ULN)
- Serum creatinine clearance, (either calculated or directly measured). ≥ 60cc/min
- Serum total bilirubin <2.0 mg/dL (34 μmol/L)
Who cannot join
- Subject has immeasurable MM (no measurable monoclonal protein, free light chains in blood or urine, or measureable plasmacytoma on radiologic scanning).
- Subject has a prior history of other malignancies unless disease free for ≥ 5 years, except for basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or localized prostate cancer with Gleason score < 7 with stable prostate specific antigen (PSA) levels.
- Subject has had myocardial infarction within 6 months prior to enrollment , or NYHA(New York Hospital Association) Class III or IV heart failure, Ejection Fraction < 35%, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Female subject who is pregnant or lactating.
- Subject has known HIV infection
- Subject has known active hepatitis B or hepatitis C infection.
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- Subject has active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program.
- Subject has known hypersensitivity to dexamethasone or lenalidomide.
- Subject has a history of thromboembolic event within the past 4 weeks prior to enrollment.
- Subject has any clinically significant medical or psychiatric disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent.
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10065
About this study
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
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.
Read the 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
- Being tested
- Palbociclib, Dexamethasone, Lenalidomide
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalbociclibDrug
Also called PD 0332991
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).
DexamethasoneDrug
Also called Decadron
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).
LenalidomideDrug
Also called Revlimid
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).
| Study group | Role | What they receive |
|---|---|---|
| All Subjects | Experimental | 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. Receives: Drug: Palbociclib; Drug: Dexamethasone; Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish a maximum-tolerated dose of Palbociclib, lenalidomide, and dexamethasone for patients with relapsed or refractory multiple myeloma
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
Measured: 3 years
Secondary outcomes (3)
Number of subjects who demonstrate a response to Palbociclib, Lenalidomide, and dexamethasone
Capture the number of subjects who demonstrate an improvement (response) in myeloma when being treated with palbociclib, lenalidomide, and dexamethasone.
Measured: 3 years
Survival duration without disease progression of relapsed/refractory study subjects treated with palbociclib, lenalidomide, and dexamethasone
Measure the progression-free survival of subjects following treatment with a combination of palbociclib, lenalidomide, and dexamethasone in relapsed or refractory multiple myeloma.
Measured: 5 years
Toxicity profile associated with the study regimen (palbociclib, lenalidomide, and dexamethasone)
Determine the regimen-associated adverse events of the Palbociclib, lenalidomide, and dexamethasone treatment
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2016
- Study completionJul 2016
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation, Pfizer
- Responsible party
- Sponsor
- Investigators
- Tomer M Mark, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030483
- Sponsor's protocol ID
- 1306014004
- Other IDs
- WS2335828, RV-MM-PI-0675
- Acronym
- PD + RD
- Status last verified
- Aug 2018
- First submitted
- 19 Dec 2013
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02030483
- Acronym / sponsor ID
- PD + RD / 1306014004
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Celgene Corporation, Pfizer
- Study start
- Feb 2014 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 8 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Subjects | Experimental | Drug: Palbociclib, Drug: Dexamethasone, Drug: LenalidomidePalbociclib (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Subject must voluntarily sign and understand written informed consent.
- Subject is ≥18 years at the time of signing the consent form.
- Subject has histologically confirmed multiple myeloma that expresses phosphorylated retinoblastoma protein (pRb), as assessed using a historical biopsy sample if available, or a freshly obtained tumor sample.
- Subject has relapsed or refractory myeloma as defined by progression of disease either after prior therapy or lack of response to currently used therapy.
- Subject must have received and relapsed or progressed after prior treatment with bortezomib.
Key exclusion criteria (11 listed)
- Subject has immeasurable MM (no measurable monoclonal protein, free light chains in blood or urine, or measureable plasmacytoma on radiologic scanning).
- Subject has a prior history of other malignancies unless disease free for ≥ 5 years, except for basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or localized prostate cancer with Gleason score < 7 with stable prostate specific antigen (PSA) levels.
- Subject has had myocardial infarction within 6 months prior to enrollment , or NYHA(New York Hospital Association) Class III or IV heart failure, Ejection Fraction < 35%, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Female subject who is pregnant or lactating.
- Subject has known HIV infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PalbociclibAlso: PD 0332991Palbociclb 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 | All Subjects |
| DexamethasoneAlso: Decadron20 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 | All Subjects |
| LenalidomideAlso: RevlimidLenalidomide 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). | Drug | All Subjects |
Primary outcome
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
3 secondary outcomes
Number of subjects who demonstrate a response to Palbociclib, Lenalidomide, and dexamethasone
Time frame: 3 years
Survival duration without disease progression of relapsed/refractory study subjects treated with palbociclib, lenalidomide, and dexamethasone
Time frame: 5 years
Toxicity profile associated with the study regimen (palbociclib, lenalidomide, and dexamethasone)
Time frame: 3 years
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomer M Mark, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Palbociclib, Dexamethasone and Lenalidomide in people with Multiple Myeloma, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish a maximum-tolerated dose of Palbociclib, lenalidomide, and dexamethasone for patients with relapsed or refractory multiple myeloma (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.