Primary Plasma Cell LeukemiaPhase 2NCT01553357
Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia
A Phase 2 study testing Lenalidomide, dexamethasone in people with Primary Plasma Cell Leukemia, run by IRCCS Centro di Riferimento Oncologico della Basilicata at 1 site in Italy.
Trial summary
This is an open label, multicenter, exploratory, single arm, two-stage study aiming to explore efficacy and safety of lenalidomide and dexamethasone combination (LD) as first line therapy in previously untreated patients with primary Plasma Cell leukemia (PPCL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Plasma Cell Leukemia
- What is being tested?
- Lenalidomide, dexamethasone
- Type of treatment
- Pill or oral medicine
- How many people
- 23 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2009to Sep 2011
- Phase
- Phase 2
- 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
- Newly diagnosed patients fulfilling the IMWG diagnostic criteria of PPCL
- Age > 18 years
- ECOG performance status of 0,1 or 2
- Life expectancy of at least 12 weeks
Who cannot join
- Myocardial infarction within 6 months prior to enrollment or uncontrolled angina
- Severe uncontrolled ventricular arrhythmias
- ECG evidence of acute ischemia or active conduction system abnormalities
- Female subjects either pregnant or breast-feeding
- Serious medical or psychiatric illness
- Total bilirubin greater than 2.0 mg/dL and/or SGOT or SGPT greater than two and a half times normal (unless due to primary malignancy)
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- History of severe hepatic dysfunction
- Active infections or HIV positivity
- Uncontrolled insulin-dependent diabetes mellitus
- Uncompensated major thyroid or adrenal dysfunction
- Hemodialysis or peritoneal dialysis
- Renal dysfunction (unless due to primary malignancy; in this case, enrollment at the discretion of the principal investigator)
- ECOG performance status of 3 (unless due to primary malignancy; in this case, enrollment at the discretion of the principal investigator)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Lenalidomide and Dexamethasone in Patients With Primary Plasma Cell Leukemia
This is an open label, multicenter, exploratory, single arm, two-stage study aiming to explore efficacy and safety of lenalidomide and dexamethasone combination (LD) as first line therapy in previously untreated patients with primary Plasma Cell leukemia (PPCL).
Read the detailed description
The primary endpoint was response rate according to International Uniform Criteria; secondary endpoints were: i) time to progression (TTP), progression free survival (PFS, and overall survival (OS); ii) percentage of eligible PPCL patients able to mobilize and collect peripheral blood stem cells after LD treatment; iii) percentage of eligible PPCL patients able to undergo autologous or allogeneic stem cells transplantation after LD treatment; iv) serious/severe adverse event (SAEs) rate.
- Conditions
- Primary Plasma Cell Leukemia
- Being tested
- Lenalidomide, dexamethasone
- Keywords
- Plasma cell leukemia, Lenalidomide, Dexamethasone, Multiple myeloma, Bortezomib, Stem cell transplantation
- Medical subject headings
- Leukemia, Plasma Cell, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenalidomide, dexamethasoneDrug
Also called Revlimid
Enrolled patients received lenalidomide at a dose of 25 mg/d for 21 days and oral dexamethasone at a dose of 40 mg on days 1, 8, 15, and 22 for each 28-day cycle. After 4 cycles, responding patients not eligible for SCT continued until 8 cycles of full-dose LD, if tolerated, followed by a maintenance dose of single agent lenalidomide equal to 10 mg/d on days 1-21 of each 28-day cycle.
Patients responding after 4 cycles and eligible for SCT proceeded according to single Centre transplant policy. Patients not responding after 4 cycles or progressing during this treatment were considered off-study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
IMWG criteria
Measured: 4 months
Complete remission rate
IMWG
Measured: 4 months
At least Very good partial remission rate
IMWG
Measured: 4 months
Secondary outcomes (4)
Progression free survival
Median follow-up
Measured: 24 months
Overall survival
Median follow-up
Measured: 24 months
Percentage of patients able to perform stem cell transplantation
Number of eligible patients reaching stem cell transplantation procedure
Measured: 12 months
Safety
Number of severe/serious adverse events
Measured: 4-8 months, according to protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startMar 2009
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Plasma Cell LeukemiaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro di Riferimento Oncologico della Basilicata
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Principal investigator, Pellegrino Musto, IRCCS Centro di Riferimento Oncologico della Basilicata
- Investigators
- Pellegrino Musto, MD, Principal investigator, GIMEMA Multiple Myeloma Working Party
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553357
- Sponsor's protocol ID
- CROB0108/1 -- RV-PCL-PI-350
- Other IDs
- 2008-003246-28, 2008
- Status last verified
- Mar 2012
- First submitted
- 3 Mar 2012
- Last updated
- 14 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Lenalidomide and Dexamethasone in Patients With Primary Plasma Cell Leukemia
- ClinicalTrials.gov ID
- NCT01553357
- Acronym / sponsor ID
- CROB0108/1 -- RV-PCL-PI-350
- Conditions
- Primary Plasma Cell Leukemia
- Keywords
- Plasma cell leukemia, Lenalidomide, Dexamethasone, Multiple myeloma, Bortezomib, Stem cell transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- IRCCS Centro di Riferimento Oncologico della BasilicataUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Mar 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 14 Mar 2012 (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.
This is an open label, multicenter, exploratory, single arm, two-stage study aiming to explore efficacy and safety of lenalidomide and dexamethasone combination (LD) as first line therapy in previously untreated patients with primary Plasma Cell leukemia (PPCL).
Detailed description
The primary endpoint was response rate according to International Uniform Criteria; secondary endpoints were: i) time to progression (TTP), progression free survival (PFS, and overall survival (OS); ii) percentage of eligible PPCL patients able to mobilize and collect peripheral blood stem cells after LD treatment; iii) percentage of eligible PPCL patients able to undergo autologous or allogeneic stem cells transplantation after LD treatment; iv) serious/severe adverse event (SAEs) rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Newly diagnosed patients fulfilling the IMWG diagnostic criteria of PPCL
- Age > 18 years
- ECOG performance status of 0,1 or 2
- Life expectancy of at least 12 weeks
Key exclusion criteria (13 listed)
- Myocardial infarction within 6 months prior to enrollment or uncontrolled angina
- Severe uncontrolled ventricular arrhythmias
- ECG evidence of acute ischemia or active conduction system abnormalities
- Female subjects either pregnant or breast-feeding
- Serious medical or psychiatric illness
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 |
|---|---|---|
| Lenalidomide, dexamethasoneAlso: RevlimidEnrolled patients received lenalidomide at a dose of 25 mg/d for 21 days and oral dexamethasone at a dose of 40 mg on days 1, 8, 15, and 22 for each 28-day cycle. After 4 cycles, responding patients not eligible for SCT continued until 8 cycles of full-dose LD, if tolerated, followed by a maintenance dose of single agent lenalidomide equal to 10 mg/d on days 1-21 of each 28-day cycle. Patients responding after 4 cycles and eligible for SCT proceeded according to single Centre transplant policy. Patients not responding after 4 cycles or progressing during this treatment were considered off-study. | Drug | – |
Primary outcome
Overall response rate
Time frame: 4 months
IMWG criteria
Complete remission rate
Time frame: 4 months
IMWG
At least Very good partial remission rate
Time frame: 4 months
IMWG
4 secondary outcomes
Progression free survival
Time frame: 24 months
Overall survival
Time frame: 24 months
Percentage of patients able to perform stem cell transplantation
Time frame: 12 months
Safety
Time frame: 4-8 months, according to protocol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2012.
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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.
Pellegrino Musto, MD principal investigator
GIMEMA Multiple Myeloma Working Party
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenalidomide, dexamethasone in people with Primary Plasma Cell Leukemia, run by IRCCS Centro di Riferimento Oncologico della Basilicata at 1 site in Italy.
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 4 inclusion and 13 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: finished, as of the sponsor's last update on 14 Mar 2012. 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 Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall response rate (time frame: 4 months). The study lists 3 primary outcomes in all. 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 14 Mar 2012.