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Trial registered on ANZCTR


Registration number
ACTRN12611000597998
Ethics application status
Approved
Date submitted
7/06/2011
Date registered
9/06/2011
Date last updated
9/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A phase II study of lenalidomide and prednisolone as post-autologous stem cell transplant (ASCT) maintenance therapy for patients with Multiple Myeloma incorporating residual disease monitoring.
Scientific title
A phase II study of lenalidomide and prednisolone as post-ASCT maintenance therapy for patients with Multiple Myeloma incorporating residual disease monitoring.
Secondary ID [1] 262336 0
None.
Universal Trial Number (UTN)
Trial acronym
LEOPARD study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Residual Multiple Myeloma in patients post autologous stem cell transplant. 268039 0
Condition category
Condition code
Blood 268171 268171 0 0
Haematological diseases
Cancer 268180 268180 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lenalidomide will be commenced orally at a dose of 10mg daily for 6 weeks following stem cell transplant. If this dose is well tolerated it may be increased at the discretion of the attending haematologist 2 months following commencement. Converseley, in patients with suspected lenalidomide toxicity, dose reductions in 5mg steps will be allowed for management of myelo-suppression. Dose re-escalation of lenalidomide at the discretion of the attending haematologist will be allowed subsequently where toxicity abates.
Alternate-day prednisolone will start at a dose of 50mg. No escalation of prednisolone will be allowed to manage toxicities. Patients intolerantof prednisolone can continue on single agent lenalidomide.
Intervention code [1] 266725 0
Prevention
Intervention code [2] 266732 0
Treatment: Drugs
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266916 0
To document changes in the depth of disease response in MM patients who receive lenalidomide and alternate-day prednisolone maintenace therapy post stem cell transplant.
Timepoint [1] 266916 0
Until acceptable toxicity or relapse/progressive disease judged by blood analysis, physical examinations, bone marrow analysis and adverse events experienced by the patient.
Secondary outcome [1] 276613 0
To subsequently quantify minimal residual disease in patients who have achieved complete remission.
Timepoint [1] 276613 0
Until acceptable toxicity or relapse/progressive disease, by free lite chains, heavy lite and plasma cells in the bone marrow and peripheral blood throughout the study and at investigators discretion.
Secondary outcome [2] 276614 0
To evaluate kinetics of responses and loss of response and correlate with clinical outcome.
Timepoint [2] 276614 0
Until acceptable toxicity or relapse/progressive disease. By blood and bone marrow analysis throughout the study and at investigators discretion.
Secondary outcome [3] 276615 0
To document progression free survival.
Timepoint [3] 276615 0
Until acceptable toxicity or relapse/progressive disease, judged by clinical review, blood analysis, physical examinations, bone marrow analysis and adverse events experienced by the patient.
Secondary outcome [4] 276616 0
To evaluate the utility of ASO-PCR to detect minmal residual disease in patients who have achieved complete remission.
Timepoint [4] 276616 0
Until acceptable toxicity or relapse/progressive disease.
Secondary outcome [5] 276617 0
To compare response rates to those in comparable historical cohorts of patients receiving no post stem cell transplant therapy.
Timepoint [5] 276617 0
Until acceptable toxicity or relapse/progressive disease, judged throughout the study by clinical review, blood analysis, physical examinations, bone marrow analysis and adverse events experienced by the patient.
Secondary outcome [6] 276618 0
To prospectively evaluate lymphocyte subsets, cytokines and T-cell immune reconstitution, T-cell clonality and T-Reg populations following stem cell transplant in patients receiving lenalidomide and prednisolone maintenance therapy.
Timepoint [6] 276618 0
Until acceptable toxicity or relapse/progressive disease judged by blood and bone marrow analysis.
Secondary outcome [7] 276619 0
To sequentially evaluate lenalidomide and prednisolone related modulation of haemostatic correlates of venous thrombo embolism risk.
Timepoint [7] 276619 0
Until acceptable toxicity or relapse/progressive disease judged by blood analysis throughout the study.
Secondary outcome [8] 276620 0
To correlate pre stem cell transplant myeloma tumour cell protein expression profiles with attainment of post stem cell transplant complete remission
Timepoint [8] 276620 0
Until acceptable toxicity or relapse/progressive disease by blood and bone marrow analysis throughout the study.

Eligibility
Key inclusion criteria
At registration pre-ASCT
-Age over 17 years
-Diagnosis of multiple myeloma as per IMWG
criteria
-No more than 12 months total prior standard-
dose chemotherapy.
-No previous high-dose chemotherapy or
autologous transplantation procedure.
-ECOG performance status 0, 1, or 2.
-Normal liver and kidney function (within 2 x the
institutional upper limit of normal).
-No contraindication to the use of any of the study
drugs
-Greater than or equal to 2.0 x 106/kg CD34+ stem cells available for
infusion.
-Written informed consent.

To commence RAP post-ASCT
-Have reached Day 42 post-ASCT with evidence of
haemopoietic reconstitution (neutrophils > 1.5 x 109/litre
and platelets unsupported >50 x 109/litre).
-No evidence of progressive myeloma.
-All women of childbearing potential must agree to
have a negative pregnancy test in the 24hrs before
commencing lenalidomide,
take adequate precautions to prevent pregnancy,
not plan on conceiving children during or within 6 months
following lenalidomide.
-All male participants must use barrier contraception during
and for 4 weeks after completion of lenalidomide.
-No contraindication to prednisolone or lenalidomide
-Have an ECOG performance status of 0 – 2.
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Patients with monoclonal gammopathy of uncertain
significance.
-Patients with progressive MM pre or post stem cell
transplant.
-Patients whose general condition makes them unsuitable
for intensive treatment e.g. significant cardiac or
pulmonary disease.
-Active infections or other illnesses that would preclude
conditioning chemotherapy or maintenance therapy
administration or patient compliance.
-Pregnant or lactating women.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/12/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267213 0
Commercial sector/Industry
Name [1] 267213 0
Celgene Pty Ltd
Country [1] 267213 0
Australia
Funding source category [2] 267214 0
Hospital
Name [2] 267214 0
Malignant haematology and stem cell transplant Service
Country [2] 267214 0
Australia
Primary sponsor type
Hospital
Name
Malignant haematology and stem cell transplant Service
Address
Prof. Andrew Spencer
Malignant haematology and stem cell transplant service
The Alfred Hospital
Ground Floor, William Buckland Building
Commercial Rd
Prahran, Victoria, 3181
Country
Australia
Secondary sponsor category [1] 266290 0
Hospital
Name [1] 266290 0
Malignant haematology and stem cell transplant Service
Address [1] 266290 0
Prof. Andrew Spencer
Malignant haematology and stem cell transplant service
The Alfred Hospital
Ground Floor, William Buckland Building
Commercial Rd
Prahran, Victoria, 3181
Country [1] 266290 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269205 0
Alfred Health Human Research and Ethics Committee
Ethics committee address [1] 269205 0
The Alfred Hospital
Ground Floor, Linay Pavilion
Commercial Rd
Prahran, Victoria, 3181
Ethics committee country [1] 269205 0
Australia
Date submitted for ethics approval [1] 269205 0
Approval date [1] 269205 0
Ethics approval number [1] 269205 0

Summary
Brief summary
A post stem cell transplant maintenance study with lenalidomide in combination with alternate day prednisolone.
All patients will be registered prior to stem cell transplant, be planned for single high dose Melphalan-conditioned stem cell transplant and have no evidence of disease progression at re-staging 6 weeks post transplant.
Oral lenalidomde will commence at a dose of 10mg daily. After 2 months following commencement, escalation or reduction of lenalidomide can be made at the discretion of the treating doctor, depending on tolerance or intolerance of the treatment. Alternate day prednisolone will commence at a dose of 50mg on alternate days with lenalidomide. No dose escalation of prednisolone is planned. Dose reductions are permitted to manage any side effects according to the study protocol. This treatment will continue until unacceptable side effects or disease relapse/progressive disease.
Pre transplant, all patients will undergo disease restaging with blood tests and bone marrow aspirate. Bloods for serum storage for DNA analysis will be obtained. 6 weeks post transplant patients with adequate recovery will undergo rstaging of their disease with blood testing and bone marrow, to confirm continuing disease response. Patients with disease progression evident on re-staging will not be eligible for treatment on this study. On study, all patients will continue to be evaluated every 4 weeks with repeat blood testsfor response and monitoring until disease progression.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32714 0
Address 32714 0
Country 32714 0
Phone 32714 0
Fax 32714 0
Email 32714 0
Contact person for public queries
Name 15961 0
Nola Kennedy
Address 15961 0
The Alfred Hospital
1st Floor, William Buckland Building
Commercial Rd,
Prahran, Victoria, 3181
Country 15961 0
Australia
Phone 15961 0
+61 3 9076 7712
Fax 15961 0
Email 15961 0
[email protected]
Contact person for scientific queries
Name 6889 0
Nola Kennedy
Address 6889 0
The Alfred Hospital
1st Floor, William Buckland Building
Commercial Rd,
Prahran, Victoria, 3181
Country 6889 0
Australia
Phone 6889 0
+61 3 9076 7712
Fax 6889 0
Email 6889 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCereblon pathway biomarkers and immune profiles in patients with myeloma receiving post-ASCT lenalidomide maintenance (LEOPARD).2021https://dx.doi.org/10.1080/10428194.2021.1948030
N.B. These documents automatically identified may not have been verified by the study sponsor.