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Trial registered on ANZCTR


Registration number
ACTRN12616000777493
Ethics application status
Approved
Date submitted
26/03/2015
Date registered
15/06/2016
Date last updated
8/10/2019
Date data sharing statement initially provided
8/10/2019
Date results information initially provided
8/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Lenalidomide consolidation post allogeneic stem cell transplant for patients with high risk multiple myeloma failing to achieve stringent Complete Response
Scientific title
Safety and tolerability of lenalidomide consolidation post allogeneic stem cell transplant for patients with high risk multiple myeloma failing to achieve stringent Complete Response
Secondary ID [1] 286418 0
RV-003607
Universal Trial Number (UTN)
U1111-1168-7471
Trial acronym
Lenalidomide post alloSCT for MM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myeloma 294586 0
Condition category
Condition code
Cancer 294886 294886 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment commences approx. 180 days post stem cell transplant.

Lenalidomide will be dosed at 10mg orally daily for 21 of 28 days for cycle #1 (28 day cycle) and escalated to 15mg daily for 21 of 28 days for cycle #2 onwards. Cycles will continue to a maximum of 10, or until disease progression, unacceptable toxicity or death.

Dexamethasone will be given for first two cycles only at a dose of 40mg orally weekly in cycle#1 and 20mg weekly in cycle #2.
Intervention code [1] 291491 0
Treatment: Drugs
Comparator / control treatment
no comparitor
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294640 0
To explore the safety and tolerability of lenalidomide administration post alloSCT with particular reference to graft versus host disease and haematological toxicity.

Assessment of outcome measured by blood tests (including B2 Microglobulin, LDH, albumin, immune studies of peripheral blood, chimerism), bone marrow aspirate and trephine, physical examination and DVT assessment, EORTC QLQ-MY20, EORTC QLQ-C30 and FACT-BMT quality of life questionnaire responses, disease progression assessment (including serum electrophoresis, serum free lite and heavy lite measurement) and incidence of adverse events.
Commonly reported adverse events related to Lenalidomide use include pneumonia, upper respiratory tract infection, urinary tract infection, thrombocytopenia, neutropenia, cough, anemia, peripheral edema, nausea, edema, vomiting, muscle cramps, diarrhea, constipation, pruritus, hypokalemia, arthralgia, insomnia, dizziness, nasopharyngitis, dyspnea, headache, limb pain, pharyngitis, skin rash, weakness, abdominal pain, dyspnea on exertion, back pain, epistaxis, fatigue, anorexia, and xeroderma. Adverse events resulting from graft-versus-host-disease include damage to the liver, skin, mucosa, and the gastrointestinal tract. Assessment of adverse events will be through medical examination and blood testing.
Timepoint [1] 294640 0
180 days post allo-SCT at cycles 1, 2, 3, 6, 10 and end of study (EoS at relapse/progressive disease, unacceptable toxicity/serious adverse event or death).
Secondary outcome [1] 313781 0
Progression free survival.

Assessed through blood, urine and bone marrow samples along with radiological assessment of bone lesions and plasmacytomas where relevant.
Timepoint [1] 313781 0
Assessments will be on a monthly basis until end of study at relapse/progressive disease, unacceptable toxicity/serious adverse event or death.
Secondary outcome [2] 313782 0
Change in depth of disease response and time to maximal response (composite outcome).

Assessed through blood, urine and bone marrow samples along with radiological assessment of bone lesions and plasmacytomas where relevant.
Timepoint [2] 313782 0
Assessments will be on a monthly basis until end of study at relapse/progressive disease, unacceptable toxicity/serious adverse event or death
Secondary outcome [3] 313783 0
Duration of response as measured by disease progression assessment (including serum electrophoresis, serum free lite and heavy lite measurement) and incidence of adverse events
Timepoint [3] 313783 0
Assessments will be on a monthly basis until end of study at relapse/progressive disease, unacceptable toxicity/serious adverse event or death
Secondary outcome [4] 313896 0
Overall Survival
Timepoint [4] 313896 0
Until end of study at relapse/progressive disease, unacceptable toxicity/serious adverse event or death

Eligibility
Key inclusion criteria
Pre allo-SCT

1. Age >18 years of age

2. Diagnosis of multiple myeloma as per IMWG criteria:
a. Clonal plasma cells greater than 10%
b. Presence of serum and/or urinary monoclonal protein (except in patients with true non-secretory multiple myeloma), and
c. Evidence of end-organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically
i.[C] Hypercalcaemia: serum calcium greater than or equal to 11.5mg/100ml or
ii.[R] Renal insufficiency: serum creatinine > 173 micro mol/l or
iii.[A] Anaemia: normocytic, normochromic with a haemoglobin value of >20g/l below the lower limit of normal or a haemoglobin value <100g/l or
iv.[B] Bone lesions: lytic lesions, severe osteopenia or pathologic fractures.

3. Plan to undergo tandem autologous and allogeneic SCT

4. No known contraindication to study drugs

Post allo-SCT -

5. ECOG 0-2

6. Undergone tandem autologous and allogeneic SCT

7. Reached day 180 post allogeneic SCT AND be off all immunosuppression (including systemic steroids) for >2 weeks AND have failed to achieve stringent complete response.

8. Adequate renal function (<2 x institutional upper limit of normal)

9. Adequate liver function (<3 x institutional upper limit of normal)

10. Platelet count > 75 x 10^9, absolute neutrophils count > 1.5 x 10^9

11. Patient has voluntarily agreed and has given written informed consent

12. All women of childbearing potential (WOCBP)** must agree to have two negative pregnancy tests (the 1st pregnancy test must be done 10-14 days and 2nd must be done within 24 hours of commencing lenalidomide) before commencing lenalidomide and use two reliable methods of contraception simultaneously or to practice complete abstinence from any sexual contact during the following time periods related to this study:
1) for at least 28 days before starting study;
2) while participating in the study;
3) dose interruptions; and
4) for at least 28 days after study treatment discontinuation. The two methods of reliable contraception must include one highly effective method and one additional effective method.

All male participants must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Post allo-SCT

1. Current active graft versus host disease (acute or chronic) requiring immunosuppression

2. Prior acute graft versus host disease grade II-IV

3. Received donor lymphocyte infusion (DLI) within 8 weeks of commencing study drug

4. Uncontrolled medical illness or infections

5. Relapsed/progressive myeloma

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients who are eligible and provide consent will be enrolled. All patients will receive the same treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3609 0
The Alfred - Prahran
Recruitment postcode(s) [1] 9398 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 290988 0
Commercial sector/Industry
Name [1] 290988 0
Celgene Pty Ltd
Address [1] 290988 0
Level 7
607 St Kilda Road
Melbourne VIC
3004
Country [1] 290988 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
55 Commercial Road
Melbourne VIC
3004
Country
Australia
Secondary sponsor category [1] 289668 0
Commercial sector/Industry
Name [1] 289668 0
Celgene Pty Ltd
Address [1] 289668 0
Level 7
607 St Kilda Road
Melbourne VIC
3004
Country [1] 289668 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292577 0
Alfred Hospital Ethic Committee
Ethics committee address [1] 292577 0
55 Commercial Road
Melbourne VIC
3004
Ethics committee country [1] 292577 0
Australia
Date submitted for ethics approval [1] 292577 0
Approval date [1] 292577 0
26/06/2014
Ethics approval number [1] 292577 0
205/14

Summary
Brief summary
This study proposes to explore the safety and efficacy of lenalidomide consolidation post allogeneic stem cell transplant in patients with high risk multiple myeloma who fail to achieve stringent complete response.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above and have a diagnosis of multiple myeloma for which you plan to undergo stem cell transplantation.

Study details
All participants in this study will commence treatment with Lenalidomide 180 days after stem cell transplantation. Lenalidomide is a chemotherapy drug which is taken orally at an initial dose of 10mg daily for 21 of 28 days (1 cycle), increasing to 15mg for subsequent treatment cycles. This will be taken in combination with weekly oral dexamethasone for the first 2 cycles. Treatment will continue until any of the following occurs:
a. Unacceptable toxicity/adverse event that may cause severe or permanent harm which rule out continuation of the study drug
b. Relapse/progressive disease and alternative myeloma treatment is required
c. Death
d. The study may also be terminated early if safety concerns emerge with this treatment

Participants will be regularly monitored until relapse or end of treatment in order to evaluate the safety and tolerability of the treatment, as well as disease response.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56062 0
Prof Andrew Spencer
Address 56062 0
Malignant Haematology and Stem Cell Transplantation Service,
Ground Floor, South Block,
Alfred Hospital,
55 Commercial Road,
Melbourne VIC 3004
Country 56062 0
Australia
Phone 56062 0
+61 3 9076 3451
Fax 56062 0
+61 3 9076 2298
Email 56062 0
aspencer@netspace.net.au
Contact person for public queries
Name 56063 0
Ms Nola Kennedy
Address 56063 0
Malignant Haematology and Stem Cell Transplantation Service,
Ground Floor, South Block,
Alfred Hospital,
55 Commercial Road,
Melbourne VIC 3004
Country 56063 0
Australia
Phone 56063 0
+61 3 9076 2217
Fax 56063 0
+61 3 9076 5531
Email 56063 0
n.kennedy@alfred.org.au
Contact person for scientific queries
Name 56064 0
Prof Andrew Spencer
Address 56064 0
Malignant Haematology and Stem Cell Transplantation Service,
Ground Floor, South Block,
Alfred Hospital,
55 Commercial Road,
Melbourne VIC 3004
Country 56064 0
Australia
Phone 56064 0
+61 3 9076 3451
Fax 56064 0
+61 3 9076 2298
Email 56064 0
aspencer@netspace.net.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary