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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00482261




Registration number
NCT00482261
Ethics application status
Date submitted
3/06/2007
Date registered
5/06/2007
Date last updated
10/01/2013

Titles & IDs
Public title
A Study of Low Dose Lenalidomide and Dexamethasone in Relapsed/Refractory Myeloma in Patients at High Risk for Myelosuppression
Scientific title
Phase II Trial of Low Dose Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma (Rev-Lite) in Patients at High Risk for Myelosuppression
Secondary ID [1] 0 0
07/04
Secondary ID [2] 0 0
RV-PI-0103
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lenalidomide
Treatment: Drugs - dexamethasone
Treatment: Drugs - aspirin

Experimental: len-dex - Drug: Lenalidomide 15mg daily, days 1-21 of a 28 day cycle for 4 cycles. Patients who get stable disease or better will then receive 15mg on days 1-21 from cycle 5 onwards; Drug: dexamethasone 20mg day 1-4, 9-12, 17-20 for 4 cycles. Patients who get stable disease or better will then get dexamethasone 20mg on days 1-4 of a 28 day cycle, from cycle 5 onwards


Treatment: Drugs: Lenalidomide
15mg daily, days 1-21 of a 28 day cycle for 4 cycles. Patients who get stable disease or better will then receive 15mg on days 1-21 from cycle 5 onwards

Treatment: Drugs: dexamethasone
20mg day 1-4, 9-12, 17-20 for 4 cycles. Patients who get stable disease or better will then get dexamethasone 20mg on days 1-4 of a 28 day cycle, from cycle 5 onwards

Treatment: Drugs: aspirin
100mg/day

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall response rate
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Time To Progression
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Duration of Response
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Safety and toxicity
Timepoint [4] 0 0
continuous
Secondary outcome [5] 0 0
Prognostic factors associated with ORR, TTP, OS
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Compare OTT, TTP an toxicities to MM-009/MM-010 data
Timepoint [6] 0 0
2 years

Eligibility
Key inclusion criteria
1. Understand and voluntarily sign consent form.

2. Must meet one of following age group requirements at the time of signing consent form.

1. age 18-59 years

2. >59 years

3. Patients 18-59 years are eligible only if:

- platelets between 50-74x109/L or

- calculated GFR between 20ml/min and 59ml/min

4. Able to adhere to the study visit schedule and other protocol requirements.

5. Subject was previously diagnosed with multiple myeloma based on standard diagnostic
criteria.

6. Must have relapsed or refractory disease.

7. Measurable disease, defined as follows:

- For secretory multiple myeloma: measurable disease is defined as any quantifiable
serum monoclonal protein value (generally, but not necessarily, >5g/L of
M-Protein). If the M band is <5g/L, then the serum free light chains(SFLC) must
be assessed and if >100mg/L will also be used to measure disease response. Where
applicable, urine light-chain excretion of =200 mg/24 hours will also be used to
measure disease response.

- For light chain disease (M band in serum <5g/L but measurable FLC in urine):
measurable disease is defined by either urine FLC OR the presence of serum FLC
(must be >100mg/L). Investigators can use either test (or both) but must use the
same method throughout the trial.

- For non-secretory multiple myeloma (no M-protein in serum or urine by
immunofixation): measurable disease is defined by soft tissue (not bone)
plasmacytomas as determined by clinical examination or applicable radiographs
(i.e. MRI, CT-Scan).

8. Patient has a life-expectancy =3 months.

9. All previous cancer therapy, including radiation, hormonal therapy and surgery, must
have been discontinued at least 4 weeks prior to treatment in this study.

10. ECOG performance status of =2 at study entry

11. Laboratory test results within these ranges:

- Absolute neutrophil count ³ 1.0 x 109/L (can be supported with growth factor)

- Total bilirubin =1.5 mg/dL

- AST (SGOT) or ALT (SGPT) =2 x UL

12. For females subjects:

- Must have two negative pregnancy tests (sensitivity = 50 mIU/mL) prior to
starting study drug. The first pregnancy test must be performed within 10-14 days
prior to the start of study drug and the second pregnancy test must be performed
within 24 hours prior to the start of study drug.

- Females of childbearing potential (FCBP)† must agree to use two reliable forms of
contraception simultaneously or to practice complete abstinence from heterosexual
intercourse during the following time periods related to this study: 1) for at
least 28 days before starting study drug; 2) while participating in the study;
and 3) for at least 28 days after discontinuation from the study.

13. Male Subjects:

- Must agree to use a latex condom during sexual contact with females of
childbearing potential while participating in the study and for at least 28 days
following discontinuation from the study even if he has undergone a successful
vasectomy.

- Will be warned that sharing study drug is prohibited and will be counseled about
pregnancy precautions and potential risks of fetal exposure.

14. Disease free of prior malignancies for =3 years with exception of currently treated
basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix
or breast.

15. Able to take aspirin daily as prophylactic anticoagulation. (patients intolerant to
ASA may use low molecular weight heparin).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Dexamethasone resistant myeloma based on last therapy. Patients are defined as being
refractory to high-dose dexamethasone if they achieved less than a partial response,
or developed progressive disease within 6 months of discontinuing dexamethasone, or
dexamethasone was discontinued because of =Grade 3 dexamethasone-related toxicity.
High-dose dexamethasone therapy is defined as >500mg dexamethasone or equivalent over
a 10-week period, whether administered alone or as part of the VAD regimen.

2. Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form.

3. Pregnant or breast feeding females. (Lactating females must agree not to breast feed
while taking lenalidomide).

4. 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.

5. Use of any other experimental drug or therapy within 28 days of baseline.

6. Known hypersensitivity to thalidomide.

7. The development of erythema nodosum if characterized by a desquamating rash while
taking thalidomide or similar drugs.

8. Any prior use of lenalidomide.

9. Concurrent use of other anti-cancer agents or treatments.

10. Known positive for HIV or infectious hepatitis, type A, B or C.

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
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] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3002 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Peter MacCallum Cancer Centre, Australia
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Celgene Corporation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to see whether combination of low dose lenalidomide(10mg)+
dexamethasone is equally effective in treating relapsed/refractory myeloma in the group of
elderly patients and other patients at risk of myelosuppression, whilst producing less side
effects, especially myelosuppression compared to the higher dose of lenalidomide of 25mg used
in the MM-009 and MM-010 trials.
Trial website
https://clinicaltrials.gov/show/NCT00482261
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Miles H Prince, MD
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00482261