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Phase II Trial of Low Dose Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma (Rev-Lite) in Patients at High Risk for Myelosuppression

Phase 2
18 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

Phase II Trial of Low Dose Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma (Rev-Lite) in Patients at High Risk for Myelosuppression

Lenalidomide has proven efficacy in myeloma. In the Phase I studies with lenalidomide
monotherapy, responses were observed at doses of 5mg, 10mg and 25mg. The dose limiting
toxicity of lenalidomide monotherapy was myelosuppression·

In the International MM-010 and MM-009 studies, lenalidomide was administered at 25mg d1-d21
(with pulse dexamethasone) of a 28 day cycle. Although the overall response rate and time to
progression were impressive, a significant toxicity was myelosuppression. The average age in
these 2 studies was approximately 63 years, some 7 years lower than the median age for
myeloma. The median number of prior therapies was 2. Thus, if lenalidomide therapy is to be
optimally applied in an older and/or more heavily pre-treated population, a simpler, less
toxic regimen would be valuable. Low dose (15mg) lenalidomide (Rev-Lite) with dexamethasone
may achieve this goal·

Based on analysis of the MM009 and MM010 data the patients at highest risk for
myelosuppression and subsequent dose reduction were those over the age of 60 years (approx
30% risk which increased to approx 50% by 70 years).It is hypothesized that patients with
lower base-line platelets may also be at higher risk of lenalidomide-induced
myelosuppression. Little is known about lenalidomide tolerance in patients with impaired
renal function, consequently patients with relatively poorer renal function will also be
enrolled into this study.

Inclusion Criteria:

1. Understand and voluntarily sign consent form.

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

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

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

- 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).

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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Miles H Prince, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Peter MacCallum Cancer Centre, Australia


Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:




Start Date:

June 2007

Completion Date:

September 2013

Related Keywords:

  • Multiple Myeloma
  • myeloma
  • relapse
  • refractory
  • elderly
  • lenalidomide
  • Multiple Myeloma
  • Neoplasms, Plasma Cell