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Phase II Study of Pegylated Liposomal Doxorubicin (Doxil®), Low Frequency Dexamethasone and Revlimid® (Dd-R) in Newly Diagnosed Multiple Myeloma


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

Phase II Study of Pegylated Liposomal Doxorubicin (Doxil®), Low Frequency Dexamethasone and Revlimid® (Dd-R) in Newly Diagnosed Multiple Myeloma


Induction Phase:

Newly diagnosed multiple myeloma patients with active disease 20, will be treated with Dd-R
as outlined below:

All patients will also receive Levaquin 500 mg by mouth (PO) every day (QD)(or if allergic
receive amoxicillin 250 mg PO twice a day [BID]), acyclovir 400 mg PO BID or Valacyclovir
500mg BID and aspirin 81 mg PO QD daily while receiving Dd-R. Aspirin will continue through
maintenance. For patients who cannot tolerate aspirin, low molecular weight heparin or
therapeutic doses of coumadin may be used in place of aspirin.

- Doxil® 30mg/m2 on day # 1 to be repeated every 28 days

- Dexamethasone 40mg per day for 4 days (days 1-4) every 28 days

- Revlimid® 25mg po daily on days 1-21, followed by 7 days of no therapy, repeated every
28 days.

Maintenance Therapy:

Patients who complete the induction regimen or those who complete at least 2 cycles of the
induction regimen and not showing evidence of progressive disease but cannot tolerate any
further chemotherapy could be started on maintenance therapy as follows:

- Revlimid® 15mg or 25mg* po daily on days 1-21, followed by 7 days of no therapy,
repeated every 28 days.

- Dexamethasone 40mg per day for 4 days (days 1-4) every 28 days

All participants will also receive aspirin 81 mg PO QD daily while receiving maintenance.
For patients who cannot tolerate aspirin, low molecular weight heparin or therapeutic doses
of coumadin may be used in place of aspirin.


Inclusion Criteria:



- Signed informed consent form

- Able to adhere to the study visit schedule and other protocol requirements

- Diagnosed with active multiple myeloma and be considered to have active disease

- Measurable myeloma paraprotein levels in serum (≥ 0.5 g/dL) or urine (≥ 0.2 g
excreted in a 24-hour urine collection sample).

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2

- Performance status of 3 will be allowed if related to bony disease.

- Prior steroid therapy for up to 4 weeks will not exclude the patient from entering
the study.

- Bilirubin < 3.0

- Liver enzymes: alanine transaminase or aspartate transaminase (ALT or AST) < 3 x
upper limit of normal (ULN)

- Must have adequate bone marrow function:

- Absolute neutrophil count > 1,000 cells/mm³ (1.0 x 10^9/L). Patients with bone marrow
>50% plasma cells are permitted to have a neutrophil count of < 1,000 cells/mm³.

- Platelets ≥ 50,000 cells/mm³. Patients with bone marrow >50% plasma cells are
permitted to have a Platelet count < 50, 000 cells/mm³.

- Hemoglobin > 8 g/dL (transfusion allowed to increase the Hgb)

- Must have adequate renal function: Creatinine ≤ 2.5 mg/dL

- Must have a 2-d echocardiogram indicating left ventricular ejection fraction (LVEF) ≥
50% within 42 days prior to first dose of study drug

- Able to tolerate aspirin, low molecular weight heparin or coumadin

- Must be registered into the mandatory RevAssist® program, and be willing and able to
comply with the requirements of RevAssist®

- Females of childbearing potential (FCBP) must have a negative serum or urine
pregnancy test with a sensitivity of at least 50 mIU/mL within 10 to 14 days prior to
and again within 24 hours of prescribing lenalidomide (prescriptions must be filled
within 7 days) and must either commit to continued abstinence from heterosexual
intercourse or begin TWO acceptable methods of birth control AT THE SAME TIME, at
least 4 weeks before taking lenalidomide. FCBP must also agree to ongoing pregnancy
testing. Men must agree to use a latex condom during sexual contact with a female of
child bearing potential even if they have had a successful vasectomy.

Exclusion Criteria:

- Ongoing severe infection requiring intravenous antibiotic treatment

- Life expectancy of <3 months

- Prior malignancy, except for adequately treated basal cell or squamous cell skin
cancer, in-situ cervical cancer, or other cancer from which the subject has been
disease-free for at least 5 years. Concurrent prostate cancer for which the patient
is receiving therapy will not be considered an exclusion if the prostatic specific
antigen (PSA) has been stable for three years.

- Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma
cell dyscrasia.

- Patients receiving therapeutic dosages of steroids (dexamethasone 160mg per pulse > 4
pulses) for multiple myeloma.

- Myocardial infarct within 6 months before enrollment, New York Heart Association
(NYHA) Class II or greater heart failure, uncontrolled angina, severe uncontrolled
ventricular arrhythmias, clinically significant pericardial disease, or
electrocardiographic evidence of acute ischemic or active conduction system
abnormalities.

- Uncontrolled medical problems such as diabetes mellitus, coronary artery disease,
hypertension, unstable angina, arrhythmias), pulmonary, hepatic and renal diseases
unless renal insufficiency is felt to be secondary to multiple myeloma.

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

- Pregnant or breast feeding females

- 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

- Prior chemotherapy for multiple myeloma, except for radiation to symptomatic bony
disease, plasmapheresis for hyperviscosity, kyphoplasty and/or vertebroplasty

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Participants With Overall Response (OR)

Outcome Description:

Overall response rate to induction Dd-R as assessed using International Myeloma Working Group Response Definitions

Outcome Time Frame:

24 Months

Safety Issue:

No

Principal Investigator

Rachid Baz, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Institutional Review Board

Study ID:

MCC-14986

NCT ID:

NCT00617591

Start Date:

January 2008

Completion Date:

April 2013

Related Keywords:

  • Multiple Myeloma
  • Lenalidomide
  • Revlimid
  • Pegylated Liposomal Doxorubicin
  • Doxil
  • Dexamethasone
  • Decadron
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612