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Phase III Randomized Trial of Thalidomide/Dexamethasone vs VAD as Induction Chemotherapy for Newly Diagnosed Myeloma Patients and Evaluation of the Effects of Zoledronate on Chemotherapy Induced Apoptosis and Antigen Presentation.


Phase 3
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

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Trial Information

Phase III Randomized Trial of Thalidomide/Dexamethasone vs VAD as Induction Chemotherapy for Newly Diagnosed Myeloma Patients and Evaluation of the Effects of Zoledronate on Chemotherapy Induced Apoptosis and Antigen Presentation.


If the patients are randomized to receive VAD they will have an intravenous catheter
inserted. The chemotherapy drugs, vincristine and adriamycin will be administered by
continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is
considered one "cycle" of therapy. The patients will receive 4 to 6 cycles of therapy. The
dexamethasone will be taken in a pill form. During the first 2 cycles it will be taken on
days 1-4, 9-12, and 17-20. For all other cycles dexamethasone will be taken only on days
1-4.

Patients who are randomized to receive thalidomide and dexamethasone will take thalidomide
orally once every day in the evening for 4 to 6 months. The dexamethasone will be taken in a
pill form. During the first 2 cycles it will be taken on days 1-4, 9-12, and 17-20. For all
other cycles dexamethasone will be taken orally on days 1-4.

The dose of thalidomide will start at 100 mg per day and will be increased slowly to 200 mg
over several weeks. All patients taking thalidomide will also be required to comply with
the System of Thalidomide Education and Prescribing Safety program (S.T.E.P.S.). This is a
program of education and safety related to the use of Thalidomide and the prevention of
pregnancy. You will be required to sign a separate consent indicating that they understand
and agree with the guidelines. Women of child bearing potential will be required to have a
negative pregnancy test within 24 hours of starting thalidomide. This will be repeated every
week for 4 weeks and then monthly for the duration of thalidomide therapy. Women with
irregular menstruation will have the pregnancy test done every 2 weeks.

All patients will receive zoledronate by intravenous infusion, over at least 15 minutes
monthly (either on the first or fifteenth day of each month). The schedule will be randomly
selected and the patient will not have a choice on which day you receive the zoledronate.

Supportive medications (all study patients):

During each cycle of therapy, additional medications will be given to help reduce the side
effects of treatment. Patients enrolled in this study will be prescribed supportive
medications such as: 1) stomach acid suppressors to prevent stomach ulcers, and 2)
antibiotics to protect against infections while receiving dexamethasone, 3) "blood thinners"
to reduce the development of blood clots. This medicine can be taken as pills or shots under
the skin.If the subject will receive VAD then they will be on a preventative dose of blood
thinner. If they are to receive thalidomide/dexamethasone you will be on a higher dose of
blood thinner. Other medications such as those used to prevent nausea, diarrhea and
medications for low blood counts may also be given as needed.

At the end of 4 months, those patients who are eligible, will proceed to have high-dose
chemotherapy and stem cell transplantation. These patients will then be taken off active
study.

Patients not eligible for transplant will continue with chemotherapy or thalidomide and
dexamethasone for 2 additional months (total of 6 months) and will then be taken off active
study.


Inclusion Criteria:



- Patients must have newly diagnosed MM confirmed by the presence of bone marrow
plasmacytosis with > 10 percent plasma cells, sheets of plasma cells, or
biopsy-proven plasmacytoma. Patients must have Durie-Salmon Stage IIA-B or IIIA-B.
Patients with non-secretory myeloma are eligible. (These patients will not be
included in the analysis of response rates, but will be assessed for toxicity and
survival).

- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2, or 3

- ≥ 18 years of age.

- Signed informed consent form

- Expected survival of greater than 8 weeks

- Capable of swallowing study medication tablets

- Capable of following directions regarding taking study medication, or has a daily
care provider who will be responsible for administering study medication.

- Patients will be eligible for study even if they lack socioeconomic access to
autologous transplantation. (These patients will be identified prior to
randomization so as not to confound study results).

- All patients (in the event that they are randomized to the thalidomide/dexamethasone
arm) must agree to take part in the "System for Education and Prescribing Safety"
(S.T.E.P.S.)™. They must sign a separate informed consent for this program.

Exclusion Criteria:

- Elevated direct bilirubin > 2 mg/dl

- Serum alanine aminotransferase ( ALT, formerly SGPT) or serum aspartate
aminotransferase (AST, formerly SGOT) > 2 times the upper limit of normal (ULN)

- Absolute neutrophil count (ANC) <1000/mL, unless felt to be secondary to myeloma

- Ongoing radiation therapy, or radiation therapy within 3 weeks prior to first
treatment, unless the acute side effects associated with such therapy are resolved.

- Prior treatment for multiple myeloma

- Prior bisphosphonate use is allowed but they must be discontinued before starting
treatment.

- Concurrent uncontrolled serious infection

- Patients with peripheral (sensory) neuropathy, grade 3 or higher

- Life-threatening illness (unrelated to tumor)

- History of any other ACTIVE and INVASIVE cancer other than the present condition
(except non-melanoma skin cancer), unless in complete remission and off of all
therapy for that disease for a minimum of 3 years.

- Women of childbearing potential (unless utilizing birth control) or who are pregnant
or nursing will be excluded from this study.

- Patients with comorbid conditions that would contraindicate the use of vincristine,
doxorubicin, dexamethasone, thalidomide, or zoledronate.

- Plasma Cell Leukemia

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Level of Response Observed

Outcome Description:

Compare response rates of thalidomide/Dexamethasone vs. VAD as induction regimens in newly diagnosed MM. The Blade (15) criteria for remission in multiple myeloma will be used to assess response to VAD and thalidomide/dexamethasone therapy. Any improvement that meets the criteria for complete response (CR), partial response (PR), or minimal response (MR) will be considered a response for the purposes of calculating the primary endpoint. Progressive disease (PD) or relapse from CR will be considered treatment failure in determining the primary endpoint.

Outcome Time Frame:

6 Months or until start of transplant for transplant candidates

Safety Issue:

No

Principal Investigator

Melissa Alsina, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Institutional Review Board

Study ID:

MCC-13043

NCT ID:

NCT00215943

Start Date:

June 2003

Completion Date:

August 2012

Related Keywords:

  • Multiple Myeloma
  • hematologic malignancy
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Morton Plant HospitalClearwater, Florida  33756
Watson ClinicLakeland, Florida  33805
H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612
Fawcett Memorial HospitalPort Charlotte, Florida  33952