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UARK 98-026, Total Therapy II - A Phase III Study for Newly Diagnosed Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy

Phase 3
18 Years
75 Years
Open (Enrolling)
Multiple Myeloma

Thank you

Trial Information

UARK 98-026, Total Therapy II - A Phase III Study for Newly Diagnosed Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy

Treatment will be given in 4 phases or steps: Induction, Transplant 1 and 2, Consolidation,
and maintenance. Induction is designed to induce (or bring about) myeloma into remission.
Each patient enrolled on this study will be randomly assigned to receive the above treatment
alone or in combination with a drug called thalidomide. Some patients may be eligible to
receive the transplant as an outpatient, based on general health and other factors.After
recovery from the transplant phase of the study (approximately 6 weeks), patients originally
assigned to thalidomide will resume taking it and will continue taking it throughout the
rest of the study treatment. All patients will receive post-transplant consolidation
treatment, which in earlier studies has been found to be helpful in maintaining patients
response after transplant. Therefore, all patients will receive a combination of drugs
called "D PACE" which consists of Dexamethasone, Cis-Platinum, Adriamycin, Cyclophosphamide,
and Etoposide. If you are also taking thalidomide, you will continue taking it throughout,
and the treatment is called "DT PACE" to include the thalidomide. No sooner than 4 weeks,
and no later than 12 weeks after consolidation and if your myeloma remains in remission
after consolidation therapy is complete, you will begin the last phase of the study, which
is maintenance. Maintenance is designed to keep your myeloma in remission long-term.

Inclusion Criteria:

- Patients must have newly diagnosed active multiple myeloma requiring treatment.
Patients with a previous history of smoldering myeloma will be eligible if there is
evidence of progressive disease requiring chemotherapy.

- Protein criteria must be present in order to evaluate response.Non-secretory patients
are eligible provided the patient has > or = 20% plasmacytosis or multiple (>3) focal
plasmacytomas on MRI or diffuse hyperintense signal on STIR images in the absence of
hematopoietic growth factors is seen.

- All necessary baseline studies for determining stage, bloodwork, and bone marrow must
be obtained within 35 days prior to registration.

- Patients must have received no more than one cycle of prior chemotherapy including
one month of Dexamethasone and Thalidomide for this disease. Patients may have
received prior radiotherapy provided approval has been obtained by one of the study

- Patients must have a performance status of 0-2 based on SWOG criteria. Patients with
a poor performance status (3-4), based solely on bone pain, will be eligible.

- Patients with renal failure, even if on dialysis, are eligible if it is felt to be
due to myeloma and if the duration of renal failure does not exceed two months

- Patients must be 75 years of age or less at the time of registration

- All patients must be informed of the investigational nature of this study and must
sign and give written informed consent in accordance with institutional and federal

- If medically appropriate, patients with pathologic fractures, pneumonia at diagnosis
or hyperviscosity with shortness of breath should have these conditions attended to
prior to registration.

Exclusion Criteria:

- Patients must not have significant co-morbid medical conditions or uncontrolled life
threatening infection

- Patients must not have uncontrolled diabetes

- Patients with recent (< or =6 months) myocardial infarction, unstable angina,
difficult to control congestive heart failure, uncontrolled hypertension, or
difficult to control cardiac arrythmias are ineligible. Ejection fraction by ECHO or
MUGA should be within the institutional normal range and must be performed within 42
days prior to registration.

- Patients must not have a history of chronic obstructive or chronic restrictive
pulmonary disease.

- No prior malignancy is allowed except for adequately treated basal cell or squamous
cell skin cancer, in situ cervical cancer, or other cancer for which the patient has
been disease free for at least three years.Prior malignancy is acceptable provided
there has been no evidence of disease within the three-year interval and there must
be no prior treatment with cytotoxic drugs that could potentially be assigned on this
treatment protocol.

- Pregnant or nursing women may not participate. Women of child-bearing potential must
have a negative pregnancy documented within one week of registration. Women/men of
reproductive potential may not participate unless they have agreed to use two forms
of effective contraceptive method.

Type of Study:


Study Design:

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

Outcome Measure:

Determine the beneficial role of anti-angiogenesis therapy with thalidomide and to determine the role of dose consolidation during consolidation therapy following tandem autotransplants with melphalan 200 mg/m2.

Outcome Time Frame:

Overall event free survival time

Safety Issue:


Principal Investigator

Bart Barlogie, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:

UARK 98-026



Start Date:

August 1998

Completion Date:

December 2012

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Cancer
  • Therapy
  • Thalidomide
  • Transplant
  • VAD
  • DCEP
  • CAD
  • Consolidation
  • Melphalan
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



University of Arkansas for Medical Sciences/MIRT Little Rock, Arkansas  72205