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TT II: Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy

Information source: University of Arkansas
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma

Intervention: Thalidomide (Drug); Ara-C (Drug); BCNU (Drug); Cisplatin (Drug); Cytoxan (Drug); Dexamethasone (Drug); Doxorubicin (Drug); Etoposide (Drug); Filgrastim (Drug); Recombinant GM-CSF (Drug); Interferon-alpha-2b (Drug); Melphalan (Drug); Vincristine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: University of Arkansas

Official(s) and/or principal investigator(s):
Bart Barlogie, M.D., Ph.D., Principal Investigator, Affiliation: UAMS

Summary

This study has been designed to evaluate whether "anti-angiogenesis" therapy with thalidomide and whether additional chemotherapy after transplant will be beneficial. Another objective is to find out what kinds of side effects occur with this combination of treatment and how often they occur.

Clinical Details

Official title: 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

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

Primary outcome: 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.

Secondary outcome: 1.1 Evaluate whether the addition of thalidomide during remission induction and with consolidation chemotherapy after two transplants and during maintenance can improve event free survival from 40 to 50% after 5 years.

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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 coordinators.

- 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 guidelines.

- 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.

Locations and Contacts

University of Arkansas for Medical Sciences/MIRT, Little Rock, Arkansas 72205, United States
Additional Information

Myeloma Institute for Research & Therapy website

Starting date: August 1998
Last updated: January 23, 2015

Page last updated: August 23, 2015

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