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UARK 2006-66, Total Therapy 3B: An Extension of UARK 2003-33 Total Therapy

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
University of Arkansas Identifier:
First received: December 11, 2007
Last updated: September 5, 2017
Last verified: September 2017
With this study - Total Therapy IIIB - researchers are extending the findings of Total Therapy III based what they have learned from the first two studies (Total Therapy I and II), with new research strategies designed to explore why chromosome abnormalities found in persons with multiple myeloma affect the outcome of drug therapy used in this disease."

Condition Intervention Phase
Multiple Myeloma Drug: Velcade Drug: Thalidomide Drug: Dexamethasone Drug: Adriamycin Drug: Cisplatin Drug: Cyclophosphamide Drug: Etoposide Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Incorporating Bone Marrow Microenvironment (ME) - Co-Targeting Bortezomib Into Tandem Melphalan-Based Autotransplants With DTPACE for Induction/Consolidation and Thalidomide + Dexamethasone for Maintenance

Resource links provided by NLM:

Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • To find out if outcomes of participants in this study will be better when compared to individuals who participated in Total Therapy II, especially those with chromosome abnormalities. [ Time Frame: 48 months ]

Secondary Outcome Measures:
  • To find out if outcomes and incidence of toxicities of participants in this study will be better when compared to individuals who participated in Total Therapy III. [ Time Frame: 48 months ]

Enrollment: 177
Study Start Date: November 2006
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VDTPACE
Velcade, Dexamethasone, Thalidomide, Cisplatinin, Adriamycin, Cyclophosphamide and Etoposide
Drug: Velcade
Will be given in central venous catheter
Other Name: Bortezomib, PS-341
Drug: Thalidomide
Capsule taken by mouth
Other Name: Thalomid
Drug: Dexamethasone
A pill taken by mouth
Other Name: Decadron, NSC-34521
Drug: Adriamycin
Given into the vein (IV) by a continuous infusion through a central catheter
Other Name: Doxorubicin, NSC-123127
Drug: Cisplatin
Given into the vein (IV) by a continuous infusion through a central catheter
Other Name: Cis-diamminedichloroplatinum [CDDP], Platinol, NSC-119875
Drug: Cyclophosphamide
Given into the vein (IV) by a continuous infusion through a central catheter
Other Name: Cytoxan, NSC-26271
Drug: Etoposide
Given into the vein (IV) by a continuous infusion through a central catheter
Other Name: VP-16), Vepesid®, Ethylidene-Lignan P., NSC-141540

Detailed Description:

It is well known that myeloma patients with chromosome abnormalities are at higher risk because their disease tends to be more aggressive and does not respond to treatment as well as patients without chromosome abnormalities. When researchers at the Myeloma Institute looked at the results of Total Therapy II, they found that although research subjects with chromosome abnormalities had better outcomes (how many responded, and how long they survived) than those treated with standard chemotherapy; still their outcomes did not improve significantly with Total Therapy II, when compared to Total Therapy I.

The research in this new study is designed to target this high-risk group of individuals with chromosomal abnormalities. However, it is hoped that both groups of research participants - those with and without chromosome abnormalities - will derive benefit from changes made in this new research study.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have newly diagnosed active MM 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 (quantifiable serum M-component of IgG, IgA, IgD, or IgE; urinary kappa or lambda light chain; or serum free light chain (SFLC) levels in order to evaluate response. Non-secretory patients are eligible provided the patient has > 20% plasmacytosis OR multiple (>3) focal plasmacytomas or focal lesions on MRI OR diffuse hyperintense signal on STIR images in the absence of hematopoietic growth factors.
  • Patients must have received no more than one cycle or one month of prior chemotherapy for this disease. Patients may have received prior radiotherapy provided approval has been obtained by the Principal Investigator.
  • Patients must be <75 years of age at the time of initial registration.
  • Ejection fraction by ECHO or MUGA ≥ 40% performed within 60 days prior to registration.
  • Patients must have adequate pulmonary function studies > 50% of predicted on mechanical aspects (FEV1, FVC, etc) and diffusion capacity (DLCO) > 50% of predicted, within 60 days of registration. If the patient is unable to complete pulmonary function tests due to MM related pain or condition, exception may be granted if the principal investigator documents that the patient is a candidate for high dose therapy.
  • 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.
  • All patients must be informed of the investigational nature of this study and must have signed an IRB-approved informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

  • Platelet count < 30 x 109/L, unless myeloma-related.
  • Grade > 2 peripheral neuropathy.
  • Hypersensitivity to bortezomib, boron, or mannitol.
  • Uncontrolled diabetes.
  • Recent (< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias.
  • Evidence of chronic obstructive or chronic restrictive pulmonary disease.
  • Patients must not have light chain deposition disease or creatinine > 3 mg/dl
  • Patients must not have prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has not received treatment for one year prior to enrollment. Other cancers will only be acceptable if the patient's life expectancy exceeds five years.
  • Patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection.
  • Pregnant or nursing women. Women of child-bearing potential must have a negative pregnancy test documented within one week of registration. Women and men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
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Please refer to this study by its identifier: NCT00572169

United States, Arkansas
University of Arkansas for Medical Sciences/Myeloma Institute
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Principal Investigator: Gareth Morgan, MD, PhD UAMS Myeloma Institute for Research and Therapy
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Arkansas Identifier: NCT00572169     History of Changes
Other Study ID Numbers: 72023
Study First Received: December 11, 2007
Last Updated: September 5, 2017

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Etoposide phosphate
Liposomal doxorubicin
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs processed this record on September 19, 2017