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Trial record 86 of 107 for:    "Vascular Hemostatic Disease" | "Doxorubicin"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00572169
Recruitment Status : Active, not recruiting
First Posted : December 12, 2007
Last Update Posted : September 19, 2018
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Myeloma Drug: Velcade Drug: Thalidomide Drug: Dexamethasone Drug: Adriamycin Drug: Cisplatin Drug: Cyclophosphamide Drug: Etoposide Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 177 participants
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
Study Start Date : November 2006
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00572169

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Arkansas Identifier: NCT00572169     History of Changes
Other Study ID Numbers: 72023
First Posted: December 12, 2007    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018

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