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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00572169
First received: December 11, 2007
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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: Bortezomib (Velcade)
Drug: Thalidomide
Drug: Dexamethasone
Drug: Melphalan
Drug: Cisplatin
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Etoposide
Drug: Filgrastim
Drug: Lenalidomide
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

Enrollment: 177
Study Start Date: November 2006
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VDTPACE
VDTPACE Cycle 1 with Gene Array pre/post VEL. Drug administration dependent on different factors through study, i.e., stage, platelets, etc.
Drug: Bortezomib (Velcade)
Other Name: Velcade, PS-341
Drug: Thalidomide
Other Name: Thalomid
Drug: Dexamethasone
Other Name: Decadron, NSC-34521
Drug: Melphalan
Other Name: Alkeran, NSC-8806
Drug: Cisplatin
Other Name: Cis-diamminedichloroplatinum [CDDP], Platinol, NSC-119875
Drug: Doxorubicin
Other Name: Adriamycin, NSC-123127
Drug: Cyclophosphamide
Other Name: Cytoxan, NSC-26271
Drug: Etoposide
Other Name: VP-16), Vepesid®, Ethylidene-Lignan P., NSC-141540
Drug: Filgrastim
Other Name: G-CSF, r-metHuG-CSF, Neupogen, NSC 614629
Drug: Lenalidomide
Other Name: CC-5013, IMiD-3, Revlimid,

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  • 5.1.2.2 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572169

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

No publications provided by University of Arkansas

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00572169     History of Changes
Other Study ID Numbers: UARK 2006-66
Study First Received: December 11, 2007
Last Updated: February 10, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Thalidomide
Melphalan
Lenalidomide
Bortezomib
Dexamethasone
Cisplatin
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014