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UARK 2012-02 Trial For High-Risk Myeloma Evaluating Accelerating and Sustaining Complete Remission

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by University of Arkansas
Sponsor:
Collaborator:
Onyx Pharmaceuticals
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT02128230
First received: April 29, 2014
Last updated: October 6, 2016
Last verified: October 2016
  Purpose
The purpose of this study is to improve the clinical outcomes of research subjects with high-risk multiple myeloma in the context of the immediately preceding Total therapy 5 trial 2008-02 and Total therapy 3 trials 2003-33 and 2006-66.

Condition Intervention Phase
Multiple Myeloma
Drug: MEL-CFZ-TD-PACE
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase II Trial For High-Risk Myeloma Evaluating Accelerating and Sustaining Complete Remission (AS-CR) by Applying Non-Host -Exhausting and Timely Dose-Reduced Mel-80-CFZ-TD-Pace Transplant(s) With Interspersed Mel-20-CFZ-TD-Pace With CFZ-RD and CFZ-D Maintenance

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • The remission rate for participants with high-risk myeloma [ Time Frame: 132 months ]

Estimated Enrollment: 45
Study Start Date: August 2014
Estimated Study Completion Date: May 2025
Estimated Primary Completion Date: May 2025 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Treatment Drug: MEL-CFZ-TD-PACE
Melphalan and Carfilzomib will be given into a central venous catheter. Dexamethasone is a pill that is taken by mouth daily for 4 days. Thalidomide is a capsule taken by mouth for 4 days. Cisplatin, Adriamycin, Cyclophosphamide and Etoposide are all given into the vein (IV) by a continuous infusion through a central catheter for 4 days. After completion of the four days of continuous chemotherapy, a drug G-CSF will be given. This is a shot just under the skin to help the bone marrow and blood counts recover more quickly after chemotherapy.
Other Names:
  • Melphalan
  • Carfilzomib-CFZ
  • Thalidomide
  • Dexamethasone
  • Cisplatin
  • Adriamycin
  • Cyclophosphamide
  • Etoposide
  • G-CSF

Detailed Description:

Total therapy 5B will attempt to accelerate and sustain, at 2 years from starting therapy, the proportion of subjects in complete remission by reducing host-imposed toxicity and facilitating timely completion of highly synergistic 8-drug combination therapy, including the next generation proteasome inhibitor, Carfilzomib. This will result in avoiding multiple myeloma re-growth that, we postulate, ensued in Total therapy 3 during recovery phases from severe de-conditioning. It is speculated that the incidence of positive minimal residual disease will be reduced with the addition of one cycle of consolidation therapy. The following approach will be implemented:

  • apply a 4-day fractionated lower dose melphalan (80 mg/m2) together with CFZ-TD-PACE regimen in MEL80-CFZ-TD (carfilzomib, thalidomide, dexamethasone) PACE as a hopefully less toxic and more effective transplant regimen
  • interspersed with 1 cycle of non-transplant supported MEL-20-CFZ-TD (carfilzomib, thalidomide, dexamethasone) PACE (in lower doses than with transplant) inter-therapy (reduced from two cycles due to prolonged thrombocytopenia)
  • followed by CFZ-TD (carfilzomib, thalidomide, dexamethasone) PACE consolidation therapy post transplant #2
  • CFZ-RD (carfilzomib, lenalidomide and dexamethasone) maintenance for 1 year followed by CFZ-D for an additional year
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.
  • Patients must be either untreated or have not had more than one cycle of systemic MM therapy, excluding bisphosphonates and localized radiation.
  • Participants must have high-risk disease, as defined by GEP70 risk score of ≥ 0.66
  • Zubrod ≤ 2, unless solely due to symptoms of MM-related bone disease.
  • Patients must have a platelet count of ≥ 50,000/μL, unless lower levels are explained by extensive bone marrow plasmacytosis.
  • Patients must be at least 18 years of age and not older than 75 years of age at the time of registration.
  • Participants must have preserved renal function as defined by a serum creatinine level of < 3 mg/dL.
  • Participants must have an ejection fraction by ECHO or MUGA scan ≥ 45%
  • Patients must have adequate pulmonary function studies > 50% of predicted on mechanical aspects (FEV1, FVC, etc) and diffusion capacity (DLCO) > 50% of predicted. 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 signed an IRB-approved informed consent indicating their understanding of the proposed treatment and understanding that the protocol has been approved by the IRB.

Exclusion Criteria:

  • Does not have high-risk disease
  • Poorly controlled hypertension, diabetes mellitus, or other serious medical illness or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.
  • 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.
  • Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of registration. Subjects 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: NCT02128230

Contacts
Contact: Nathan M Petty 501-526-6990 ext 2435 pettynathanm@uams.edu
Contact: David Avery 501-526-6990 ext 2431 daavery@uams.edu

Locations
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Nathan M Petty    501-526-6990 ext 2435    pettynathanm@uams.edu   
Contact: Doug Steward    501-526-6990 ext 2452    dmsteward@uams.edu   
Sub-Investigator: Michele Fox, MD         
Sub-Investigator: Maurizio Zangari, MD         
Sub-Investigator: Atul Kothari, MD         
Sub-Investigator: Carolina Schinke, MD         
Sub-Investigator: Faith Davies, MD         
Sub-Investigator: Gareth Morgan, MD         
Sub-Investigator: Juan Crescencio, MD         
Sub-Investigator: Mary Burgess, MD         
Sub-Investigator: Meera Mohan, MD         
Sub-Investigator: Muthukumar Radhakrishnan, MD         
Sub-Investigator: Pankaj Mathur, MD         
Sub-Investigator: Sandra Susanibar-Adaniya, MD         
Sub-Investigator: Shadiqul Hoque, MD         
Sub-Investigator: Sharmilan Thanendrarajan, MD         
Sponsors and Collaborators
University of Arkansas
Onyx Pharmaceuticals
Investigators
Principal Investigator: Frits Van Rhee, MD, Ph.D University of Arkansas
  More Information

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT02128230     History of Changes
Other Study ID Numbers: 134668
Study First Received: April 29, 2014
Last Updated: October 6, 2016

Keywords provided by University of Arkansas:
High risk
Carfilzomib

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
Cisplatin
Dexamethasone
Cyclophosphamide
Etoposide
Thalidomide
Doxorubicin
Melphalan
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Antineoplastic Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 22, 2017