Back to resultsUARK 2008-02 A Trial for High-risk Myeloma Evaluating Accelerating and Sustaining Complete Remission
Primary Purpose
Multiple Myeloma
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Velcade
Melphalan
Thalidomide
Dexamethasone
Cisplatin
Adriamycin
Cyclophosphamide
Etoposide
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
- Patients must have newly diagnosed active MM requiring treatment. Patients with previous history of smoldering myeloma will be eligible if there is evidence of progressive disease requiring chemotherapy.
- Patients must be either untreated o have not had more than one cycle of systemic MM therapy, excluding bisphosphonates and localized radiation.
- Patients must have high-risk disease, as defined by any one of the following:
- GEP risk score of > or = 0.66 or
- LDH > or = 360 U/L Rule out hemolysis, infection an contact PI for clarification
- Zubrod < or = 2, unless solely due to symptoms of MM-related bone disease.
- Patients must have a platelet count of > or = 50,000/uL, 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 > or = 45%
- Patients must have adequate pulmonary function studies > or = 50% of predicted on mechanical aspects (FEV squared, FVC, etc) and diffusion capacity (DLCO) > or = 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 principle 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.
Sites / Locations
- University of Arkansas for Medical Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MEL--VTD-PACE
Arm Description
Melphalan, Velcade, Thalidomide, Dexamethasone, Cisplatin, Adriamycin, Cyclophosphamide and Etoposide
Outcomes
Primary Outcome Measures
Accelerate and sustain, at 2 years from starting therapy
Secondary Outcome Measures
48hrs after melphalan 10mg/m2, gene expression profiling (GEP) examinations of CD138-purified MM plasma cells (PC)and of bone marrow biopsy (BX)samples
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00869232
Brief Title
UARK 2008-02 A Trial for High-risk Myeloma Evaluating Accelerating and Sustaining Complete Remission
Official Title
UARK 2008-02, A Phase II Trial for High-risk Myeloma Evaluation Accelerating and Sustaining Complete Remission (AS-CR) by Applying Non-host-exhausting and Timely Dose-reduced MEL-80-VRD-PACE Tandem Transplants
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
There have been four previous Total Therapy (TT1 through IIIB) studies for multiple myeloma at the MIRT from 1989 to present. Results have shown that participants treated on these studies had better outcomes (meaning they have lived longer and had better responses to treatment) when compared to individuals treated with standard chemotherapy.
Past studies conducted at the MIRT and at other institutions have shown that participants with high-risk features by gene array studies tend to have shorter remissions (disappearance of signs and symptoms of myeloma) and do not survive as long as participants with low-risk myeloma. Researchers at MIRT think that one reason for this is that the myeloma cells re-grow in the time when participants are not receiving treatment because they are recovering from high-dose chemotherapy. In this study, participants will receive several chemotherapy drugs previously shown to be effective in myeloma, but in lower doses and in shorter cycles. It is hoped that by giving the drugs in this way, myeloma cells will not have time to re-grow between cycles, therefore resulting in longer remissions. This study is being done in an attempt to improve the remission rate and the survival time for participants with high-risk myeloma.
Detailed Description
To find out if giving multi-agent chemotherapy in lower and more frequent doses to make the timely delivery of chemotherapy cycles possible, will result in better treatment outcomes
To find out if changing the way the drugs are given during the transplant phase will also result in fewer side effects, while still being effective
To find out if giving treatment between transplants (called "inter-transplant therapy") will prevent the myeloma from re-growing between transplants
To find out if long-term maintenance therapy will result in longer remissions
To find out what the effects (good and bad) of this overall treatment will be
To learn more about the biology and genetics of multiple myeloma by performing imaging tests and collecting blood, bone marrow aspirate and biopsies, and biopsies of lesions seen on MRI or PET scans for research
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MEL--VTD-PACE
Arm Type
Experimental
Arm Description
Melphalan, Velcade, Thalidomide, Dexamethasone, Cisplatin, Adriamycin, Cyclophosphamide and Etoposide
Intervention Type
Drug
Intervention Name(s)
Velcade
Other Intervention Name(s)
PS-341
Intervention Description
1.0mg/m2 days 1, 5, 8, & 11
Intervention Type
Drug
Intervention Name(s)
Melphalan
Other Intervention Name(s)
Alkeran
Intervention Description
10 mg/m2 day 3
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Other Intervention Name(s)
Thalomid
Intervention Description
200 mg days 5-8
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decadron
Intervention Description
40 mg day 5-8
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Platinol
Intervention Description
10 mg/m2 day 5-8
Intervention Type
Drug
Intervention Name(s)
Adriamycin
Other Intervention Name(s)
Doxorubicin
Intervention Description
10 mg/m2 day 5-8
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Cytoxan
Intervention Description
400 mg/m2 day 5-8
Intervention Type
Drug
Intervention Name(s)
Etoposide
Other Intervention Name(s)
Vp-16, Vepesid
Intervention Description
40 mg/m2 day 5-8
Primary Outcome Measure Information:
Title
Accelerate and sustain, at 2 years from starting therapy
Time Frame
2 years
Secondary Outcome Measure Information:
Title
48hrs after melphalan 10mg/m2, gene expression profiling (GEP) examinations of CD138-purified MM plasma cells (PC)and of bone marrow biopsy (BX)samples
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have newly diagnosed active MM requiring treatment. Patients with previous history of smoldering myeloma will be eligible if there is evidence of progressive disease requiring chemotherapy.
Patients must be either untreated o have not had more than one cycle of systemic MM therapy, excluding bisphosphonates and localized radiation.
Patients must have high-risk disease, as defined by any one of the following:
GEP risk score of > or = 0.66 or
LDH > or = 360 U/L Rule out hemolysis, infection an contact PI for clarification
Zubrod < or = 2, unless solely due to symptoms of MM-related bone disease.
Patients must have a platelet count of > or = 50,000/uL, 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 > or = 45%
Patients must have adequate pulmonary function studies > or = 50% of predicted on mechanical aspects (FEV squared, FVC, etc) and diffusion capacity (DLCO) > or = 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 principle 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frits van Rhee, MD, PhD
Organizational Affiliation
UAMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33357481
Citation
Pawlyn C. High-risk myeloma: a challenge to define and to determine the optimal treatment. Lancet Haematol. 2021 Jan;8(1):e4-e6. doi: 10.1016/S2352-3026(20)30361-6. Epub 2020 Dec 22. No abstract available.
Results Reference
derived
PubMed Identifier
29567784
Citation
Davies FE, Rosenthal A, Rasche L, Petty NM, McDonald JE, Ntambi JA, Steward DM, Panozzo SB, van Rhee F, Zangari M, Schinke CD, Thanendrarajan S, Walker B, Weinhold N, Barlogie B, Hoering A, Morgan GJ. Treatment to suppression of focal lesions on positron emission tomography-computed tomography is a therapeutic goal in newly diagnosed multiple myeloma. Haematologica. 2018 Jun;103(6):1047-1053. doi: 10.3324/haematol.2017.177139. Epub 2018 Mar 22.
Results Reference
derived
Links:
URL
http://myeloma.uams.edu/
Description
Multiple Myeloma
Learn more about this trial
UARK 2008-02 A Trial for High-risk Myeloma Evaluating Accelerating and Sustaining Complete Remission
We'll reach out to this number within 24 hrs