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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

Phase 2
18 Years
75 Years
Open (Enrolling by invite only)
Multiple Myeloma

Thank you

Trial Information

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

- 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

- 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

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Accelerate and sustain, at 2 years from starting therapy

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Saad Usmani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:



United States: Institutional Review Board

Study ID:

UARK 2008-02



Start Date:

October 2008

Completion Date:

October 2013

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



University of Arkansas for Medical Sciences Little Rock, Arkansas  72205