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Phase II Trial for Patients Not Qualifying for TT4 and TT5 Protocols Because of Prior Therapy (No Prior Transplant)

Phase 2
18 Years
75 Years
Open (Enrolling)

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Trial Information

Phase II Trial for Patients Not Qualifying for TT4 and TT5 Protocols Because of Prior Therapy (No Prior Transplant)

- 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 myeloma

- 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-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. Bone marrow aspirates and biopsies are tissue sample
collected from the bone cavity.

Inclusion Criteria:

- Patients with symptomatic multiple myeloma (MM), with at least one prior line of

- Zebroid ≤ 2, unless solely due to symptoms of MM-related bone disease (Appendix 4).

- Patients must be at least 18 years of age and not older than 75 years of age at the
time of registration.

- Patient must not have had a prior auto- or allotransplant.

- Patient must have signed an IRB-approved informed consent and understand the
investigational nature of the study.

- 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 prior to enrollment. Patients unable to complete pulmonary function
tests because of myeloma-related chest pain, must have a high resolution CT scan of
the chest and must also have acceptable arterial blood gases defined as P02 greater
than 70.

- Ejection fraction by ECHO or MUGA must be > 40% and must be performed within 60 days
prior to enrollment, unless the patient has received chemotherapy within that period
of time (dexamethasone and thalidomide excluded), in which case the LVEF must be

- 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 be able to receive full doses of Mel-VRD-PACE, in the opinion of the
treating investigator, with the exception that patients with creatinine clearance
30-50 ml/min will receive only 50% of the cisplatin dose.

Exclusion Criteria:

- Fever or active infection requiring intravenous antibiotic, defined as fever or
antibiotics within 72 hours from registration.

- Severe renal dysfunction, defined as a creatinine > 3mg/dl or a creatinine clearance
of < 30ml/min.

- Significant neurotoxicity, defined as grade > 3 neurotoxicity per NCI Common Toxicity
Criteria (See Appendix).

- Platelet count < 30,000/mm3, and ANC < 1,000/μl

- POEMS Syndrome: (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy,
and Skin changes

- Clinically significant hepatic dysfunction as noted by direct bilirubin or AST >3
times the upper normal limit or clinically significant concurrent hepatitis.

- New York Heart Association (NYHA) Class III or Class IV heart failure (Appendix 4).

- Recent (< 6 months) myocardial infarction, unstable angina, difficult to control
congestive heart failure, uncontrolled hypertension, or difficult to control cardiac
arrhythmias are ineligible.

- Patients with a history of treatment for clinically significant ventricular cardiac

- 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.

- Prior cumulative total of Adriamycin exposure >450 mg/m2.

- Prior exposure to thalidomide which resulted in severe toxicity requiring drug

- Prior exposure to Revlimid which resulted in severe toxicity requiring drug

- Hypersensitivity to boron, or Mannitol. Prior exposure to bortezomib which resulted
in severe toxicity requiring drug discontinuation.

- Pregnant or nursing women may not participate. Women of childbearing potential must
have a negative pregnancy documented within one week of registration. Women/men of
reproductive potential may not participate unless they have agreed to use an
effective contraceptive method.

Type of Study:


Study Design:

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

Outcome Measure:

The primary objective of this study is to assess the continued complete and near complete response rate (CR/nCR) at two years after initiation of therapy. .

Outcome Time Frame:

Two years

Safety Issue:


Principal Investigator

Bart Barlogie, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arkansas


United States: Institutional Review Board

Study ID:

UARK 2008-03



Start Date:

March 2009

Completion Date:

March 2015

Related Keywords:

  • Myeloma
  • This study is being done in an attempt to improve the remission rate and the survival time for participants with high-risk myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



University of Arkansas for Medical Sciences Little Rock, Arkansas  72205