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A Phase 2 Study Incorporating Bone Marrow Microenvironment (ME) Co-Targeting Bortezomib Into Tandem Melphalan-Based Autotransplants With DT PACE for Induction/Consolidation and Thalidomide + Dexamethasone for Maintenance


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

A Phase 2 Study Incorporating Bone Marrow Microenvironment (ME) Co-Targeting Bortezomib Into Tandem Melphalan-Based Autotransplants With DT PACE for Induction/Consolidation and Thalidomide + Dexamethasone for Maintenance


1.1 To determine, in a historical comparison with TT II (Thalidomide arm), whether two
cycles of VDTPACE induction (instead of four induction cycles in TT II) followed by more
timely MEL 200-based transplant with DEX + THAL between transplants can:

1.1.1 Increase the CR frequency from 50% to 60% at 18 months from initiation of therapy;

1.1.2 Increase > n-CR rate pre-transplant #1 from 20% to 40%;

1.1.3 Raise 2-year EFS rates from 55% to 75% in patients with CA and from 80% to 95%, in
patients without CA.


Induction

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 M-component of IgG, IgA, IgD, or IgE
and/or urinary kappa or lambda light chain or Bence Jones protein) in order to
evaluate response. Non-secretory patients are eligible provided the patient has >
20% plasmacytosis or multiple (>3) focal plasmacytomas 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 of prior chemotherapy for this
disease. Patients may have received prior radiotherapy provided approval has been
obtained by the Principal Investigator.

- Patients must be < or = 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 > or = 50% of predicted on
mechanical aspects (FEV1, FVC, etc) and diffusion capacity (DLCO) > or =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, there must be a
pulmonary consult documenting 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.

Induction Exclusion Criteria:

- Platelet count < 30 x 10^9/L, unless myeloma-related

- ANC < 1.0 X 10^9/L, unless myeloma-related

- Grade > or =2 peripheral neuropathy

- Hypersensitivity to bortezomib, boron, or mannitol

- Uncontrolled diabetes.

- Recent (< or =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.

- 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 been
disease free for at least three 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

A historical comparison with TT II (Thalidomide arm), whether two cycles of VDTPACE induction (instead of four induction cycles in TT II) followed by more timely MEL 200-based transplant with DEX + THAL between transplants can:

Outcome Time Frame:

Participants/data will be followed and assessed for an expected average of 3 years

Safety Issue:

No

Principal Investigator

Bart Barlogie, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UAMS

Authority:

United States: Food and Drug Administration

Study ID:

UARK 2003-33

NCT ID:

NCT00081939

Start Date:

January 2004

Completion Date:

January 2014

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

University of Arkansas for Medical Sciences/MIRTLittle Rock, Arkansas  72205