UARK 2003-33, Total Therapy III
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 10/19/2017 |
| Start Date: | January 2004 |
| End Date: | September 2014 |
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
There have been two previous Total Therapy studies for multiple myeloma (MM) at the Myeloma
Institute for Research and Therapy (MIRT): Total Therapy I (from 1989 through 1994) and Total
Therapy II (from 1996 to 2004). Results have shown that patients treated on these studies had
better outcomes (meaning patients have lived longer and had better responses to treatment)
when compared to patients treated with standard chemotherapy.
With this new study, Total Therapy III, researchers will take what they have learned from the
first two studies and add new treatment strategies to try to improve the outcomes even more,
especially for patients with chromosome abnormalities.
Institute for Research and Therapy (MIRT): Total Therapy I (from 1989 through 1994) and Total
Therapy II (from 1996 to 2004). Results have shown that patients treated on these studies had
better outcomes (meaning patients have lived longer and had better responses to treatment)
when compared to patients treated with standard chemotherapy.
With this new study, Total Therapy III, researchers will take what they have learned from the
first two studies and add new treatment strategies to try to improve the outcomes even more,
especially for patients with chromosome abnormalities.
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.
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.
We found this trial at
1
site
Click here to add this to my saved trials
