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Tandem Autotransplantation for Multiple Myeloma Patients With Less Than 12 Months of Preceding Therapy, Incorporating Bortezomib With the Transplant Chemotherapy and During Maintenance

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

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Trial Information

Tandem Autotransplantation for Multiple Myeloma Patients With Less Than 12 Months of Preceding Therapy, Incorporating Bortezomib With the Transplant Chemotherapy and During Maintenance

This study is targeted towards patients who have been diagnosed with Multiple Myeloma and
have had no prior autologous or allogeneic transplant. Furthermore, only up to 12 months of
prior treatment are allowed in this patient population. The study schema consists of one
round of induction chemotherapy, two transplants, one round of consolidation chemotherapy,
and two years of maintenance treatment. This study design differs from its historical
predecessors in the following manner:

- In contrast to Total Therapy II and III, which only allow enrollment of patients with
at most one cycle or one month of treatment prior to enrollment, the proposed study
allows enrollment of patients with up to 12 months of prior treatment. No statistically
significant difference in outcome between patients with one or no cycle of preceding
therapy and those with up to 12 months of prior therapy. This should allow enrollment
of significantly more myeloma patients.

- Induction therapy has been reduced to a single cycle.

- Bortezomib and thalidomide have been added to the transplant regimen.

- BCNU is added to the second transplant to high dose melphalan.

- Gemcitabine is added to the second transplant regimen.

- Consolidation treatment has been reduced to a single cycle.

- The first year of maintenance is with bortezomib, thalidomide and dexamethasone, and
the second year of maintenance therapy consists of dexamethasone only.

- The novel agents thalidomide and bortezomib are not introduced upfront, but only with
transplantation and maintenance.

Inclusion Criteria:

1. Patients must have the diagnosis of active MM requiring treatment. Patients with a
previous history of smoldering myeloma will be eligible if there is evidence of
progressive disease requiring chemotherapy.

2. Protein criteria must be present (quantifiable M-component of IgG, IgA, IgD, or IgE
and/or urinary kappa or lambda light chain, Bence-Jones protein, or Free Kappa Light
Chain or Free Lambda Light Chain) in order to evaluate response. Non-secretory
patients are eligible provided the patient has > 20% plasmacytosis OR multiple (>3)
focal plasmacytomas or focal lesions on MRI.

3. Patients must have received no more than 12 months of prior chemotherapy for this
disease. Patients may have received prior radiotherapy provided approval has been
obtained by the Principal Investigator.

4. Patients must be 18-75 years of age at the time of initial registration.

5. Ejection fraction by ECHO or MUGA ≥ 40% performed within 60 days prior to

6. Patients must have adequate pulmonary function studies > 50% of predicted on
mechanical aspects (FEV1, FVC) and diffusion capacity (DLCO) > 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, exception may be granted if the
principal investigator documents that the patient is a candidate for high dose

7. Patients must have a creatinine < 3 mg/dl and a creatinine clearance >30mL/min

8. 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.

9. 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.

Exclusion Criteria:

1. Platelet count < 30 x 109/L, unless myeloma-related.

2. Greater than a grade 2 peripheral neuropathy.

3. Hypersensitivity to bortezomib, boron, or mannitol.

4. Uncontrolled diabetes.

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

6. Evidence of chronic obstructive or chronic restrictive pulmonary disease.

7. Patients must not have light chain deposition disease-related renal failure or
creatinine > 3 mg/dl.

8. 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.

9. Patients must not have significant co-morbid medical conditions or uncontrolled life
threatening infection.

10. 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:


Study Design:

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

Outcome Measure:

To determine whether, in comparison to TT II, the median EFS can be increased from 4.8 years to 6.2 years, which represents an increase in median EFS of approximately 30%

Outcome Time Frame:

After enrollment of 204 subjects is completed

Safety Issue:


Principal Investigator

Guido J Tricot, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Utah


United States: Institutional Review Board

Study ID:




Start Date:

February 2008

Completion Date:

August 2012

Related Keywords:

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