Status:
COMPLETED
Tandem Transplantation in Multiple Myeloma (MM) Patients With <12 Months of Prior Treatment
Lead Sponsor:
Guido Tricot
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The two objectives of this study are: * To increase the 2-year event-free survival from 55%, established with Total Therapy II (UARK 98-026), to 75% in myeloma patients with cytogenetic abnormalities...
Detailed Description
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 ar...
Eligibility Criteria
Inclusion
- 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.
- 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.
- 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.
- Patients must be 18-75 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 \> 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 therapy.
- Patients must have a creatinine \< 3 mg/dl and a creatinine clearance \>30mL/min
- 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.
Exclusion
- Platelet count \< 30 x 109/L, unless myeloma-related.
- Greater than a grade 2 peripheral neuropathy.
- Hypersensitivity to bortezomib, boron, or mannitol.
- Uncontrolled diabetes.
- Recent (\< 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.
- Patients must not have light chain deposition disease-related renal failure or creatinine \> 3 mg/dl.
- 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 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00670631
Start Date
February 1 2008
End Date
April 1 2014
Last Update
August 31 2017
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