Age > or = to 18
New diagnosis of MIDD or AL amyloidosis based on pathologic findings confirmed at
Memorial Sloan Kettering Cancer Center.
Patients must show the ability to understand the investigational nature of the
treatment and to give voluntary informed consent before performance of any
study-related procedure not part of normal medical care, with the understanding that
consent may be withdrawn by the subject at any time without prejudice to future
Female subject is either postmenopausal for at least 1 year before the screening
visit, is surgically sterilized or if they are of childbearing potential, agree to
practice 2 effective methods of contraception from the time of signing the informed
consent form through 30 days after the last dose of bortezomib, or agree to
completely abstain from heterosexual intercourse.
Male subjects, even if surgically sterilized (i.e., status post-vasectomy) must agree
to 1 of the following: practice effective barrier contraception during the entire
study treatment period and through a minimum of 30 days after the last dose of study
drug, or completely abstain from heterosexual intercourse.
Adequate organ function defined as follows: Absolute granulocytes > 1,000/mm3 and
platelets > 70,000/mm3, unless low granulocyte and platelets counts are due to
multiple myeloma; total bilirubin < 1.5 ULN; AST, ALT, and alkaline phosphatase < 3
times upper limit of laboratory normal; LVEF > 50% by MUGA or ECHO (the method used
at baseline must be used for later monitoring); DLCO > 50 % confirmed at MSKCC;
elevated creatinine is not a contraindication to enrollment
Performance status (ECOG) < or = to 2
Patient has received other investigational drugs with 14 days before enrollment
Prior initial treatment chemotherapy for MIDD, AL amyloidosis or multiple myeloma
with the exception of one cycle of high dose dexamethasone
Prior bortezomib treatment
Myocardial infarction within 6 months prior to enrollment or New York Heart
Association Class III or IV heart failure (see Appendix 20.2), uncontrolled angina,
severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of
acute ischemia or active conduction system abnormalities. Prior to study entry, any
ECG abnormality at screening has to be documented by the investigator as not
Pregnant or lactating women are ineligible. A pregnancy test will be performed on
each fertile premenopausal female 2 weeks prior to entry into the study. Treatment
may not begin until the results of the pregnancy test are ascertained. All patients
(men and women) must agree to use medically approved contraceptive measures for at
least 4 weeks before starting therapy, during therapy, and for at least 3 months
after therapy has stopped.
Pre existing neuropathy, sensory or neuropathic pain findings, grade 2 or higher on
the NCI CTC neurotoxicity scale.
Concurrent active malignancy other than non melanoma skin cancers or carcinoma in
situ of the cervix. Patients with previous malignancies, but which have not required
anti tumor treatment within the preceding 24 months will be allowed to enter the
trial. Patients with a history of a T1a or b prostate cancer (detected incidentally
at TURP and comprising less than 5% of resected tissue) may participate if the PSA
has remained within normal limits since TURP.
Patients with known HIV positivity or AIDS related illness. This is based upon the
possibility of increasing HIV viral load with therapy
Any other medical condition or reason that, in the principal investigator's opinion,
makes the patient unsuitable to participate in a clinical trial
Patients with a history of hypersensitivity reactions attributed to bortezomib,
boron, or mannitol.
Radiation therapy within 3 weeks before randomization. Enrollment of subjects who
require concurrent radiotherapy (which must be localized in its field size) should be
deferred until the radiotherapy is completed and 3 weeks have elapsed since the last
date of therapy.