Bortezomib/Dexamethasone (BD), Followed By Autologous Stem Cell Transplantation and Maintenance Bortezomib/Dexamethasone For the Initial Treatment of Monoclonal Immunoglobulin Deposition Disease (MIDD) Associated With Multiple Myeloma and AL Amyloidosis



Status:Active, not recruiting
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:5/13/2018
Start Date:June 24, 2011
End Date:June 2019

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Pilot Study of Bortezomib/Dexamethasone (BD), Followed By Autologous Stem Cell Transplantation and Maintenance Bortezomib/Dexamethasone For the Initial Treatment of Monoclonal Immunoglobulin Deposition Disease (MIDD) Associated With Multiple Myeloma and AL Amyloidosis

The goal of this clinical trial is to determine the toxicity and also the efficacy of a
treatment that includes the following treatment: Two medications, bortezomib and
dexamethasone (or BD), followed by autologous stem cell transplantation, and a prolonged
course of treatment with bortezomib and dexamethasone after transplantation. This type of
treatment has been very effective in multiple myeloma. However, there is little experience
with this treatment in patients who have Monoclonal Immunoglobulin Deposition Disease (MIDD)
or amyloidosis. The investigators and others have treated patients who have MIDD and
amyloidosis with bortezomib and autologous stem cell transplantation and have had success
with this treatment. But the combination of autologous transplant with BD given before and
after the transplant is a new way of treating these diseases, which the investigators believe
will be very effective.


Inclusion Criteria:

- 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consent may be withdrawn by the subject at any time without prejudice to future
medical care.

- 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

Exclusion Criteria:

- 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 medically
relevant.

- 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.
We found this trial at
6
sites
Basking Ridge, New Jersey 07920
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Commack, NY
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500 Westchester Avenue
Harrison, New York 10604
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Harrison, NY
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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1000 N Village Ave
Rockville Centre, New York 11570
(516) 256-3600
Memorial Sloan-Kettering at Mercy Medical Center Memorial Sloan Kettering Cancer Center Rockville Centre provides state-of-the-art...
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Rockville Centre, NY
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701 N Broadway
Sleepy Hollow, New York 10591
(914) 366-3000
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center Memorial Sloan Kettering Cancer Center Sleepy...
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Sleepy Hollow, NY
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