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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Light Chain Deposition Disease (LCDD or MIDD), Light Chain and Heavy Chain Deposition Disease (LHCDD or MIDD), Monoclonal Immunoglobulin Deposition Disease (MIDD), Amyloidosis

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Trial Information

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


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consent may be withdrawn by the subject at any time without prejudice to future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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To examine the tolerability

Outcome Description:

of a 3-phase comprehensive treatment approach including induction with BD followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with MIDD and AL amyloidosis.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Hani Hassoun, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

11-061

NCT ID:

NCT01383759

Start Date:

June 2011

Completion Date:

June 2014

Related Keywords:

  • Light Chain Deposition Disease (LCDD or MIDD)
  • Light Chain and Heavy Chain Deposition Disease (LHCDD or MIDD)
  • Monoclonal Immunoglobulin Deposition Disease (MIDD)
  • Amyloidosis
  • BORTEZOMIB (VELCADE)
  • CYCLOPHOSPHAMIDE (CYTOXAN)
  • DEXAMETHASONE
  • MELPHALAN
  • 11-061
  • Amyloidosis
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021