A multicenter, phase II study of bortezomib and dexamethasone as induction treatment followed by high dose melphalan (HDM) and autologous stem cell transplantation (SCT) in patients with de novo amyloid light chain (AL) amyloidosis
- Conditions
- AL amyloidosis10035227
- Registration Number
- NL-OMON39975
- Lead Sponsor
- HOVO
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
* Biopsy proven, systemic, untreated AL amyloidosis requiring systemic chemotherapy,
* Age 18 -70 years inclusive at the time of signing the informed consent form,
* Measurable plasma cell dyscrasia, defined as a detectable M-protein with serum electrophoresis and/or level of involved FLC> 50 mg/L,
* Life expectancy > 3 months,
* WHO performance status 0-2,
* NYHA stage 1-2,
* Negative pregnancy test at inclusion for women of childbearing potential,
* Written informed consent.
* Multiple Myeloma stage II and III (Durie and Salmon),
* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form,
* Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule,
* Previous treatment for plasma cell dyscrasia
* Pregnant or breast feeding females.
* Presence of other active malignancy or a history of active malignancy during the past 5 years, with the exception of nonmelanoma skin cancer, stage 0 cervical carcinoma, or treated early-stage prostate cancer provided that prostate-specific antigen is within normal limits,
* Hypersensitivity to boron or mannitol,
* Uncontrolled infection,
* Symptomatic othostatic hypotension defined as a decrease in systolic blood pressure on standing of >20mmHg combined with symptoms like dizziness, cerebral and/or cardial ischemia,
*NT pro BNP level > 5000 pg/ml and Troponin T> 0.06 microgram/l (not high senstitivity assay) or NT proBNP level > 5000 pg/ml and Troponin I > 2 times ULN
* Symptomatic effusions, defined as pleural effusion or ascites needing drainage therapy,
* Positive for HIV or infectious hepatitis, B or C,
* Bilirubin > 2x upper limit of normal,
* Creatinin clearance < 30 ml/min (after rehydration),
* Absolute neutrophil count < 1.0 × 109/L,
* NCI CTCAE grade peripheral sensory neuropathy > grade 2,
* NCI CTCAE grade peripheral sensory neuropathy > grade 1 in the presence of neuropathic pain,
*NCI CTCAE grade peripheral motor neuropathy > grade 2
* Concurrent diagnosis of B-cel NHL or B-CLL,
* Previous organ transplantation.
* Unwilling or unable to use adequate contraception
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* Hematological CR rate 6 months after auto-SCT. Patients are considered a<br /><br>success if they received HDM and auto-SCT and are in CHR at 6 months, all other<br /><br>patients are considered a failure. </p><br>
- Secondary Outcome Measures
Name Time Method