Autologous stem cell transplantation for patients with amyloid light chain (AL) amyloidosis

Autologous stem cell transplantation for patients with AL amyloidosis. A prospective phase II study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN01207094

Enrollment

Registered

2010-11-11

Start date

2000-09-04

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyloid light-chain (AL) amyloidosis Nutritional, Metabolic, Endocrine Amyloidosis

Interventions

Patients will be undergo the following treatments: 1. VAD induction treatment (3-4 weeks) courses, consisting of vincristine, doxorubicin (Adriamycin®), dexamethasone 2. Stem cell mobilization with G-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18-65 years incl. 2. Monoclonal Gammopathy of Undetermined Significance (MGUS), multiple myeloma stage I 3. Histologically documented systemic AL amyloidosis 4. Untreated or previously treated with maximal 3 courses of melphalan and prednisone 5. The patient must give informed consent according to the rules of the hospital

Exclusion criteria

Exclusion criteria: 1. Prior malignancies diagnosed less than 5 years ago, except non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma 2. Patients with familial variants of systemic amyloidosis 3. Severe pulmonary, neurologic, psychiatric, cardiac, liver or metabolic disease not related to AL amyloidosis

Design outcomes

Primary

Measure	Time frame
1. Response (clonal and clinical) 2. Overall survival.	—

Secondary

Measure	Time frame
Percentage of patients that will ultimately receive an autologous transplant.	—

Countries

Belgium, Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026