Clinical trial · Interventional
HD Melphalan and SCT in Patients With IGDD or LCDD
High-Dose Melphalan and Autologous Stem Cell Transplantation (HDM/SCT) in Light-Chain Deposition Disease (LCDD) and Immunoglobulin Deposition Disease (IGDD)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor accrual
Summary
Brief summary (as posted)
RATIONALE: Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. PURPOSE: This phase II trial is studying the side effects of high-dose melphalan given together with stem cell transplant and to see how well it works in treating patients with immunoglobulin deposition disease or light-chain deposition disease.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| filgrastim | Biological | Filgrastim | ALIAS |
| melphalan | Drug | Melphalan | ALIAS |
| Stem Cell Infusion | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SCT with melphalan conditioning
- description
- Mobilization with Filgrastim Stem Cell Transplant Melphalan Conditioning Stem Cell infusion
- interventionNames
- Biological: filgrastim
- Drug: melphalan
- Procedure: Stem Cell Infusion
Primary outcomes (1)
- measure
- Hematologic Response Rate
- timeFrame
- one year
Secondary outcomes (4)
- measure
- Predictability of Early Free Light-chain Response for Heme Response
- timeFrame
- One month
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed light-chain deposition disease based on the following criteria:
* Deposition of granular material containing free light-chain (FLC) immunoglobulins that did not bind Congo red
* Evidence of a plasma cell dyscrasia, as defined by any of the following:
* Monoclonal gammopathy in the serum or urine by immunofixation electrophoresis
* Clonal plasmacytosis on bone marrow biopsy by immuno-histochemical
* Elevated serum levels of FLC
* Patients may enroll after stem cell collection (SCC) if all prestudy requirements are completed prior to starting SCC (i.e., ≥ 2.5 x 10\^6 cells available for transplantation)
PRIOR CONCURRENT THERAPY:
* Prior chemotherapy with alkylating agent allowed provided there is no evidence of myelodysplastic syndromes
* Prior total dose of melphalan \< 300 mg
* More than 4 weeks since prior cytotoxic therapy and recovered
PATIENT CHARACTERISTICS:
* Performance status 0-2
* Left Ventricular Ejection Fraction (LVEF) ≥ 45% within the past 90 days
* diffusing capacity of lung for carbon monoxide (DLCO) ≥ 50%
Exclusion Criteria:
* No overt multiple myeloma, as defined by any of the following:
* Greater than 30% bone marrow plasmacytosis
* Extensive (i.e., \> 2) lytic lesions
* Hypercalcemia
* No myocardial infarction, congestive heart failure, or arrhythmia refractory to therapy within the past 6 months
* No prior malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, adequately treated stage I or II cancer from which the patient is currently in complete response, or any other cancer from which the patient has been disease-free for the past 5 years
* No HIV positivityReferences
Publications (0)
Data not yet available