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NCT04612582
Comparison of BTD and BCD Based Regimens in the Treatment of AL Amyloidosis
Phase 4 trial testing Thalidomide in Immunoglobulin Light-Chain Amyloidosis in 70 participants. Status unknown.
31 January 2023
Quick facts
| Lead sponsor | Guangdong Provincial People's Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 70 |
| Start date | 1 January 2020 |
| Primary completion | 31 January 2023 |
| Estimated completion | 30 June 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- Thalidomide (THALIDOMIDE) — full drug profile →
- Cyclophosphamide (cyclophosphamide) — full drug profile →
Conditions studied
- Immunoglobulin Light-Chain Amyloidosis — all drugs for Immunoglobulin Light-Chain Amyloidosis →
Sponsor
Guangdong Provincial People's Hospital
Who can join
Adults 18 to 80, any sex, with Immunoglobulin Light-Chain Amyloidosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Research Objective:At present, there is no standard therapeutic regimen for monoclonal immunoglobulin light chain (AL) amyloidosis in the world. To compare the efficacy and safety of the regimens between bortezomib-thalidomide-dexamethasone (BTD) and bortezomib-cyclophosphamide-dexamethasone (BCD) in the treatment of AL amyloidosis, so as to provide more clinical evidence for the standard treatment for the disease. Research Design:This study was designed as a prospective, randomized and controlled clinical study. Patients who meet the inclusion criteria of this study will be randomized to the BTD scheme group or BCD scheme group.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04612582
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04612582 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Guangdong Provincial People's Hospital
- Last refreshed: 3 November 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04612582.
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