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Daratumumab for Patients With Light Chain Amyloidosis

ConditionLight Chain (AL) Amyloidosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNanjing University School of Medicine

About this trial

This is a prospective, single-center study exploratory clinical trial, aim to exploring the efficacy and safety of daratumumab in patients with AL amyloidosis, patients were divided into three groups: one group received long-term treatment with daratumumab based regimen, and the other group received autologous stem cell transplantation after two standard treatment courses with daratumumab based regimen, and the third group consists of newly diagnosed stage IIIb AL amyloidosis patients who plan to receive DPD treatment. The purpose of this study is to observe the efficacy and safety of Daratumumab, in the treatment of newly diagnosed systemic AL amyloidosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must be aged ≥18 and ≤75 years;

Newly diagnosed AL amyloidosis ((confirmed by pathological examination with at least one major organ involvement (heart, kidney, or liver));

In group A and B, according to the Mayo 2004 staging system, the disease is classified as stage Ⅰ-ⅢA; In group C, according to the Mayo 2004 staging system, the disease is classified as stage IIIB: NT⁃proBNP>8500ng/L and cTnT>0.035μg/L or cTnI>0.01g/L;

Participants must personally sign an informed consent form approved by the Ethics Committee before the start of the study;

Disqualifiers

eGFR< 30ml/min/1.73m2;

Combined multiple myeloma;

Acute or chronic infection requiring treatment within 30 days prior to baseline;

Pregnant or breastfeeding women.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dratumumab / Hyaluronidase Injection [Darzalex Faspro]

    Drug

    Daratumumab will be administered at the FDA-approved dose of 16mg/kg as an intravenous infusion.

  • Pomalidomide 4 MG

    Drug

    Patients received oral pomalidomide on days 1-21 of a 28-days cycle from cycle 1 to 6.

  • autologous stem cell transplantation (ASCT)

    Procedure/Surgery

    The ASCT protocol included mobilisation with colony-stimulating factor alone and conditioning with high-dose melphalan140-200 mg/m2 .

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: long-term daratumumab treatment group (group A)Active comparator 1 intervention
Group B: daratumumab combine with ASCT treatment group (group B)Experimental treatment 2 interventions
Group C: Daratumumab and Dexamethasone combined with pomalidomide (DPD) (group C)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Hematological complete response rate

the 6 months overall hematologic complete response rate after treatment.

Time frame
6 months
2

Organ response rate

the 1-year organ response rate after treatment

Time frame
1 year

Secondary outcomes

1

Time to Next Treatment

Number of months from study drug initiation to starting another treatment

Time frame
3 years
2

Progression-free survival

the 3 years progression-free survival after treatment

Time frame
3 years
3

Overall survival

the 5 years overall survival after treatment

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanjing University School of Medicine

Lead sponsor

Source ClinicalTrials.gov
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