Health TrialsbyHealthPanel

Bortezomib, Pomalidomide, Dexamethasone for Systemic AL Amyloidosis

ConditionSystemic Amyloidosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-90
SponsorJin Lu, MD

About this trial

This is an open-label, multicenter, Phase 2 study in subjects with newly diagnosed or previous treated systemic light chain (AL) amyloidosis. Approximately 40 subjects will receive therapy with bortezomib, pomalidomide, and dexamethasone. The primary outcome is hematologic very good partial response and complete response rate at 6 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of AL amyloidosis, confirmed by histology and typed with immunohistochemistry, immunoelectron microscopy or mass spectrometry.

Newly diagnosed or previous treated AL amyloidosis

Patients must be ≥ 18 years of age.

ECOG performance status 0, 1 or 2.

Disqualifiers

Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.

Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;

Severe or persistent infection that cannot be effectively controlled;

Presence of severe autoimmune diseases or immunodeficiency disease;

Trial design

Design model

Single group

Treatments tested in this trial

  • Bortezomib

    Drug

    Bortezomib 1.3mg/m2 sc weekly

  • Pomalidomide

    Drug

    4mg per day taken orally on 1-21 of repeated 28-day cycles

  • Dexamethasone

    Drug

    Dexamethasone 20mg-40mg weekly

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: BPdExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Hematologic VGPR + CR rate at 6 months

Hematologic very good partial response plus complete response rate at 6 months

Time frame
6 months

Secondary outcomes

1

Overall Hematologic response rate at 6 months

Overall Hematologic partial response, very good partial response rate and complete response at 6 months

Time frame
6 months
2

At least one organ response at 6 months

At least one organ response (cardiac response, renal response, liver response) at 6 months

Time frame
6 months
3

TTNT at 2 years

Time to next treatment at 2 years

Time frame
2 years
4

Estimated PFS at 2 years

Estimated Progression free survival at 2 years

Time frame
2 years

Other outcomes

Sponsors and contacts

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

Jin Lu, MD

Lead sponsor

Peking University People's Hospital

Sponsor institution

Source ClinicalTrials.gov
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