Health TrialsbyHealthPanel

Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis

ConditionAL Amyloidosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorPeking University People's Hospital

About this trial

This study aims to evaluate the use of teclistamab in systemic AL amyloidosis and answer whether teclistamab can improve the rate of complete hematological response.

This is a single-arm, multi-center, prospective study. Participants will receive the single drug teclistamab, which the investigator deems the best choice.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of systemic AL amyloidosis;

Patients must have received standard-of-care daratumumab, bortezomib, they do not have at least one organ response, and have not get complete hematological response;

Life expectancy greater than 12 weeks;

HGB ≥70g/L;

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

  • Teclistamab (Tec)

    Drug

    Teclistamab is administered subcutaneously with higher step-up doses (SUDs). Patients receive teclistamab with SUDs: 0.2 and 0.7 mg/kg and 1.5 mg/kg in Cycle 1 (2-4 days between doses). 3 mg/kg every 4 weeks will be used in subsequent cycles.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Group 1Other 1 intervention

Trial outcomes

Primary outcomes

1

Complete hematological response

Complete hematological response using ISA criteria

Time frame
3 months, 6 months

Secondary outcomes

1

Minimal residual disease

Bone marrow minimal residual disease detected by multi-flow cytometry at the sensitivity of at least 10\^-5.

Time frame
3 months, 6 months
2

Stringent dFLC response

dFLC ≤ 10 mg/L

Time frame
3 months, 6 months
3

TRAE

Treatment realted adverse events

Time frame
3 months, 6 months, 12 months
4

MOD-PFS

The time from the beginning of treatment to death, clinical manifestation of end-stage cardiac or renal failure, or hematologic progression, whichever occurs first.

Time frame
12 months, 24 months

Other outcomes

Sponsors and contacts

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

Peking University People's Hospital

Lead sponsor

Peking University

Sponsor institution

Source ClinicalTrials.gov
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