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Amyloidosis; SystemicPhase 2NCT04474938

Daratumumab Combined With Bortezomib and Dexamethasone in Mayo 04 Stage III Light Chain Amyloidosis

A Phase 2 study testing Daratumumab, Bortezomib and Dexamethasone in people with Amyloidosis; Systemic, run by Peking Union Medical College Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Patients with light chain (AL) amyloidosis who have advanced cardiac damage are at risk of premature mortality. There is ongoing unmet need for effective therapies to rapidly induce deep hematologic response and decrease the early death rate. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Amyloidosis; Systemic
What is being tested?
Daratumumab, Bortezomib and Dexamethasone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
24 May 2021to Mar 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years old adults.
  • Biopsy proved treatment-naïve AL amyloidosis.
  • Mayo 2004 stage III.
  • dFLC > 50mg/L.
  • Patient must provide informed consent.

Who cannot join

  • Co-morbidity of uncontrolled infection.
  • Co-morbidity of other active malignancy.
  • Co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia.
  • Co-morbidity of grade 2 or 3 atrioventricular block.
  • Co-morbidity of sustained or recurrent nonsustained ventricular tachycardia.
  • Seropositive for human immunodeficiency virus.
Show all 11Show fewer
  • Seropositive for hepatitis B (positive test for HBsAg). Participants with resolved infection (ie, HBsAg negative but positive for anti-HBc and/or anti-HBs) must be screened of HBV-DNA. Those who are PCR positive will be excluded.
  • Seropositive for hepatitis C (except in the setting of a sustained virologic response).
  • Grade 2 or higher neuropathy according to National Cancer Institute Common Terminology Criteria for Adverse Events.
  • Neutrophil <1×10E9/L，hemoglobin < 7g/dL，or platelet < 75×10E9/L.
  • Severely compromised hepatic or renal function: ALT or AST > 2.5 × ULN, total bilirubin > 1.5mg/dL，or eGFR < 40mL/min (those with renal dysfunction due to renal involvement or renal hypoperfusion from cardiac amyloidosis could be included)

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking Union Medical College Hospital

    Beijing, 100730

Other trials in China

About this study

Official title: Efficacy of Daratumumab Combined With Bortezomib and Dexamethasone in Patients With Mayo 04 Stage III Light Chain Amyloidosis: a Prospective Phase II Clinical Trial

Patients with light chain (AL) amyloidosis who have advanced cardiac damage are at risk of premature mortality. There is ongoing unmet need for effective therapies to rapidly induce deep hematologic response and decrease the early death rate. Lately, trials of daratumumab in newly-diagnosed and relapsed/refractory AL amyloidosis have shown dramatic response rates. However, the benefits of upfront daratumumab in stage III AL patients, especially stage IIIb patients, have not yet been demonstrated definitely in prospective studies. Therefore, we designed a phase II, single arm clinical trial to investigate the efficacy and safety of co-administration of daratumumab with bortezomib and dexamethasone (BD) regimen in treatment-naïve patients with Mayo 04 stage III AL amyloidosis. We planned to enroll 40 patients, who would receive daratumumab and BD treatment for a total duration of 12 months. The primary endpoint is complete response and very good partial response at 3 months after treatment initiation. Secondary endpoints include overall survival, organ response and adverse events.

Keywords
light chain amyloidosis, daratumumab, bortezomib, hematologic response, prognosis
Medical subject headings
Immunoglobulin Light-chain Amyloidosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DaratumumabDrug

    16mg/kg, QW Cycles 1-2 (28 days/cycle), Q2W Cycles 3-6, and Q4W thereafter for up to 1 year

  • BortezomibDrug

    1.3mg/m2 of subcutaneous bortezomib on days 1, 8, 15 and 22 of a 28-day cycle for 6 cycles

  • DexamethasoneDrug

    20mg of dexamethasone on days 1, 8, 15 and 22 of a 28-day cycle for 6 cycles

Study groups in NCT04474938
Study groupRoleWhat they receive
Dara-BDExperimentalDaratumumab combined with bortezomib and dexamethasone
Receives: Drug: Daratumumab; Drug: Bortezomib; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hematologic very good partial response or better at 3 months after treatment initiation

    Very good partial response or better is defined as complete response or very good partial response. Complete response: normalization of free light chain levels and ratio with negative serum and urine immunofixation electrophoresis. Very good partial response: difference between involved and uninvolved free light chains (dFLC) less than 40 mg/L

    Measured: 3 months

Secondary outcomes (18)

  1. Overall survival

    Measured: 2 years

  2. major organ deterioration progression-free survival

    Measured: 2 years

  3. Time to next treatment

    Measured: 2 years

  4. Mortality within 1 month from treatment initiation

    Measured: 1 month

  5. Mortality within 3 months from treatment initiation

    Measured: 3 months

  6. Mortality within 6 months from treatment initiation

    Measured: 6 months

  7. Hematologic very good partial response or better at 1 month after treatment initiation

    Measured: 1 month

  8. Hematologic very good partial response or better at 6 months after treatment initiation

    Measured: 6 months

  9. Hematologic very good partial response or better at 12 months after treatment initiation

    Measured: 12 months

  10. Stringent dFLC response

    dFLC declined to less than 10 mg/L

    Measured: 1 year

  11. Time to hematologic response

    Measured: 1 year

  12. Organ response at 3 months after treatment initiation

    Measured: 3 months

  13. Organ response at 6 months after treatment initiation

    Measured: 6 months

  14. Organ response at 12 months after treatment initiation

    Measured: 12 months

  15. Time to cardiac response

    Measured: 1 year

  16. Time to liver response

    Measured: 1 year

  17. Time to renal response

    Measured: 1 year

  18. Adverse events

    Adverse events are collected until 30 days after last dose of treatment

    Measured: treatment initiation to 30 days after last dose of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2020
  2. Study start24 May 2021
  3. Primary completionJun 2023 (estimated)
  4. Study completionMar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04474938
Sponsor's protocol ID
PUMCH-AL2020
Status last verified
May 2022
First submitted
14 Jul 2020
Last updated
10 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Daratumumab, Bortezomib and Dexamethasone in people with Amyloidosis; Systemic, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hematologic very good partial response or better at 3 months after treatment initiation (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04474938.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.

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