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AmyloidPhase 2NCT04270175

Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Patients Previously Exposed to Daratumumab

A Phase 2 study testing Daratumumab SC, Pomalidomide and Dexamethasone in people with Amyloid and AL Amyloidosis, run by Weill Medical College of Cornell University at 4 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study will test the hypothesis that in patients with previous daratumumab exposure, combination therapy of daratumumab, pomalidomide, and dexamethasone (DPd) will yield higher complete remission (CR) rates in relapsed/refractory amyloidosis than historical pomalidomide/dexamethasone treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Amyloid, AL Amyloidosis, Refractory AL Amyloidosis
What is being tested?
Daratumumab SC, Pomalidomide and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
4 sitesUnited States
Study dates
14 Apr 2021to Jan 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Diagnosis of primary AL amyloidosis of tissue
  • Relapsed and/or refractory AL amyloidosis
  • Has received daratumumab or Faspro in any prior line of therapy
  • Prior pomalidomide exposure allowed if ≥ PR achieved and no disease progression occurred within 60 days of last dose received
  • Measurable disease
  • Able to give voluntary written consent
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  • Eastern Cooperative Oncology Group performance status and/or other performance status 0, 1, or 2.
  • Absolute neutrophil count (ANC) ≥ 1,000/mm3 and platelet count ≥ 75,000/mm3.
  • Total bilirubin ≤ 1.5 × the upper limit of the normal range (ULN) (Total bilirubin ≥ 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN.
  • eGFR ≥ 20 mL/min/1.73 m2 (as calculated by Modified Diet in Renal Disease (MDRD) formula)

Who cannot join

  • Non-AL amyloidosis
  • Clinically overt myeloma
  • Prior exposure to non-daratumumab anti-CD38 monoclonal antibodies.
  • Clinically significant cardiac disease
  • Severe obstructive airway disease
  • Female patients who are lactating or have a positive serum pregnancy test during the screening period
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  • Planned high-dose chemotherapy and autologous stem cell transplantation within 6, 28-day treatment cycles after starting on treatment.
  • Failure to have fully recovered (ie, ≤ Grade 1 toxicity) from the reversible effects of prior chemotherapy.
  • Major surgery within 14 days before enrollment.
  • Radiotherapy within 14 days before enrollment.
  • Infection requiring systemic intravenous antibiotic therapy or other serious infection within 14 days before study enrollment. Systemic treatment, within 14 days before the first dose, with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital, see Appendix 11.7), or use of Ginkgo biloba or St. John's wort.
  • Positive for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C
  • Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Boston University Medical Center

    Boston, Massachusetts, 02118

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Weill Cornell Medicine - Multiple Myeloma Center

    New York, New York, 10065

  • Stanford University

    Palo Alto, California, 94304

Other trials in United States

About this study

This study will test the hypothesis that in patients with previous daratumumab exposure, combination therapy of daratumumab, pomalidomide, and dexamethasone (DPd) will yield higher complete remission (CR) rates in relapsed/refractory amyloidosis than historical pomalidomide/dexamethasone treatment.

Being tested
Daratumumab SC, Pomalidomide, Dexamethasone
Medical subject headings
Alzheimer Disease, Immunoglobulin Light-chain Amyloidosis

What participants receive

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

  • Daratumumab SCDrug

    Also called Faspro

    Given as 1800mg via injection

  • PomalidomideDrug

    Given as 4mg oral capsule

  • DexamethasoneDrug

    Given as 20mg or 40 mg IV and 20mg or 40mg oral tablet.

Study groups in NCT04270175
Study groupRoleWhat they receive
daratumumab/pomalidomide/dexamethasoneExperimentalPomalidomide: (4mg orally) on days 1-21 of a 28-day cycle Dexamethasone: * 20mg IV as premedication on days 1, 8, 15, and 22 * 20mg orally the day after daratumumab dosing for cycles 1-2 of induction * 40mg IV as premedication on days 1 and 15 on daratumumab treatment days * 40mg orally on non-daratumumab days (8 and 15) for cycles 3-6 * 20mg on day 1 of every cycle as premedication on daratumumab dosing day 1 in maintenance cycles (cycles 7 and beyond) * If you are a subject age 70 and older, the dexamethasone dosing will be reduced by 50% at the time of induction. Daratumumab: * 1800mg sub-cutaneously weekly x8 weeks * 1800mg sub-cutaneously every 2 weeks during induction (cycles 3-6) * 1800mg sub-cutaneously every 4 weeks cycles 7 and beyond
Receives: Drug: Daratumumab SC; Drug: Pomalidomide; Drug: Dexamethasone

What is being measured

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

  1. Percentage of Participants With Overall Complete Hematologic Response

    Overall complete hematologic response rate will be defined as percentage of participants who achieve Complete Hematologic Response

    Measured: Follow-up for up to 1 year

Secondary outcomes (8)

  1. Duration of Very Good Partial Response (VGPR) or better hematologic response rates

    Duration of hematologic VGPR or better response is defined as the time between the date of initial documentation of hematologic VGPR or better response to the date of first documented evidence of hematologic progressive disease.

    Measured: Follow-up for up to 5 years

  2. Low-dFLC Partial Response Rate (applicable to low-dFLC pt group)

    Percentage of participants who achieve a low-dFLC partial hematologic response rate and met criteria at screening for low-dFLC response assessment

    Measured: Follow-up for up to 1 year

  3. Percentage of participants with an Organ Response

    Organ response rate (OrRR) for kidney and cardiac is defined as the proportion of baseline organ involved participants who achieve organ response in each corresponding organ. Organ response defined for cardiac: N-terminal brain pronatriuretic peptide (NT-proBNP) response (> 30% and > 300 nanogram per liter [ng/L] decrease in participants with baseline NT-proBNP >= 650 ng/L) or New York Heart Association (NYHA) class response (>= 2 class decrease in participants with baseline NYHA class 3 or 4); for kidney: decrease in proteinuria by >=30% or below 0.5 grams /24 hours without renal progression.

    Measured: Follow-up for up to 3 years

  4. Median estimate of months that participants have Progression Free Survival

    Median estimate calculated using the Kaplan-Meier methodology

    Measured: Follow-up for up to 5 years

  5. Median number of months of participant's Overall Survival

    Overall survival (OS) is measured from the date of enrollment to the date of the participant's death

    Measured: Follow-up for up to 5 years

  6. Time to Complete Hematologic Response

    Measured in months between the date of enrollment and the first efficacy evaluation at which the participant has met the criteria for hematologic complete response.

    Measured: Follow-up for up to 1 year

  7. Time to Hematologic Progression

    Measured in months between the date of enrollment and the first efficacy evaluation at which the participant has met the criteria for hematologic progression

    Measured: Follow-up for up to 5 years

  8. Time until Next Treatment Therapy

    Measured in months from the date of enrollment to the start date of subsequent treatment for AL amyloidosis

    Measured: Follow-up for up to 5 years

Timeline

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

  1. First posted17 Feb 2020
  2. Study start14 Apr 2021
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2028 (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
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04270175
Sponsor's protocol ID
19-12021159
Status last verified
Feb 2026
First submitted
12 Feb 2020
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Locke M, Nieto M. AL Amyloidosis: Current Treatment and Outcomes. Adv Hematol. 2025 Mar 3;2025:7280805. doi: 10.1155/ah/7280805. eCollection 2025.

    PubMed 40226119

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Daratumumab SC, Pomalidomide and Dexamethasone in people with Amyloid and AL Amyloidosis, run by Weill Medical College of Cornell University at 4 sites in United States.

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 11 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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?

This study is still under way. Results are not available in the source record yet.

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?

Percentage of Participants With Overall Complete Hematologic Response (time frame: Follow-up for up to 1 year). 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 NCT04270175, which also lists 1 linked publication.

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 27 Feb 2026.

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