NCT04270175

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
20mo left

Started Apr 2021

Longer than P75 for phase_2

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Apr 2021Jan 2028

First Submitted

Initial submission to the registry

February 12, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

April 14, 2021

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

5.7 years

First QC Date

February 12, 2020

Last Update Submit

February 25, 2026

Conditions

AmyloidAL AmyloidosisRefractory AL Amyloidosis

Outcome Measures

Primary Outcomes (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

    Follow-up for up to 1 year

Secondary Outcomes (8)

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

    Follow-up for up to 5 years

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

    Follow-up for up to 1 year

  • Percentage of participants with an Organ Response

    Follow-up for up to 3 years

  • Median estimate of months that participants have Progression Free Survival

    Follow-up for up to 5 years

  • Median number of months of participant's Overall Survival

    Follow-up for up to 5 years

  • +3 more secondary outcomes

Study Arms (1)

daratumumab/pomalidomide/dexamethasone

EXPERIMENTAL

Pomalidomide: (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

Drug: Daratumumab SCDrug: PomalidomideDrug: Dexamethasone

Interventions

Daratumumab SCDRUG

Given as 1800mg via injection

Also known as: Faspro
daratumumab/pomalidomide/dexamethasone
PomalidomideDRUG

Given as 4mg oral capsule

daratumumab/pomalidomide/dexamethasone
DexamethasoneDRUG

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

daratumumab/pomalidomide/dexamethasone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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)

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Stanford University

Palo Alto, California, 94304, United States

Location

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Weill Cornell Medicine - Multiple Myeloma Center

New York, New York, 10065, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

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

    PMID: 40226119DERIVED

MeSH Terms

Conditions

Alzheimer DiseaseImmunoglobulin Light-chain Amyloidosis

Interventions

pomalidomideDexamethasone

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersNeoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesParaproteinemias

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • mateo Mejia Saldarriaga, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2020

First Posted

February 17, 2020

Study Start

April 14, 2021

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(4)