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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT04270175
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • AL Amyloidosis
  • Amyloid
  • Refractory AL Amyloidosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab SC — DRUG
    Given as 1800mg via injection
  • Pomalidomide — DRUG
    Given as 4mg oral capsule
  • Dexamethasone — DRUG
    Given as 20mg or 40 mg IV and 20mg or 40mg oral tablet.

Study Details

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.

Key Dates

Start date
Apr 14, 2021
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: daratumumab/pomalidomide/dexamethasone
    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

Primary Outcome Measure

Percentage of Participants With Overall Complete Hematologic Response [ Time Frame: Follow-up for up to 1 year ]

Locations (4)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304-
Boston University Medical CenterBostonMassachusetts02118-
Weill Cornell Medicine - Multiple Myeloma CenterNew YorkNew York10065-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Palo Alto, CA

By research site
Stanford University· Palo Alto, CABoston University Medical Center· Boston, MAWeill Cornell Medicine - Multiple Myeloma Center· New York, NYMedical College of Wisconsin· Milwaukee, WI

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