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Monoclonal Antibodies

DPd for Amyloidosis

Phase 2

Recruiting

Led By Cara Rosenbaum, MD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has received daratumumab or Faspro in any prior line of therapy

Eastern Cooperative Oncology Group performance status and/or other performance status 0, 1, or 2

Must not have

Clinically overt myeloma

Prior exposure to non-daratumumab anti-CD38 monoclonal antibodies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up follow-up for up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the efficacy of daratumumab+pomalidomide+dexamethasone (DPd) to pomalidomide+dexamethasone (Pd) in patients with relapsed or refractory amyloidosis.

Who is the study for?

This trial is for patients with relapsed/refractory light chain amyloidosis who have previously been treated with daratumumab. They should be relatively healthy (performance status 0-2), have normal liver function, stable kidney function, and acceptable blood counts. Patients must not have non-AL amyloidosis, serious infections, significant heart disease, or recent major surgery.

What is being tested?

The study is testing a combination therapy of Daratumumab SC (subcutaneous injection), Pomalidomide, and Dexamethasone in patients who've had Daratumumab before. It aims to see if this combo increases complete remission rates compared to previous treatments with pomalidomide/dexamethasone alone.

What are the potential side effects?

Possible side effects include immune system reactions like infusion-related responses from Daratumumab SC; fatigue and increased risk of infection from Dexamethasone; and potential blood clots or nerve damage from Pomalidomide.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been treated with daratumumab or Faspro before.

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I can take care of myself and perform daily activities.

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My AL amyloidosis has returned or is not responding to treatment.

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I have been diagnosed with AL amyloidosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My condition is active multiple myeloma.

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I have been treated with anti-CD38 drugs that are not daratumumab.

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I am scheduled for high-dose chemotherapy and stem cell transplant within 6 months of starting treatment.

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I have not had major surgery in the last 14 days.

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I haven't taken strong medication or certain herbal supplements in the last 14 days.

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I have mostly recovered from side effects of my last chemotherapy.

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My condition is not light-chain (AL) amyloidosis.

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I have a serious heart condition.

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I am not pregnant or breastfeeding.

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I have severe breathing problems due to blocked airways.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ follow-up for up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~follow-up for up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and follow-up for up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants With Overall Complete Hematologic Response

Secondary study objectives

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

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

Median estimate of months that participants have Progression Free Survival

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: daratumumab/pomalidomide/dexamethasoneExperimental Treatment3 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Daratumumab SC

2014

Completed Phase 3

~710

Pomalidomide

2011

Completed Phase 2

~1020