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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up follow-up for up to 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have been treated with daratumumab or Faspro before.
Select...
I can take care of myself and perform daily activities.
Select...
My AL amyloidosis has returned or is not responding to treatment.
Select...
I have been diagnosed with AL amyloidosis.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants With Overall Complete Hematologic Response
Secondary outcome measures
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 moreTrial 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
Pomalidomide
2011
Completed Phase 2
~1020
Dexamethasone
2007
Completed Phase 4
~2590
Find a Location
Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,055 Previous Clinical Trials
1,316,274 Total Patients Enrolled
Janssen Scientific Affairs, LLCIndustry Sponsor
159 Previous Clinical Trials
580,497 Total Patients Enrolled
Cara Rosenbaum, MDPrincipal InvestigatorWeill Medical College of Cornell University
2 Previous Clinical Trials
40 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition is active multiple myeloma.You have HIV, hepatitis B, or hepatitis C.I haven't needed IV antibiotics for an infection in the last 14 days.You need to have a certain level of white blood cells and platelets in your blood.I have been treated with anti-CD38 drugs that are not daratumumab.I am scheduled for high-dose chemotherapy and stem cell transplant within 6 months of starting treatment.I haven't had any cancer besides nonmelanoma skin cancer or in situ carcinoma, or if I have, it was treated over 2 years ago with no remaining signs.I took pomalidomide, improved, and didn't worsen within 60 days after the last dose.Your kidney function, as measured by eGFR, needs to be at least 20 mL per minute per 1.73 square meters.Your total bilirubin level should be within a certain range, and if it's higher than that range, your direct bilirubin level should be lower than a specific number.I have not had major surgery in the last 14 days.Your ALT and AST levels in the blood should be less than 3 times the upper limit of normal.I haven't taken strong medication or certain herbal supplements in the last 14 days.I have been treated with daratumumab or Faspro before.I have mostly recovered from side effects of my last chemotherapy.My condition is not light-chain (AL) amyloidosis.I have a serious heart condition.I am not pregnant or breastfeeding.I have severe breathing problems due to blocked airways.I can take care of myself and perform daily activities.You have a disease that can be measured.My AL amyloidosis has returned or is not responding to treatment.I have not had radiotherapy in the last 14 days.I have been diagnosed with AL amyloidosis.
Research Study Groups:
This trial has the following groups:- Group 1: daratumumab/pomalidomide/dexamethasone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial actively seeking participants?
"Yes, the clinicaltrials.gov website states that this medical trial is currently accepting participants. It was originally posted on April 14th 2021 and has undergone its most recent edit on June 8th 2022. For now, 21 patients are being sought out across 4 locations."
Answered by AI
Could you elucidate other recent trials that have researched Daratumumab?
"In 2002, Daratumumab was first examined by Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. Since then, 1158 trials have been concluded and 620 are currently recruiting patients in various states including Massachusetts with a focus on Boston."
Answered by AI
Are there any adverse effects of treatment with Daratumumab?
"The safety of Daratumumab has been judged a 2 on our Power organization's risk scale, as there is data presently available to support its security but none that suggests it can be effective."
Answered by AI
How many healthcare facilities are taking part in this trial?
"Currently, enrolment is taking place at 4 medical centres located in Boston, New york and Milwaukee. We advise potential participants to select the closest site available with a view to reduce their travel requirements."
Answered by AI
For what applications is Daratumumab primarily prescribed?
"Daratumumab is regularly used to manage ophthalmia and sympathetic, yet also has applications in treating branch retinal vein occlusion, macular edema, as well as communicable illnesses."
Answered by AI
How many participants can take part in this clinical research?
"Affirmative. The clinicaltrials.gov listing for this trial confirms that it is currently seeking participants; the posting was first made on April 14th 2021 and last updated June 8th 2022, with a total of 21 patients needed across 4 different sites."
Answered by AI
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