Nutritional and Metabolic Diseases

All Conditions

Neoplasms

Immune System Diseases

Blood and Lymph Conditions

Rare Diseases

Amyloidosis

Immunoglobulin Light-chain Amyloidosis

Proteostasis Deficiencies

Metabolic Diseases

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Immunoproliferative Disorders

Paraproteinemias

AL Amyloidosis

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dexamethasone

Daratumumab

Pomalidomide

Dexamethasone acetate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

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

Daratumumab SC

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

Kathleen P Research Nurse Coordinator, RN

Michaela Liedtke, MD

Vaishali Sanchorawala, MD

Research Nurse Coordinator

Cara Rosenbaum, MD

Anita D'Souza, MD

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.

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

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

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.

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

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.

Median estimate calculated using the Kaplan-Meier methodology

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

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

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

Spots Global Cancer Trial Database for refractory al amyloidosis