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Daratumumab, Ixazomib, Pomalidomide, and Dexamethasone as Salvage Therapy in Relapsed/Refractory Multiple Myeloma | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Daratumumab, Ixazomib, Pomalidomide, and Dexamethasone as Salvage Therapy in Relapsed/Refractory Multiple Myeloma

Phase II Study of the Combination of Daratumumab, Ixazomib, Pomalidomide, and Dexamethasone as Salvage Therapy in Relapsed/Refractory Multiple Myeloma A University of California Hematologic Malignancies Consortium Protocol (UCHMC1809)

NCT03590652•University of California, San Diego

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the overall response rate of patients with Multiple Myeloma to the combination of Daratumumab, Ixazomib, Pomalidomide and Dexamethasone.

Detailed Description

The purpose of this study is to determine the overall response rate of patients with Multiple Myeloma to the combination of Daratumumab, Ixazomib, Pomalidomide and Dexamethasone. The drugs being used in this study are daratumumab ixazomib, pomalidomide, and dexamethasone. Ixazomib may stop the growth of cancer by interfering with proteasomes (the protein breakdown mechanism in the cells). Pomalidomide, and dexamethasone are standard drugs that can change and regulate the immune system and may stop cancer cells from growing. Both Ixazomib and Daratumumab are approved for use in Multiple Myeloma, but not in this combination.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•All participants must be registered into the mandatory POMALYST REMS program and be willing and able to comply with the requirements of the POMALYST REMS program.
•Confirmed diagnosis of Multiple Myeloma having received 1 and 3 prior lines of treatment
•Relapsed and/or refractory disease
•Measurable disease
•Life expectancy of more than 3 months
•ECOG performance status of 0, 1, or 2
•No prior progression on pomalidomide
•All pts must have received prior lenalidomide therapy and been determined to be relapsed and/or refractory.
•Adequate hepatic function
•Adequate renal function
+9 more criteria

Exclusion Criteria

•Current or anticipated use of other investigational agents.
•Prior daratumumab or ixazomib use
•Patients who are refractory to pomalidom
•Non-secretory or hyposecretory multiple myeloma defined as:
•Plasma cell leukemia (\>2.0 x 10 9/L circulating plasma cells by standard differential)
•Waldenström's macroglobulinemia or IgM myeloma
•Known central nervous system involvement by multiple myeloma
•Radiotherapy to multiple sites or immunotherapy within 2 weeks before enrollment (localized radiotherapy to a single site at least 1 week before start is permissible)
•Participation in an investigational therapeutic study within 3 weeks or within 5 drug half-lives (t1/2) prior to first dose, whichever time is greater. Non-interventional trials (i.e. observational trials) are permitted at any time point
•Female patients who are lactating or have a positive serum pregnancy test during the screening period.
+12 more criteria

Locations (4)

UCSD Moores Cancer Center

La Jolla, California, United States

University of California, Los Angeles

Los Angeles, California, United States

University of California, Davis

Sacramento, California, United States

University of California, San Francisco

San Francisco, California, United States

Key Dates

Start Date

October 17, 2018

Primary Completion Date

July 2, 2025

Completion Date

July 2, 2025

Last Updated

October 21, 2025

Enrollment

ACTUAL participants

Conditions

Relapsed/Refractory Multiple Myeloma

Interventions

Ixazomib

DRUG

Pomalidomide

DRUG

Dexamethasone

DRUG

Daratumumab-Hyaluronidase-Fihj@1,800 Mg-30,000 Unit/15 mL@SUBCUT@VIAL (ML)

DRUG

A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma

NCT04973605

Relapsed/Refractory Multiple Myeloma

View study

RECRUITINGPHASE1

Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)

NCT05862012

Relapsed/Refractory Multiple Myeloma

View study

RECRUITINGPHASE2

A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Daratumumab, Ixazomib, Pomalidomide, and Dexamethasone as Salvage Therapy in Relapsed/Refractory Multiple Myeloma

Inclusion Criteria

Exclusion Criteria

A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma

Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)

A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

A Study of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) Treated With T-cell Redirectors Outside of Clinical Trials

Study of Naive HBI0101 CAR-T Therapy in Relapsed/Refractory Multiple Myeloma

A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients