Relapsed/Refractory Multiple MyelomaPhase 2NCT03590652
Daratumumab, Ixazomib, Pomalidomide, and Dexamethasone as Salvage Therapy in Relapsed/Refractory Multiple Myeloma
A Phase 2 study testing Ixazomib, Pomalidomide and Dexamethasone in people with Relapsed/Refractory Multiple Myeloma, run by University of California, San Diego at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma
- What is being tested?
- Ixazomib, Pomalidomide and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 4 sitesUnited States
- Study dates
- 17 Oct 2018to 2 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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
- Additional Laboratory Requirements
- ANC ≥1.0 x 10^9/L, Hgb ≥8 g/dL (transfusion permitted)
- Platelet count ≥75 x 10^9/L (≥ 50x10^9/L if bone marrow plasma cells are ≥50% of cellularity)
- Women of child-bearing potential and men with partners of child-bearing potential must agree to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity from the time of signing the informed consent for through 120 days after the last dose of study medication.
- Women of childbearing potential have negative pregnancy test within 72 hours of initiating study drug dosing.
- Male subjects must agree to use a latex condom during sexual contact with females of childbearing potential even if they have had a successful vasectomy starting with the first dose of study therapy through 120 days after the last dose of study therapy.
- All subjects must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
- Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the POMALYST REMS program.
- Subjects must agree to take enteric-coated aspirin 81 mg orally daily, or if history of prior thrombotic disease, must be fully anticoagulated with warfarin (INR 2-3) or be treated with full-dose, low molecular weight heparin, as if to treat deep venous thrombosis (DVT)/pulmonary embolism (PE) at the investigator's discretion.
Who cannot join
- 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
Show all 22Show fewer
- 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.
- Major surgery within 3 weeks prior to first dose
- Myocardial infarction within 6 months prior to enrollment, NYHA (New York Heart Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- Acute active infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose
- Systemic treatment, within 14 days before the first dose of ixazomib, with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John's wort.
- Known or suspected HIV infection, known HIV seropositivity
- Active hepatitis infection
- Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
- Subjects with known or suspected light chain amyloidosis of any organ.
- Known allergies, hypersensitivity, or intolerance to monoclonal antibodies or human proteins, Daratumumab, or its excipients. or known sensitivity to mammalian-derived products.
- Has known chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal
- Has known moderate or severe persistent asthma within the past 2 years per asthma guidelines
- Known gastrointestinal disease or procedure that could interfere with the oral absorption or tolerance of ixazomib or pomalidomide, including difficulty swallowing
Trial locations and contacts
4 sites in 1 country.
United States4 sites
UCSD Moores Cancer Center
La Jolla, California, 92093
University of California, Los Angeles
Los Angeles, California, 90024
University of California, Davis
Sacramento, California, 95817
University of California, San Francisco
San Francisco, California, 94115
About this study
Official title: 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)
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.
Read the 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.
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Being tested
- Ixazomib, Pomalidomide, Dexamethasone, Daratumumab-Hyaluronidase-Fihj@1,800 Mg-30,000 Unit/15 mL@SUBCUT@VIAL (ML)
- Keywords
- multiple myeloma, relapsed/refractory multiple myeloma, Daratumumab, Pomalidomide, Ixazomib, Dexamethasone, cancer, Phase 2, Darzalex, Pomalyst, Ninlaro, Decadron
- Medical subject headings
- Multiple Myeloma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IxazomibDrug
Also called Ninlaro
4mg PO days 1,8,15 on 28-day cycle
PomalidomideDrug
Also called Pomalyst
4mg days PO 1-21/28 days
DexamethasoneDrug
Also called Decadron
40mg** PO weekly
** starting dose for age >75 may be 20mg
Daratumumab-Hyaluronidase-Fihj@1,800 Mg-30,000 Unit/15 mL@SUBCUT@VIAL (ML)Drug
Also called Darzalex Faspro
1800mg SQ weekly x 8 weeks, biweekly x 8 doses, then monthly
| Study group | Role | What they receive |
|---|---|---|
| ixazomib, daratumumab, pomalidomide and dexamethasone | Experimental | Daratumumab will be administered at 16mg/kg IV weekly x 8 weeks, biweekly x 8 weeks, then monthly. Pomalidomide 4mg will be administered orally daily for days 1-21. Patients ≤ age 75 will receive a 40mg dose of dexamethasone, and those over the age of 75 may receive a 20mg dose of dexamethasone orally on days 1, 8, 15, and 22 (weekly). Ixazomib will be administered 4mg orally on days 1, 8 and 15. Receives: Drug: Ixazomib; Drug: Pomalidomide; Drug: Dexamethasone; Drug: Daratumumab-Hyaluronidase-Fihj@1,800 Mg-30,000 Unit/15 mL@SUBCUT@VIAL (ML) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Anti-cancer response as defined by the International Uniform Response Criteria Consensus Recommendations
Measured: 2 years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Treatment-emergent Grade 2-5 adverse events (AEs) will be assessed using NCI CTCAE v4.03 toxicity criteria
Measured: 2 years
Secondary outcomes (6)
Clinical benefit rate
CBR: minimal response +ORR
Measured: 2 years
Progression free survival (PFS)
Progression-free survival (PFS) is defined as the duration of time from start of treatment until objective tumor progression or death
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Time to progression
Time to progression is defined as the duration of time from start of treatment until objective tumor progression.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall survival (OS)
Overall survival is defined as the duration of time from start of treatment to death
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Minimal Residual Disease (MRD)
Assessment on the presence of minimal residual disease for those in stringent complete response
Measured: 1 year
Quality of life (QOL) scores
Cancer Therapy Satisfaction Questionnaire and EORTC QLQ-MY20
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start17 Oct 2018
- Primary completion2 Jul 2025
- Study completion2 Jul 2025
Why it stopped: The trial met its primary endpoint.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caitlin Costello, MD, University of California, San Diego
- Investigators
- Caitlin Costello, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590652
- Sponsor's protocol ID
- 180638
- Status last verified
- Oct 2025
- First submitted
- 21 Jun 2018
- Last updated
- 21 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03590652
- Acronym / sponsor ID
- 180638
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Keywords
- multiple myeloma, relapsed/refractory multiple myeloma, Daratumumab, Pomalidomide, Ixazomib, Dexamethasone, cancer, Phase 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial met its primary endpoint.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Celgene, Takeda, Janssen, LP
- Study start
- 17 Oct 2018 (actual)
- Primary completion
- 2 Jul 2025 (actual)
- Study completion
- 2 Jul 2025 (actual)
- First posted
- 18 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ixazomib, daratumumab, pomalidomide and dexamethasone | Experimental | Drug: Ixazomib, Drug: Pomalidomide, Drug: Dexamethasone, Drug: Daratumumab-Hyaluronidase-Fihj@1,800 Mg-30,000 Unit/15 mL@SUBCUT@VIAL (ML)Daratumumab will be administered at 16mg/kg IV weekly x 8 weeks, biweekly x 8 weeks, then monthly. Pomalidomide 4mg will be administered orally daily for days 1-21. Patients ≤ age 75 will receive a 40mg dose of dexamethasone, and those over the age of 75 may receive a 20mg dose of dexamethasone orally on days 1, 8, 15, and 22 (weekly). Ixazomib will be administered 4mg orally on days 1, 8 and 15. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (22 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IxazomibAlso: Ninlaro4mg PO days 1,8,15 on 28-day cycle | Drug | ixazomib, daratumumab, pomalidomide and dexamethasone |
| PomalidomideAlso: Pomalyst4mg days PO 1-21/28 days | Drug | ixazomib, daratumumab, pomalidomide and dexamethasone |
| DexamethasoneAlso: Decadron40mg** PO weekly ** starting dose for age >75 may be 20mg | Drug | ixazomib, daratumumab, pomalidomide and dexamethasone |
| Daratumumab-Hyaluronidase-Fihj@1,800 Mg-30,000 Unit/15 mL@SUBCUT@VIAL (ML)Also: Darzalex Faspro1800mg SQ weekly x 8 weeks, biweekly x 8 doses, then monthly | Drug | ixazomib, daratumumab, pomalidomide and dexamethasone |
Primary outcome
Overall Response Rate
Time frame: 2 years
Anti-cancer response as defined by the International Uniform Response Criteria Consensus Recommendations
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 2 years
Treatment-emergent Grade 2-5 adverse events (AEs) will be assessed using NCI CTCAE v4.03 toxicity criteria
6 secondary outcomes
Clinical benefit rate
Time frame: 2 years
Progression free survival (PFS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Time to progression
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall survival (OS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Minimal Residual Disease (MRD)
Time frame: 1 year
Quality of life (QOL) scores
Time frame: 2 years
Results and safety
The study was stopped early (reason given: The trial met its primary endpoint.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Relapsed/Refractory Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 3
A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma
Relapsed Refractory Multiple Myeloma (RRMM)
RecruitingPhase 1/2
A Trial to Study if REGN17372 in Combination With Linvoseltamab is Tolerable for Adult Participants With Relapsed/Refractory Multiple Myeloma
Relapsed Refractory Multiple Myeloma (RRMM)
RecruitingPhase 1
A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Participants With Multiple Myeloma That is Resistant to Current Standard of Care Treatments
Multiple Myeloma
RecruitingPhase 1
A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)
Relapsed or Refractory Multiple Myeloma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caitlin Costello, MD principal investigator
University of California, San Diego
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ixazomib, Pomalidomide and Dexamethasone in people with Relapsed/Refractory Multiple Myeloma, run by University of California, San Diego at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The trial met its primary endpoint.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2025; AzTrials last refreshed its copy on 8 Nov 2026.