Multiple MyelomaPhase 1/2NCT04094961
Ixazomib + Pomalidomide + Dexamethasone In MM
A Phase 1/2 study testing Ixazomib, Pomalidomide and Dexamethasone in people with Multiple Myeloma and Multiple Myeloma in Relapse, run by Omar Nadeem, MD at 1 site in United States.
Trial summary
This is a Phase I/II study using the combination of twice weekly ixazomib plus pomalidomide and dexamethasone in relapsed and or refractory multiple myeloma (RRMM) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Multiple Myeloma in Relapse
- What is being tested?
- Ixazomib, Pomalidomide and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2019to 1 Jan 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Patients with relapsed and relapsed refractory myeloma may be eligible for this trial of they meet all the following entry criteria.
- Previously diagnosed with MM based on standard IMWG criteria and currently requires treatment.
- Patient has given voluntary written informed consent before performance of any study-related procedures not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care
- Patient had received at least two previous therapies OR received 1 prior line of therapy if previously treated with an IMiD plus a proteasome inhibitor and has demonstrated disease progression on or within 60 days of completion of the last therapy
- Patient has measurable disease defined as at least one of the following according to Standard Diagnostic Criteria (Rajkumar 2014):
- Serum IgG, IgA, or IgM M-protein ≥ 0.5 g/dL, or
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- Serum IgD M-protein ≥ 0.05 g/dL, or
- Urine M protein ≥200 mg/24 hours or
- Serum free light chain (FLC) assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65)
- Screening Laboratory evaluations within the following parameters
- Absolute neutrophil count (ANC) ≥ 1,000 cells/dL (1.0 x 109/L) (Growth factors cannot be used more recently than 14 days prior to initiation of therapy)
- Platelet count ≥ 75,000 cells/dL (75 x 109/L) (without transfusions required during the 14 days prior to initiation of therapy)
- Hemoglobin ≥ 8.0 g/dl (RBC transfusions are permitted)
- Total Bilirubin ≤ 1.5 X upper limit of normal (ULN) (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
- AST (SGOT) and ALT (SGPT) ≤ 3.0 x ULN
- Calculated creatinine clearance ≥ 45 mL/min
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
- All study 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.
- Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the POMALYST REMS® program.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Prior exposure to ixazomib OR is refractory to pomalidomide
- Patients that have previously been treated with ixazomib, or participated in a study with ixazomib,whether treated with the agent or not, are also excluded
- Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial.
- Diagnosed or treated for another malignancy within 3 years prior to enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low risk prostate cancer after curative therapy.
- Known GI disease or is in need of, or has had a previous GI procedure that could interfere with the oral absorption or tolerance of ixazomib or pomalidomide including difficulty swallowing.
- Known central nervous system involvement.
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- Systemic treatment, within 14 days before the first dose of treatment, with strong CYP3A or inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John's wort OR systemic treatment within 14 days of the first dose of treatment with a strong inhibitor of CYP1A2 (ciprofloxacin, fluvoxamine, cimetidine, enoxacin, ethynyl estradiol, mexiletine)
- Any medical or psychiatric illness/social situation that in the Investigator's opinion, would impose excessive risk to the patient, would adversely affect his/her participating in this study or would limit compliance with study requirements.
- Any active, or uncontrolled cardiovascular conditions, including but not limited to uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, grade 3 thromboembolic event or myocardial infarction within the past 6 months.
- The following therapies within the stated time frames prior to initiation of therapy:
- Previous cytotoxic therapies, including cytotoxic investigational agents, for multiple myeloma within 21 days (42 days for nitrosoureas).
- The use of live vaccines within 30 days.
- ImiDs or proteasome inhibitors within 14 days.
- Other investigational therapies and/or monoclonal antibodies within 4 weeks.
- Prior peripheral stem cell transplant within 12 weeks.
- Prior allogeneic stem cell transplantation with active graft-versus-host-disease.
- Currently active graft versus host disease of any stage or grade after allogeneic stem cell transplantation
- Prior major surgical procedure or radiation therapy within 14 days of initiation of therapy.
- Those who require a limited course of radiation for management of bone pain more than 14 days out from initiation of therapy are not excluded
- If the involved field is small, 7 days will be considered a sufficient interval between radiotherapy and administration of the ixazomib.
- Daily requirement for corticosteroids (equivalent to > 10 mg/day prednisone, though >10mg/day is acceptable if physiological levels require, so long as the dose is stable for at least 7 days prior to initiation of therapy. Inhalation corticosteroids are exempt from this criterion.
- -- Lower amounts of corticosteroids that are not part of a daily requirement within 14 days prior to initiating therapy
- Concurrent symptomatic amyloidosis or plasma cell leukemia
- POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes)
- Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment.
- -- Those who are on prophylactic antibiotics only, or on antibiotics and have confirmation of resolution of active infection are eligible.
- Known seropositive for active viral infection with human immunodeficiency virus (HIV) hepatitis B (HBV) or hepatitis C viral (HCV). Those who are seropositive because of hepatitis B vaccine are eligible. Patients who are positive for HBV core antibody or HBV surface antigen must have a negative polymerase chain reaction (PCR) result prior to enrollment. Those who are PCR positive will be excluded
- Female patients who are lactating or have a positive serum pregnancy test during the screening period
- Participants who are receiving any other investigational agents for any indication
- History of erythema multiforme or severe hypersensitivity to prior IMiD's® or those who have a known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
- Inability to tolerate thromboprophylaxis
- Failure to have fully recovered (≤ Grade 1 according to CTCAE v 5) from the reversible effects of prior chemotherapy
- Peripheral neuropathy must have resolved to Grade 1 toxicity or peripheral neuropathy grade 2 with no pain to be eligible
- Alopecia of any grade is eligible
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Phase I/II Study of Twice Weekly Ixazomib Plus Pomalidomide and Dexamethasone in Relapsed/or Refractory Multiple Myeloma
This is a Phase I/II study using the combination of twice weekly ixazomib plus pomalidomide and dexamethasone in relapsed and or refractory multiple myeloma (RRMM) patients.
Read the detailed description
This is a Phase I/II clinical trial. A Phase I clinical trial tests the safety of an investigational drug and tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied.
The FDA has approved both pomalidomide and ixazomib individually for the treatment of multiple myeloma. Dexamethasone, also FDA approved, is a type of steroid and is usually combined with other chemotherapy for the treatment of blood cancers, such as myeloma and leukemias.
- Ixazomib targets a part of cells called proteasomes. It works by slowing down or blocking proteasomes from doing their job of digesting proteins. In myeloma cells, there is a greater need for proteasomes to digest proteins; the buildup of excess proteins causes cell death.
- Pomalidomide has also been shown to cause tumor cell deaths. Dexamethasone can stop white blood cells from traveling to areas myeloma cells are causing damage. When combined with myeloma drugs, it sometimes makes those drugs work better.
In this research study, the investigators are:
- Testing the safety of ixazomib when given with pomalidomide and dexamethasone
- Pomalidomide and ixazomib are given individually for the treatment of multiple myeloma. Dexamethasone is also given for multiple myeloma
- Ixazomib when combined with pomalidomide and dexamethasone may help control the disease
- Ixazomib is FDA approved to treat multiple myeloma
- The investigators are looking for the highest dose of ixazomib that can be given safely in combination with pomalidomide and dexamethasone
- Conditions
- Multiple Myeloma, Multiple Myeloma in Relapse
- Being tested
- Ixazomib, Pomalidomide, Dexamethasone
- Keywords
- Multiple Myeloma, Multiple Myeloma in Relapse
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IxazomibDrug
Also called Ninlaro®
Oral, administered four times per cycle
PomalidomideDrug
Also called Pomalyst®
Oral, administered 14 times per cycle
DexamethasoneDrug
Also called Baycadron, Decadron, Dexamethasone Intensol, DexPak
Oral, fixed dose administered 8 times per cycle
| Study group | Role | What they receive |
|---|---|---|
| ixazomib plus pomalidomide and dexamethasone | Experimental | The study drugs will be administered within a 21-day cycle
* Phase I will follow a standard "3 +3" dose escalation design: Starting with the first cohort, 3 to 6 patients will be treated at this and each subsequent dose level.
* The Phase II portion of the study will be a single-arm open-label enrollment with dosing based on the MTD determination in the Phase I portion of the study Receives: Drug: Ixazomib; Drug: Pomalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose limiting toxicity
3 - 24 safety evaluable patients will be enrolled in up to 4 dose levels of ixazomib, pomalidomide and dexamethasone.
Measured: 21 Days
Overall Response Rate
Response will be evaluated using a Simon optimal two-stage design
Measured: 28 days
Secondary outcomes (4)
Time to Progression
Estimated using the method of Kaplan-Meier.
Measured: time from first dose of study drug to progression, censored at date last known progression-free for those who have not progressed, whichever came first, assessed up to 60 months
Progression Free Survival
Estimated using the method of Kaplan-Meier.
Measured: time from first dose of study drug to the disease progression or death from any cause, censored at date last known progression-free for those who have not progressed or died, whichever came first, assessed up to 60 months
Duration of Response
Estimated using the method of Kaplan-Meier.
Measured: time from response to disease progression or death, or date last known progression-free and alive for those who have not progressed or died, whichever came first, assessed up to 60 months
Overall Survival
Estimated using the method of Kaplan-Meier.
Measured: time from first dose of study drug to death or date last known alive, whichever came first, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start18 Sep 2019
- Primary completion1 Jun 2025
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omar Nadeem, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Sponsor-investigator, Omar Nadeem, MD, Dana-Farber Cancer Institute
- Investigators
- Omar Nadeem, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094961
- Sponsor's protocol ID
- 19-291
- Status last verified
- Mar 2026
- First submitted
- 10 Sep 2019
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Twice Weekly Ixazomib Plus Pomalidomide and Dexamethasone in Relapsed/or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04094961
- Acronym / sponsor ID
- 19-291
- Conditions
- Multiple Myeloma, Multiple Myeloma in Relapse
- Keywords
- Multiple Myeloma, Multiple Myeloma in Relapse
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Omar Nadeem, MDUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 19 Sep 2019 (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.
This is a Phase I/II study using the combination of twice weekly ixazomib plus pomalidomide and dexamethasone in relapsed and or refractory multiple myeloma (RRMM) patients.
Detailed description
This is a Phase I/II clinical trial. A Phase I clinical trial tests the safety of an investigational drug and tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied.
The FDA has approved both pomalidomide and ixazomib individually for the treatment of multiple myeloma. Dexamethasone, also FDA approved, is a type of steroid and is usually combined with other chemotherapy for the treatment of blood cancers, such as myeloma and leukemias.
- Ixazomib targets a part of cells called proteasomes. It works by slowing down or blocking proteasomes from doing their job of digesting proteins. In myeloma cells, there is a greater need for proteasomes to digest proteins; the buildup of excess proteins causes cell death.
- Pomalidomide has also been shown to cause tumor cell deaths. Dexamethasone can stop white blood cells from traveling to areas myeloma cells are causing damage. When combined with myeloma drugs, it sometimes makes those drugs work better.
In this research study, the investigators are:
- Testing the safety of ixazomib when given with pomalidomide and dexamethasone
- Pomalidomide and ixazomib are given individually for the treatment of multiple myeloma. Dexamethasone is also given for multiple myeloma
- Ixazomib when combined with pomalidomide and dexamethasone may help control the disease
- Ixazomib is FDA approved to treat multiple myeloma
- The investigators are looking for the highest dose of ixazomib that can be given safely in combination with pomalidomide and dexamethasone
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ixazomib plus pomalidomide and dexamethasone | Experimental | Drug: Ixazomib, Drug: Pomalidomide, Drug: DexamethasoneThe study drugs will be administered within a 21-day cycle * Phase I will follow a standard "3 +3" dose escalation design: Starting with the first cohort, 3 to 6 patients will be treated at this and each subsequent dose level. * The Phase II portion of the study will be a single-arm open-label enrollment with dosing based on the MTD determination in the Phase I portion of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patients with relapsed and relapsed refractory myeloma may be eligible for this trial of they meet all the following entry criteria.
- Previously diagnosed with MM based on standard IMWG criteria and currently requires treatment.
- Patient has given voluntary written informed consent before performance of any study-related procedures not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care
- Patient had received at least two previous therapies OR received 1 prior line of therapy if previously treated with an IMiD plus a proteasome inhibitor and has demonstrated disease progression on or within 60 days of completion of the last therapy
- Patient has measurable disease defined as at least one of the following according to Standard Diagnostic Criteria (Rajkumar 2014):
Key exclusion criteria (34 listed)
- Prior exposure to ixazomib OR is refractory to pomalidomide
- Patients that have previously been treated with ixazomib, or participated in a study with ixazomib,whether treated with the agent or not, are also excluded
- Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial.
- Diagnosed or treated for another malignancy within 3 years prior to enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low risk prostate cancer after curative therapy.
- Known GI disease or is in need of, or has had a previous GI procedure that could interfere with the oral absorption or tolerance of ixazomib or pomalidomide including difficulty swallowing.
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: Ninlaro®Oral, administered four times per cycle | Drug | ixazomib plus pomalidomide and dexamethasone |
| PomalidomideAlso: Pomalyst®Oral, administered 14 times per cycle | Drug | ixazomib plus pomalidomide and dexamethasone |
| DexamethasoneAlso: Baycadron, Decadron, Dexamethasone Intensol, DexPakOral, fixed dose administered 8 times per cycle | Drug | ixazomib plus pomalidomide and dexamethasone |
Primary outcome
Number of participants with dose limiting toxicity
Time frame: 21 Days
3 - 24 safety evaluable patients will be enrolled in up to 4 dose levels of ixazomib, pomalidomide and dexamethasone.
Overall Response Rate
Time frame: 28 days
Response will be evaluated using a Simon optimal two-stage design
4 secondary outcomes
Time to Progression
Time frame: time from first dose of study drug to progression, censored at date last known progression-free for those who have not progressed, whichever came first, assessed up to 60 months
Progression Free Survival
Time frame: time from first dose of study drug to the disease progression or death from any cause, censored at date last known progression-free for those who have not progressed or died, whichever came first, assessed up to 60 months
Duration of Response
Time frame: time from response to disease progression or death, or date last known progression-free and alive for those who have not progressed or died, whichever came first, assessed up to 60 months
Overall Survival
Time frame: time from first dose of study drug to death or date last known alive, whichever came first, assessed up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
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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.
Omar Nadeem, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ixazomib, Pomalidomide and Dexamethasone in people with Multiple Myeloma and Multiple Myeloma in Relapse, run by Omar Nadeem, MD at 1 site 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 20 inclusion and 34 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: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
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?
Number of participants with dose limiting toxicity (time frame: 21 Days). 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 5 Mar 2026.