Relapsed and Refractory Multiple MyelomaPhase 1/2NCT06050512
Mezigdomide Plus Ixazomib and Dexamethasone for Relapsed and Refractory Multiple Myeloma
A Phase 1/2 study testing Mezigdomide, Ixazomib and Dexamethasone in people with Relapsed and Refractory Multiple Myeloma, run by Kathleen Dorritie.
Trial summary
Multiple myeloma (MM) is the second most common hematologic malignancy with an estimated annual incidence of nearly 35,000 cases. While still considered an incurable disease, new treatments have improved outcomes dramatically over the last two decades. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed and Refractory Multiple Myeloma
- What is being tested?
- Mezigdomide, Ixazomib and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 2 Oct 2023to Oct 2026
- Phase
- Phase 1/2
- 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
- ECOG performance status < 2
- Patients must have a confirmed diagnosis of multiple myeloma and have received 1-3 prior lines of therapy and must be:
- Exposed to a proteasome inhibitor, IMiD, and anti-CD38 antibody prior to enrollment. Patients must have measurable evidence of multiple myeloma defined as one of the following:
- Serum M protein ≥ 0.5 g/dL
- Abnormal free light chain ratio, provided involved light chain is >10mg/dL
- Urine M protein ≥ 200 mg/24 hours
Show all 20Show fewer
- Hematologic laboratory parameters of:
- Absolute neutrophil count (ANC) > 1,000/mm3
- Hemoglobin > 8g/dL
- Platelet count > 75,000/μL if plasma cells account for < 50% bone marrow
- Nucleated cells and > 50,000/μL if plasma cells account for > 50% of bone marrow nucleated cells
- Non-hematologic laboratory parameters of:
- Total Bilirubin of < 2 times the upper limit of normal
- ALT and AST < 3 times the upper limit of normal
- Corrected serum calcium >13 mg/dL
- Estimated creatinine clearance (CrCl) of ≥ 45 mL/min, calculated using the formula of Cockroft and Gault (may need adjusted per mezigdomide pharmacokinetic report)
- Access to ixazomib
- Females of childbearing potential (FCBP) must:
- o Have two negative pregnancy tests prior to starting study treatment and agree to ongoing pregnancy testing during the course of the study, and after end of study treatment.
- All male and female participants must follow all requirements defined in the pregnancy prevention plan
Who cannot join
- Central Nervous system involvement of multiple myeloma
- Plasma cell leukemia defined as clonal plasma cells constituting > 20% of peripheral leukocyte differential
- Waldenstrom's Macroglobulinemia, POEMS syndrome or Light Chain (AL) AmyloidosisF
- Prior refractoriness to a proteasome inhibitor (bortezomib, carfilzomib, ixazomib), defined as documented progression within 60 days of a PI-containing regimen
- Prior intolerance of ixazomib
- Prior exposure to mezigdomide
Show all 22Show fewer
- Females with positive pregnancy test during screening or females who wish to become pregnant
- Unwillingness to strictly adhere to the Pregnancy Prevention Plan
- Concomitant or recent (within 2 weeks of starting study therapy) use of strong CYP3A modulators and proton pump inhibitors (PPIs)
- Active cardiopulmonary conditions including documented myocardial ischemia within 6 months, unstable angina, congestive heart failure (New York Heart Association class III or IV), uncontrolled arrythmias, Grade 3 conduction block without a pacemaker, uncontrolled hypertension, baseline QTc >470ms or chronic obstructive pulmonary disease with FEV1 <50%
- Any other malignancy diagnosed within 2 years of enrollment with documented or presumed residual disease, excluding non-melanomatous skin cancer if completely resected
- Active bacterial or fungal infection requiring antimicrobial therapy (not standard prophylactic prophylaxis)
- HIV, chronic or active hepatitis B, or active hepatitis A or C
- Unwillingness to adhere to antithrombotic and antiviral prophylaxis
- Major surgery within 30 days of enrollment
- Radiotherapy within 14 days of initiating study treatment
- Known allergy to any study compounds (mezigdomide, ixazomib)
- Intolerance of dexamethasone
- Documented gastrointestinal disease resulting reduced absorption of oral medications
- Grade > 3 neuropathy
- Active participation in another clinical trial or recent participation within 1 month of enrollment
- Any medical or psychiatric condition interfere with the patient's ability to tolerate or complete this treatment protocol, as determined by principal investigator
About this study
Official title: Phase I/II Trial of Mezigdomide Plus Ixazomib and Dexamethasone for Relapsed and Refractory Multiple Myeloma
Multiple myeloma (MM) is the second most common hematologic malignancy with an estimated annual incidence of nearly 35,000 cases. While still considered an incurable disease, new treatments have improved outcomes dramatically over the last two decades. Around the turn of the millennium, classical cytotoxic chemotherapy and radiation were the only available treatment modalities and median OS was estimated at 2-3 years. Currently, there are now 17 FDA-approved anti-myeloma agents and median OS is approaching 10 years. More recently, next generation cellular and immune therapies are demonstrating unprecedented efficacy in highly refractory patients with otherwise a very short life expectancy. In this study, the starting dose of ixazomib will be reduced to 3mg, as this is the first FDA-recommended dose recommendation (from 4mg). The starting dose of mezigdomide will be 0.6mg. Frequent toxicity and AE monitoring as outlined in this trial (weekly in C1, every 2 weeks in C2-C4) asserts maximization of patient safety. Dexamethasone (DEX) will be dosed at 40mg weekly in patients < 75 years old and 20mg for patients > 76 years old. Additionally, the staring dose of DEX may be reduced to 20mg in any patient, per study provider discretion, based on several factors such frailty, prior adverse side effects or existing comorbidities.
Read the detailed description
Mezigdomide is a novel cereblon E3 ligase modulator (CELMoD). It is an oral small-molecule compound that potentiates the cereblon-mediated ubiquitination of key cellular transcription factors (Ikaros and Aiolos), which ultimately results in multiple myeloma cell death and other immunomodulatory activity. Mezigdomide has demonstrated acceptable safety in two phase I clinical trials in combination with DEX as a "doublet," and as a "triplet" in combination with bortezomib and DEX. Early estimates of efficacy are high compared to historical date: 55% ORR in combination with DEX in a highly pre-treated and refractory patient population, and 75% in combination with bortezomib. By comparison, the most recent oral therapy approved by the FDA for RRMM was Selinexor, which demonstrated a 25% ORR in patients who received a median of 7 prior lines of therapy and 100% of whom were refractory to a PI, IMID and DARA. This comparison serves as very exploratory estimate as no conclusions can be drawn from cross-trial comparisons, especially with very small patient populations. While important efficacy measures such overall survival, progression-free survival and duration of response are maturing, these estimates suggest mezigdomide could be an efficacious, oral treatment option for patients with RRMM.
- Conditions
- Relapsed and Refractory Multiple Myeloma
- Being tested
- Mezigdomide, Ixazomib, Dexamethasone
- Keywords
- Bi-specific T-cell engaging antibodies (BITE), cereblon E3 ligase modulator (CELMoD), cereblon-mediated ubiquitination, cellular transcription factors (Ikaros and Aiolos)
- Medical subject headings
- Recurrence, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MezigdomideDrug
Also called CC-92480, MEZI
Mezigdomide (MEZI), a novel oral CELMoD® agent with enhanced tumoricidal and immune-stimulatory effects compared to immunomodulatory drugs (IMiDs®), induces maximal degradation of Ikaros and Aiolos, leading to increased apoptosis in myeloma cells.
IxazomibDrug
Also called NINLARO®
Ixazomib, a second-generation proteasome inhibitor, is used primarily in the treatment of multiple myeloma. This activity outlines the mechanism of action, indications, and contraindications for ixazomib as a valuable agent for treating multiple myeloma.
DexamethasoneDrug
Also called Dex
Corticosteroids, such as dexamethasone and prednisone, are an important part of the treatment of multiple myeloma. They can be used alone or combined with other drugs as a part of treatment. Corticosteroids are also used to help decrease the nausea and vomiting that chemo might cause.
| Study group | Role | What they receive |
|---|---|---|
| Phase l: Mezigdomide + Ixazomib + Dexamethasone | Experimental | Dose level -2: Mezigdomide: 0.3 mg daily on days 1-21 of a 28-day schedule; Ixazomib: 2.3 mg PO weekly on days 1, 8 and 15 of a 28-day schedule; Dexamethasone: 40 or 20 mg on days 1, 8, 15 and 22 Dose level -1: Mezigdomide: 0.6 mg daily on days 1-21 of a 28-day schedule; Ixazomib: 2.3 mg PO weekly on days 1, 8 and 15 of a 28-day schedule; Dexamethasone: 40 or 20 mg on days 1, 8, 15 and 22 Dose level 0 (Starting dose): Mezigdomide: 0.6 mg daily on days 1-21 of a 28-day schedule; Ixazomib: 3.0 mg PO weekly on days 1, 8 and 15 of a 28-day schedule; Dexamethasone: 40 or 20 mg on days 1, 8, 15 and 22 Dose level +1: Mezigdomide: 1.0 mg daily on days 1-21 of a 28-day schedule; Ixazomib: 3.0 mg PO weekly on days 1, 8 and 15 of a 28-day schedule; Dexamethasone: 40 or 20 mg on days 1, 8, 15 and 22 Dose level +2: Mezigdomide: 1.0 mg daily on days 1-21 of a 28-day schedule; Ixazomib: 4.0 mg PO weekly on days 1, 8 and 15 of a 28-day schedule; Dexamethasone: 40 or 20 mg on days 1, 8, 15 and 22 Receives: Drug: Mezigdomide; Drug: Ixazomib; Drug: Dexamethasone |
| Phase ll (RP2D): Mezigdomide + Ixazomib + Dexamethasone | Experimental | Mezigdomide: RP2D daily on days 1-21 of a 28-day schedule Ixazomib: RP2D PO weekly on days 1, 8 and 15 of a 28-day schedule Dexamethasone: RP2D on days 1, 8, 15 and 22 Receives: Drug: Mezigdomide; Drug: Ixazomib; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase l: Recommended Phase II Dose (RP2D)
Dose-limiting toxicity (DLT) per adverse events as defined using National Cancer Institute (NCI) CTCAE v5.0. Hematologic DLTs: Grade 4 neutropenia < 500/μL for more than 5 days, Grade 3 neutropenia with fever > 38.3°C (one time) or fever > 38.0°C sustained for one hour, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with bleeding; Non-Hematologic DLTs: Grade 3 diarrhea lasting >3 days (not recovering to < grade 2) despite supportive care, Grade 3 nausea or vomiting >3 days (not recovering to < grade 2) days despite supportive care, Grade 3 fatigue lasting >7 days (not recovering to < grade 2) days despite supportive care, Grade 4 diarrhea, Grade 4 nausea or vomiting, Allergic reaction or hypersensitivity if unable to be corrected to <grade 1 within 48 hours, Any other non-hematologic grade >3 toxicity for which there is not a clear alternative explanation; General: dose modification or delay of mezigdomide or ixazomib during cycle 1 due to treatment related toxicity.
Measured: Up to 17 months
Phase ll: Overall Response Rate (ORR)
Preliminary efficacy of mezigdomide when given in combination with ixazomib and dexamethasone as estimated by ORR, as defined by the International Myeloma Working Group (IMWG) response criteria. This will be expressed as the proportion of patients who achieve complete response (CR) or partial response (PR). CR is defined as negative serum and urine M-protein immunofixation (IF), along with the presence of < 5% plasma cells (PCs) in bone marrow (BM) biopsy. PR is defined as ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours.
Measured: Up to 36 months
Secondary outcomes (4)
Incidence and severity of Adverse Events
Incidence and severity of adverse events AEs, as defined by the NCI-Common Terminology Criteria for Adverse Events v5.0, tabulated by type, grade and relatedness to treatment for each dose level achieved in the study and overall.
Measured: Up to 36 months
Depth of Response
Depth of Response will be measured as the proportion of participants in each category, given IMWG Uniform Response Criteria at each dose level and overall.
Measured: Up to 36 months
Duration of Response (DOR)
The time from the date of the earliest documented response (PR, VGPR, CR or sCR) to the earliest date of disease progression or death, whichever occurred first. Disease progression will be determined by the investigator per IMWG Uniform Response Criteria.
Measured: Up to 36 months
Progression-free Survival (PFS)
The time from the date of first treatment to the earliest date of disease progression or death, whichever occurred first. Disease progression will be determined by the investigator per IMWG Uniform Response Criteria.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start2 Oct 2023
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Why it stopped: Closure of trial per BMS
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed and Refractory 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kathleen Dorritie
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor-investigator, Kathleen Dorritie, University of Pittsburgh
- Investigators
- Kathleen A Dorritie, MD, Principal investigator, UPMC Hillman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050512
- Sponsor's protocol ID
- HCC 21-200
- Status last verified
- Nov 2024
- First submitted
- 15 Sep 2023
- Last updated
- 19 Nov 2024
- 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 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial of Mezigdomide Plus Ixazomib and Dexamethasone for Relapsed and Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06050512
- Acronym / sponsor ID
- HCC 21-200
- Conditions
- Relapsed and Refractory Multiple Myeloma
- Keywords
- Bi-specific T-cell engaging antibodies (BITE), cereblon E3 ligase modulator (CELMoD), cereblon-mediated ubiquitination, cellular transcription factors (Ikaros and Aiolos)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Closure of trial per BMS
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kathleen DorritieUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 22 Sep 2023 (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.
Multiple myeloma (MM) is the second most common hematologic malignancy with an estimated annual incidence of nearly 35,000 cases. While still considered an incurable disease, new treatments have improved outcomes dramatically over the last two decades. Around the turn of the millennium, classical cytotoxic chemotherapy and radiation were the only available treatment modalities and median OS was estimated at 2-3 years. Currently, there are now 17 FDA-approved anti-myeloma agents and median OS is approaching 10 years. More recently, next generation cellular and immune therapies are demonstrating unprecedented efficacy in highly refractory patients with otherwise a very short life expectancy. In this study, the starting dose of ixazomib will be reduced to 3mg, as this is the first FDA-recommended dose recommendation (from 4mg). The starting dose of mezigdomide will be 0.6mg. Frequent toxicity and AE monitoring as outlined in this trial (weekly in C1, every 2 weeks in C2-C4) asserts maximization of patient safety. Dexamethasone (DEX) will be dosed at 40mg weekly in patients < 75 years old and 20mg for patients > 76 years old. Additionally, the staring dose of DEX may be reduced to 20mg in any patient, per study provider discretion, based on several factors such frailty, prior adverse side effects or existing comorbidities.
Detailed description
Mezigdomide is a novel cereblon E3 ligase modulator (CELMoD). It is an oral small-molecule compound that potentiates the cereblon-mediated ubiquitination of key cellular transcription factors (Ikaros and Aiolos), which ultimately results in multiple myeloma cell death and other immunomodulatory activity. Mezigdomide has demonstrated acceptable safety in two phase I clinical trials in combination with DEX as a "doublet," and as a "triplet" in combination with bortezomib and DEX. Early estimates of efficacy are high compared to historical date: 55% ORR in combination with DEX in a highly pre-treated and refractory patient population, and 75% in combination with bortezomib. By comparison, the most recent oral therapy approved by the FDA for RRMM was Selinexor, which demonstrated a 25% ORR in patients who received a median of 7 prior lines of therapy and 100% of whom were refractory to a PI, IMID and DARA. This comparison serves as very exploratory estimate as no conclusions can be drawn from cross-trial comparisons, especially with very small patient populations. While important efficacy measures such overall survival, progression-free survival and duration of response are maturing, these estimates suggest mezigdomide could be an efficacious, oral treatment option for patients with RRMM.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase l: Mezigdomide + Ixazomib + Dexamethasone | Experimental | Drug: Mezigdomide, Drug: Ixazomib, Drug: DexamethasoneDose level -2: Mezigdomide: 0.3 mg daily on days 1-21 of a 28-day schedule; Ixazomib: 2.3 mg PO weekly on days 1, 8 and 15 of a 28-day schedule; Dexamethasone: 40 or 20 mg on days 1, 8, 15 and 22 Dose level -1: Mezigdomide: 0.6 mg daily on days 1-21 of a 28-day schedule; Ixazomib: 2.3 mg PO weekly on days 1, 8 and 15 of a 28-day schedule; Dexamethasone: 40 or 20 mg on days 1, 8, 15 and 22 Dose level 0 (Starting dose): Mezigdomide: 0.6 mg daily on days 1-21 of a 28-day schedule; Ixazomib: 3.0 mg PO weekly on days 1, 8 and 15 of a 28-day schedule; Dexamethasone: 40 or 20 mg on days 1, 8, 15 and 22 Dose level +1: Mezigdomide: 1.0 mg daily on days 1-21 of a 28-day schedule; Ixazomib: 3.0 mg PO weekly on days 1, 8 and 15 of a 28-day schedule; Dexamethasone: 40 or 20 mg on days 1, 8, 15 and 22 Dose level +2: Mezigdomide: 1.0 mg daily on days 1-21 of a 28-day schedule; Ixazomib: 4.0 mg PO weekly on days 1, 8 and 15 of a 28-day schedule; Dexamethasone: 40 or 20 mg on days 1, 8, 15 and 22 |
| Phase ll (RP2D): Mezigdomide + Ixazomib + Dexamethasone | Experimental | Drug: Mezigdomide, Drug: Ixazomib, Drug: DexamethasoneMezigdomide: RP2D daily on days 1-21 of a 28-day schedule Ixazomib: RP2D PO weekly on days 1, 8 and 15 of a 28-day schedule Dexamethasone: RP2D on days 1, 8, 15 and 22 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- ECOG performance status < 2
- Patients must have a confirmed diagnosis of multiple myeloma and have received 1-3 prior lines of therapy and must be:
- Exposed to a proteasome inhibitor, IMiD, and anti-CD38 antibody prior to enrollment. Patients must have measurable evidence of multiple myeloma defined as one of the following:
- Hematologic laboratory parameters of:
- Non-hematologic laboratory parameters of:
Key exclusion criteria (22 listed)
- Central Nervous system involvement of multiple myeloma
- Plasma cell leukemia defined as clonal plasma cells constituting > 20% of peripheral leukocyte differential
- Waldenstrom's Macroglobulinemia, POEMS syndrome or Light Chain (AL) AmyloidosisF
- Prior refractoriness to a proteasome inhibitor (bortezomib, carfilzomib, ixazomib), defined as documented progression within 60 days of a PI-containing regimen
- Prior intolerance of ixazomib
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 |
|---|---|---|
| MezigdomideAlso: CC-92480, MEZIMezigdomide (MEZI), a novel oral CELMoD® agent with enhanced tumoricidal and immune-stimulatory effects compared to immunomodulatory drugs (IMiDs®), induces maximal degradation of Ikaros and Aiolos, leading to increased apoptosis in myeloma cells. | Drug | Phase l: Mezigdomide + Ixazomib + Dexamethasone, Phase ll (RP2D): Mezigdomide + Ixazomib + Dexamethasone |
| IxazomibAlso: NINLARO®Ixazomib, a second-generation proteasome inhibitor, is used primarily in the treatment of multiple myeloma. This activity outlines the mechanism of action, indications, and contraindications for ixazomib as a valuable agent for treating multiple myeloma. | Drug | Phase l: Mezigdomide + Ixazomib + Dexamethasone, Phase ll (RP2D): Mezigdomide + Ixazomib + Dexamethasone |
| DexamethasoneAlso: DexCorticosteroids, such as dexamethasone and prednisone, are an important part of the treatment of multiple myeloma. They can be used alone or combined with other drugs as a part of treatment. Corticosteroids are also used to help decrease the nausea and vomiting that chemo might cause. | Drug | Phase l: Mezigdomide + Ixazomib + Dexamethasone, Phase ll (RP2D): Mezigdomide + Ixazomib + Dexamethasone |
Primary outcome
Phase l: Recommended Phase II Dose (RP2D)
Time frame: Up to 17 months
Dose-limiting toxicity (DLT) per adverse events as defined using National Cancer Institute (NCI) CTCAE v5.0. Hematologic DLTs: Grade 4 neutropenia < 500/μL for more than 5 days, Grade 3 neutropenia with fever > 38.3°C (one time) or fever > 38.0°C sustained for one hour, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with bleeding; Non-Hematologic DLTs: Grade 3 diarrhea lasting >3 days (not recovering to < grade 2) despite supportive care, Grade 3 nausea or vomiting >3 days (not recovering to < grade 2) days despite supportive care, Grade 3 fatigue lasting >7 days (not recovering to < grade 2) days despite supportive care, Grade 4 diarrhea, Grade 4 nausea or vomiting, Allergic reaction or hypersensitivity if unable to be corrected to <grade 1 within 48 hours, Any other non-hematologic grade >3 toxicity for which there is not a clear alternative explanation; General: dose modification or delay of mezigdomide or ixazomib during cycle 1 due to treatment related toxicity.
Phase ll: Overall Response Rate (ORR)
Time frame: Up to 36 months
Preliminary efficacy of mezigdomide when given in combination with ixazomib and dexamethasone as estimated by ORR, as defined by the International Myeloma Working Group (IMWG) response criteria. This will be expressed as the proportion of patients who achieve complete response (CR) or partial response (PR). CR is defined as negative serum and urine M-protein immunofixation (IF), along with the presence of < 5% plasma cells (PCs) in bone marrow (BM) biopsy. PR is defined as ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours.
4 secondary outcomes
Incidence and severity of Adverse Events
Time frame: Up to 36 months
Depth of Response
Time frame: Up to 36 months
Duration of Response (DOR)
Time frame: Up to 36 months
Progression-free Survival (PFS)
Time frame: Up to 36 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Relapsed and Refractory Multiple Myeloma
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
RecruitingPhase 1
Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Relapsed Multiple Myeloma, Refractory Multiple Myeloma
RecruitingPhase 1
A Study to Learn About the Effects of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects
Multiple Myeloma (MM)
RecruitingPhase 3
A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
Relapsed or Refractory Multiple Myeloma
RecruitingPhase 1
Radioimmunotherapy (111Indium/225Actinium-DOTA-daratumumab) for the Treatment of Relapsed/Refractory Multiple Myeloma
Recurrent Plasma Cell Myeloma, Refractory Plasma Cell 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.
Kathleen A Dorritie, MD principal investigator
UPMC Hillman Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mezigdomide, Ixazomib and Dexamethasone in people with Relapsed and Refractory Multiple Myeloma, run by Kathleen Dorritie.
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 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: withdrawn, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Phase l: Recommended Phase II Dose (RP2D) (time frame: Up to 17 months). 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 19 Nov 2024.