Quadruple Therapy for Multiple Myeloma
Recruiting in Palo Alto (17 mi)
Overseen byPrashant Kapoor, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Mayo Clinic
Must not be taking: CYP3A4/5 inhibitors
Disqualifiers: HIV, Hepatitis C, Cardiovascular disease, others
No Placebo Group
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?This phase I/II trial studies the side effects and best dose of iberdomide and how well it works in combination with daratumumab, bortezomib, and dexamethasone in treating patients with newly diagnosed multiple myeloma. Immunotherapy with iberdomide, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving iberdomide in combination with daratumumab, bortezomib, and dexamethasone may kill more cancer cells in patients with newly diagnosed multiple myeloma.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that any additional agents not listed must be approved by the principal investigator, so it's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug combination used in the Quadruple Therapy for Multiple Myeloma?
Research shows that iberdomide, when combined with dexamethasone, has shown promising results in treating multiple myeloma, especially in patients who have already tried other treatments. Additionally, bortezomib combined with dexamethasone has been effective for patients with relapsed or hard-to-treat multiple myeloma.
12345What safety data exists for the quadruple therapy involving Bortezomib, Daratumumab, Dexamethasone, and Iberdomide in humans?
Studies have shown that Bortezomib combined with Dexamethasone is generally safe for treating multiple myeloma, though it may cause some side effects like gastrointestinal issues. Iberdomide with Dexamethasone has also been evaluated for safety in heavily pretreated multiple myeloma patients, indicating it is generally safe but may have side effects.
12367What makes the quadruple therapy for multiple myeloma unique?
This quadruple therapy combines four drugs—Bortezomib, Daratumumab, Dexamethasone, and Iberdomide—to target multiple myeloma in different ways, potentially offering a more comprehensive approach than existing treatments. Bortezomib is a proteasome inhibitor, Daratumumab is an antibody that targets cancer cells, Dexamethasone is a steroid that reduces inflammation, and Iberdomide is a new drug that modulates the immune system, making this combination novel and potentially more effective.
89101112Eligibility Criteria
Adults with newly diagnosed multiple myeloma who haven't been treated or have had only one treatment cycle. They must have measurable disease, be in good physical condition, and have proper organ function. Pregnant or breastfeeding individuals can't join, nor can those unwilling to use contraception or those with certain medical conditions that could interfere with the trial.Inclusion Criteria
I agree not to donate blood during the study.
Negative hepatitis B test
Willingness to provide mandatory bone marrow specimens for correlative research
+11 more
Exclusion Criteria
I have no allergies to study drugs, haven't had major surgery, plasmapheresis, or investigational treatments recently.
I haven't had live vaccines recently and have no cancer history except MM, with some exceptions.
I am HIV positive or have active hepatitis B or C.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Induction
Patients receive iberdomide, bortezomib, dexamethasone, and daratumumab in a 28-day cycle for 12 cycles
48 weeks
4 visits per cycle (in-person)
Maintenance
Patients receive iberdomide monotherapy in a 28-day cycle for up to 36 cycles
24 months
1 visit per cycle (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
3 years
Every 6 months
Participant Groups
The IDEAL study is testing a combination of drugs: Iberdomide (an immunotherapy), Daratumumab (a monoclonal antibody), Bortezomib (blocks enzymes for cell growth), and Dexamethasone (chemotherapy). The goal is to find the best dose of Iberdomide and see how well these drugs work together against multiple myeloma.
1Treatment groups
Experimental Treatment
Group I: Treatment (iberdomide, bortezomib, dexamethasone, daratumumab)Experimental Treatment4 Interventions
INDUCTION PHASE: Patients receive iberdomide PO QD on days 1-21, bortezomib SC on days, 1, 8, 15, and 22, and dexamethasone PO on days 1, 8, 15, 22. Patients also receive daratumumab SC on days 1, 8, 15, 22 of cycles 1 and 2, days 1 and 15 of cycles 3-6, and day 1 of subsequent cycles. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.
CYCLES 13-36 CYCLES: Patients receive iberdomide PO QD on days 1-21. Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity.
Bortezomib is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Velcade for:
- Multiple myeloma
- Mantle cell lymphoma
🇺🇸 Approved in United States as Velcade for:
- Multiple myeloma
- Mantle cell lymphoma
🇨🇦 Approved in Canada as Velcade for:
- Multiple myeloma
- Mantle cell lymphoma
🇯🇵 Approved in Japan as Velcade for:
- Multiple myeloma
- Mantle cell lymphoma
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo Clinic in RochesterRochester, MN
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Iberdomide plus dexamethasone in heavily pretreated late-line relapsed or refractory multiple myeloma (CC-220-MM-001): a multicentre, multicohort, open-label, phase 1/2 trial. [2022]Iberdomide is a novel cereblon E3 ligase modulator with enhanced tumouricidal and immune-stimulatory effects compared with immunomodulatory drugs. In preclinical myeloma models, iberdomide has shown synergy with dexamethasone, proteasome inhibitors, and CD38 monoclonal antibodies. We aimed to evaluate the safety and clinical activity of iberdomide plus dexamethasone in patients with heavily pretreated relapsed or refractory multiple myeloma.
[Bortezomib in combination with dexamethasone for the treatment of relapsed or refractory multiple myeloma]. [2015]To investigate the efficacy and toxicity of bortezomib in combination with dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma(MM).
[Effects of bortezomib at different doses in combination with dexamethasone in treatment of relapsed or refractory multiple myeloma: a comparative study]. [2015]To investigate the efficacy and toxicity of bortezomib of different doses in combination with dexamethasone for the treatment of relapsed or refractory multiple myeloma (MM).
Bortezomib in combination with dexamethasone for the treatment of patients with relapsed and/or refractory multiple myeloma with less than optimal response to bortezomib alone. [2022]The efficacy and safety of added dexamethasone were assessed in patients with relapsed and/or refractory multiple myeloma who had a suboptimal response to bortezomib alone.
Bortezomib or high-dose dexamethasone for relapsed multiple myeloma. [2022]This study compared bortezomib with high-dose dexamethasone in patients with relapsed multiple myeloma who had received one to three previous therapies.
Efficacy and safety of bortezomib plus dexamethasone therapy for refractory or relapsed multiple myeloma: once-weekly administration of bortezomib may reduce the incidence of gastrointestinal adverse events. [2015]To establish the clinical use of bortezomib with fewer adverse events, we retrospectively analyzed the efficacy and safety of bortezomib plus dexamethasone (BD) therapy for relapsed or refractory multiple myeloma.
[Efficacy of bortezomib combined dexamethasone in 24 patients with multiple myeloma]. [2015]Bortezomib, a potent and reversible proteasome inhibitor, induces apoptosis of myeloma cells, resulting in durable responses in patients with multiple myeloma (MM). This study was to explore the medical effects and side effects of bortezomib combined dexamethasone in treating newly diagnosed and relapsed or refractory MM, and evaluate the safety of this regimen in the patients with renal impairment.
Bortezomib in multiple myeloma: a practice guideline. [2015]Bortezomib (Velcade™, PS-341), a first-in-class proteasome inhibitor, has been extensively studied either alone or in combination with other agents for the treatment of multiple myeloma. We created a provincial guideline for the use of bortezomib, in newly diagnosed individuals (both eligible and ineligible for transplant) and in individuals with relapsed or refractory multiple myeloma.
Advantage of achieving deep response following frontline daratumumab-VTd compared to VRd in transplant-eligible multiple myeloma: multicenter study. [2023]The goal of induction therapy for multiple myeloma (MM) is to achieve adequate disease control. Current guidelines favor triplet (bortezomib-lenalidomide-dexamethasone; VRd) or quadruplet regimens (daratumumab, bortezomib-thalidomide-dexamethasone; D-VTd). In the absence of a direct comparison between two treatment regimens, we conducted this study to compare the outcomes and safety of VRd and D-VTd.
Combined bendamustine, prednisone and bortezomib (BPV) in patients with relapsed or refractory multiple myeloma. [2021]Bortezomib (Velcade) is a proteasome inhibitor that has shown important clinical efficacy either as a single agent or in combination with other cytostatic agents in multiple myeloma (MM). In the present protocol, bortezomib was combined with other active substances like bendamustine and prednisone (BPV), in order to assess the efficacy and toxicity of the combination therapy in patients with relapsed or refractory MM.
Cyclophosphamide and Bortezomib With Prednisone or Dexamethasone for the Treatment of Relapsed and Refractory Multiple Myeloma. [2018]Cyclophosphamide, bortezomib, and prednisone (CyBorP) is a highly effective, well-tolerated regimen in relapsed/refractory multiple myeloma. CyBorP, originally developed at our center to include weekly bortezomib (Bor) and alternate-day prednisone (P), was recently modified so that weekly dexamethasone (D) replaced prednisone.
Bortezomib for the treatment of multiple myeloma. [2015]Bortezomib is the first proteasome inhibitor drug tested in human patients. Bortezomib demonstrates a particular clinical utility in the treatment of multiple myeloma (MM), where it is the only one of the new drugs administered as mono-therapy that prolongs survival. The significant problem for the consistent pursuit of bortezomib was neurotoxicity, which has been significantly reduced by registering subcutaneous administration or being administered once per week. Bortezomib is currently approved for the treatment of patients with progressive MM in mono-therapy and in combination with prednisone and melphalan in cases of untreated patients who are not candidates for autologous hematopoietic stem cell transplantation (AHSCT) and in combination with dexamethasone or dexamethasone and thalidomide in untreated MM patients, who are candidates for treatment AHSCT. Clinical research is focused on the combination of bortezomib with other new drugs with the hope of further optimizing the treatment of patients with multiple myeloma.