What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, such as bortezomib, lenalidomide, and dexamethasone, are associated with several side effects. Bortezomib can cause thrombocytopenia, neuropathy, asthenia, neutropenia, and nausea. Lenalidomide is often linked to neutropenia, thrombocytopenia, and diarrhea. Dexamethasone, when used in combination therapies, can lead to fatigue, pneumonia, and cataracts. These treatments can also result in serious adverse events like sepsis and other infections, which may necessitate discontinuation of therapy.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Multiple Myeloma, often used in combination regimens similar to those studied in the S-TT3 trial. Key drugs include bortezomib, lenalidomide, and dexamethasone, which are frequently used together in various combinations. Other notable approvals include daratumumab, a monoclonal antibody, and carfilzomib, a proteasome inhibitor, both of which are used in combination with other agents for enhanced efficacy. These treatments aim to improve progression-free survival and overall survival in patients with Multiple Myeloma.

What other types of research exist?

Promising novel alternatives to S-TT3 for Multiple Myeloma patients include: 1) Daratumumab-based regimens such as daratumumab, bortezomib, cyclophosphamide, and dexamethasone (dara-CyBorD), which have shown deepened responses and delayed major organ deterioration. 2) Carfilzomib-based regimens like carfilzomib, dexamethasone, and daratumumab (KdD), which have demonstrated efficacy and safety in relapsed or refractory multiple myeloma. 3) Selinexor, bortezomib, and dexamethasone (SVd), which have shown higher overall response rates and prolonged PFS in clinical trials. These alternatives offer promising efficacy and safety profiles for multiple myeloma treatment in 2024.

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Chemotherapy

TT3-LITE Regimen for Multiple Myeloma (TT4B Trial)

Phase 3

Waitlist Available

Research Sponsored by University of Arkansas

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have low-risk disease, as defined by GEP risk score of < 0.66, lack of GEP-defined TP53 deletion, no metaphase based abnormalities of 1q or 1p, LDH <360 U/L, Zubrod ≤ 2, and age between 18 and 75 years.

Patients must be either untreated or have not had more than one cycle of systemic MM therapy, excluding bisphosphonates and localized radiation.

Must not have

High risk disease defined by high-risk gene array features such as GEP risk score of ≥ 0.66, presence of GEP-defined TP53 deletion, or presence of abnormalities of chromosome 1 (amp1q, del 1p).

Platelet count < 30 x 109/L, grade > 2 peripheral neuropathy, hypersensitivity to specific medications, recent (< 6 months) cardiac events, evidence of chronic pulmonary disease, light chain deposition disease, or creatinine > 3 mg/dl.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years from study enrollment

Awards & highlights

Pivotal Trial

All Individual Drugs Already Approved

Approved for 60 Other Conditions

No Placebo-Only Group

Summary

This trial is testing a cancer treatment called S-TT3, which uses high-dose chemotherapy to kill cancer cells. It targets patients needing strong chemotherapy and transplants. The goal is to reduce severe side effects while maintaining treatment effectiveness.

Who is the study for?

This trial is for adults aged 18-75 with newly diagnosed, active Multiple Myeloma that requires treatment and have low-risk disease characteristics. They should not have had more than one cycle of systemic therapy and must be in good general health with proper organ function.

What is being tested?

The study initially aimed to compare a standard treatment (S-TT3) with a less intense version (L-TT3) to see if side effects could be halved. However, it's now only enrolling patients for the S-TT3 after discontinuing randomization into L-TT3.

What are the potential side effects?

Potential side effects may include reactions related to the immune system, blood disorders, kidney or heart problems due to chemotherapy drugs used in the S-TT3 regimen. Specific side effect details are not provided but generally align with high-dose chemotherapy risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is considered low-risk based on specific genetic and health markers.

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I have had no or only one round of treatment for my multiple myeloma, not counting bone treatments or spot radiation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer is considered high risk based on specific genetic test results.

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I do not have severe low platelets, nerve damage, allergies to certain drugs, recent heart issues, chronic lung disease, light chain disease, or high creatinine.

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I do not have uncontrolled high blood pressure, diabetes, or serious mental health issues.

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I am not pregnant, nursing, or if capable of having children, I am using effective birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years from study enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years from study enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years from study enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival rate

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 60 Other Conditions

This treatment demonstrated efficacy for 60 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ARM BExperimental Treatment1 Intervention

The TT3-LITE Regimen (L-TT3) will employ only 1 cycle of induction therapy with MVTD- PACE

Group II: ARM AActive Control1 Intervention

The standard TT3 Regimen (S-TT3) will consist of 2 cycles of induction therapy with M-VTD-PACE and PBSC collection after the 1st cycle. MEL-based tandem transplant will be administered 6 weeks to 3 months apart, applying single dose MEL 200 mg/m2 with adjustments for age and renal function. Consolidation will consist of 2 cycles of dose-reduced VTD-PACE. Maintenance treatment will employ VRD for 3 years.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Multiple Myeloma include proteasome inhibitors like bortezomib, which block the proteasome's function leading to the accumulation of proteins that induce cancer cell death. Immunomodulatory drugs such as lenalidomide enhance the immune system's ability to attack myeloma cells and inhibit their growth. Monoclonal antibodies like daratumumab target specific proteins on the surface of myeloma cells, marking them for destruction by the immune system. Corticosteroids like dexamethasone reduce inflammation and directly kill myeloma cells. These treatments are crucial for Multiple Myeloma patients as they target the disease through different mechanisms, improving response rates and prolonging survival.

How best to use new therapies in multiple myeloma.