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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 belowSelect...
My cancer is considered low-risk based on specific genetic and health markers.
Select...
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:Select...
My cancer is considered high risk based on specific genetic test results.
Select...
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.
Select...
I do not have uncontrolled high blood pressure, diabetes, or serious mental health issues.
Select...
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
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.
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.
How best to use new therapies in multiple myeloma.
Find a Location
Who is running the clinical trial?
Millennium Pharmaceuticals, Inc.Industry Sponsor
404 Previous Clinical Trials
46,532 Total Patients Enrolled
82 Trials studying Multiple Myeloma
9,680 Patients Enrolled for Multiple Myeloma
University of ArkansasLead Sponsor
494 Previous Clinical Trials
150,237 Total Patients Enrolled
54 Trials studying Multiple Myeloma
11,598 Patients Enrolled for Multiple Myeloma
Maurizio Zangari, MDStudy DirectorUAMS
6 Previous Clinical Trials
232 Total Patients Enrolled
5 Trials studying Multiple Myeloma
72 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have newly diagnosed active multiple myeloma needing treatment, or my smoldering myeloma has progressed and now requires chemotherapy.My cancer is considered high risk based on specific genetic test results.My kidney, heart, and lung functions meet the required levels.I have no cancer history, except for certain skin cancers or in situ cervical cancer, and have been cancer-free for 3 years if I had another type.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.My cancer is considered low-risk based on specific genetic and health markers.I do not have uncontrolled high blood pressure, diabetes, or serious mental health issues.I am not pregnant, nursing, or if capable of having children, I am using effective birth control.I have had no or only one round of treatment for my multiple myeloma, not counting bone treatments or spot radiation.
Awards:
This trial has 4 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: ARM B
- Group 2: ARM A
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