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Chemotherapy

TT3-LITE Regimen for Multiple Myeloma (TT4B Trial)

Q: Is this study only for elderly individuals, or will it accept people of all ages?

The age limit for this study is 75 years old, with a minimum age of 18.

Q: What are the effects of TT3-LITE Regimen (L-TT3)?

The <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a> treatments of Kaposi's <a href="https://www.withpower.com/clinical-trials/sarcoma">Sarcoma</a>, <a href="https://www.withpower.com/clinical-trials/aids">AIDS</a> related Merkel cell cancer, and <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a> can <a href="https://www.withpower.com/clinical-trials/all">all</a> be executed using the TT3-LITE Regimen (L-TT3).

Q: Are there any dangers associated with the TT3-LITE Regimen (L-TT3)?

We believe that the TT3-LITE Regimen (L-TT3) is safe to use because it is a Phase 3 trial. This means that there is data supporting both its efficacy and safety.

Q: Are people still being asked to participate in this research?

This trial is not recruiting patients at the moment, according to the most recent update on September 12th, 2022. The study was originally posted on July 1st, 2008. There are 826 other trials recruiting patients with <a href="https://www.withpower.com/clinical-trials/multiple-myeloma">multiple myeloma</a> and 2282 trials for the TT3-LITE Regimen (L-TT3) if you are searching for other studies.

Q: Will this study pave the way for similar research in the future?

TT3-LITE Regimen (L-TT3) has a long and well-documented clinical history, with the first study completed in 1997. Alfacell sponsored the first Phase 3 clinical trial, and following its success, the regimen received drug approval. In the present day, 2282 active studies involving TT3-LITE Regimen (L-TT3) are taking place in 4017 cities across 87 countries.

Q: Could I review the screening process for this trial?

This study is recruiting 382 patients, within the ages of 18 and 75 who currently have <a href="https://www.withpower.com/clinical-trials/multiple-myeloma">multiple myeloma</a>. It is required that patients also meet the following criteria: Patients must have newly diagnosed active MM requiring treatment. Patients with a previous history of smoldering myeloma will be eligible if there is evidence of progressive disease requiring chemotherapy., Patients must be either untreated or have not had more than one cycle of systemic MM therapy, excluding bisphosphonates and localized radiation., GEP risk score of &#x3C; 0.66, No metaphase based abnormalities of 1q or 1p, Patients must be at least 18 years

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years from study enrollment

Awards & highlights

TT4B Trial Summary

This trial is testing whether a lower dose of TT3 will reduce treatment-related toxicities while still being effective.

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.Check my eligibility

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.See study design

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.

TT4B Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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.

TT4B Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival rate

TT4B 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 / 2Eligibility criteria met

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

486 Previous Clinical Trials

149,971 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

M-VTD-PACE (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT00734877 — Phase 3

Multiple Myeloma Clinical Trial 2023: M-VTD-PACE Highlights & Side Effects. Trial Name: NCT00734877 — Phase 3

M-VTD-PACE (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00734877 — Phase 3

Multiple Myeloma Research Study Groups: ARM B, ARM A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study only for elderly individuals, or will it accept people of all ages?

"The age limit for this study is 75 years old, with a minimum age of 18."

Answered by AI

What are the effects of TT3-LITE Regimen (L-TT3)?

"The cancer treatments of Kaposi's Sarcoma, AIDS related Merkel cell cancer, and leukemia can all be executed using the TT3-LITE Regimen (L-TT3)."

Answered by AI

Are there any dangers associated with the TT3-LITE Regimen (L-TT3)?

"We believe that the TT3-LITE Regimen (L-TT3) is safe to use because it is a Phase 3 trial. This means that there is data supporting both its efficacy and safety."

Answered by AI

Are people still being asked to participate in this research?

"This trial is not recruiting patients at the moment, according to the most recent update on September 12th, 2022. The study was originally posted on July 1st, 2008. There are 826 other trials recruiting patients with multiple myeloma and 2282 trials for the TT3-LITE Regimen (L-TT3) if you are searching for other studies."

Answered by AI

Will this study pave the way for similar research in the future?

"TT3-LITE Regimen (L-TT3) has a long and well-documented clinical history, with the first study completed in 1997. Alfacell sponsored the first Phase 3 clinical trial, and following its success, the regimen received drug approval. In the present day, 2282 active studies involving TT3-LITE Regimen (L-TT3) are taking place in 4017 cities across 87 countries."

Answered by AI

Could I review the screening process for this trial?

"This study is recruiting 382 patients, within the ages of 18 and 75 who currently have multiple myeloma. It is required that patients also meet the following criteria: Patients must have newly diagnosed active MM requiring treatment. Patients with a previous history of smoldering myeloma will be eligible if there is evidence of progressive disease requiring chemotherapy., Patients must be either untreated or have not had more than one cycle of systemic MM therapy, excluding bisphosphonates and localized radiation., GEP risk score of < 0.66, No metaphase based abnormalities of 1q or 1p, Patients must be at least 18 years"

Answered by AI

Recent research and studies

HaematologicaJournal

Treatment to Suppression of Focal Lesions on Positron Emission Tomography-computed Tomography Is a Therapeutic Goal in Newly Diagnosed Multiple Myeloma

Davies, Faith E., Adam Rosenthal, Leo Rasche, Nathan M. Petty, James E. McDonald, James A. Ntambi, Doug M. Steward, et al.. 2018. “Treatment to Suppression of Focal Lesions on Positron Emission Tomography-computed Tomography Is a Therapeutic Goal in Newly Diagnosed Multiple Myeloma”. Haematologica. Ferrata Storti Foundation (Haematologica). doi:10.3324/haematol.2017.177139.

HaematologicaJournal

Extramedullary Disease Portends Poor Prognosis in Multiple Myeloma and Is Over-represented in High-risk Disease Even in the Era of Novel Agents

Usmani, S. Z., C. Heuck, A. Mitchell, J. Szymonifka, B. Nair, A. Hoering, Y. Alsayed, et al.. 2012. “Extramedullary Disease Portends Poor Prognosis in Multiple Myeloma and Is Over-represented in High-risk Disease Even in the Era of Novel Agents”. Haematologica. Ferrata Storti Foundation (Haematologica). doi:10.3324/haematol.2012.065698.

clinicaltrials.govStudy

UARK 2013-13, Total Therapy 4B - Formerly 2008-01 - A Phase III Trial for Low Risk Myeloma

2008. "UARK 2013-13, Total Therapy 4B - Formerly 2008-01 - A Phase III Trial for Low Risk Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00734877.

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