TT3-LITE Regimen for Multiple Myeloma
(TT4B Trial)

Recruiting in Palo Alto (17 mi)

Overseen byMaurizio Zangari, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: University of Arkansas

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Maurizio Zangari, MD

Principal Investigator

UAMS

Maurizio Zangari, MD

Principal Investigator

UAMS

Eligibility Criteria

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.

Inclusion Criteria

I have newly diagnosed active multiple myeloma needing treatment, or my smoldering myeloma has progressed and now requires chemotherapy.

My kidney, heart, and lung functions meet the required levels.

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

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Exclusion Criteria

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

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.

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Treatment Details

Interventions

M-VTD-PACE (Chemotherapy)
TT3-LITE Regimen (L-TT3) (Chemotherapy)

Trial OverviewThe 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.

Participant Groups

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.