NCT03733691

Ph 2 Maintenance Trial: Ixazomib vs Ixazomib-Lenalidomide for MM Patients

A Phase 2, Open Label, Randomized Trial Evaluating Ixazomib Compared to Ixazomib-Lenalidomide Combination Maintenance Therapy for Frontline Multiple Myeloma Patients

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Oncotherapeutics · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, Phase 2 study involving two arms evaluating the efficacy and safety of ixazomib alone and the combination of both ixazomib and lenalidomide as maintenance therapy for patients with multiple myeloma who have achieved at least partial response (PR) or better after receiving a bortezomib- and lenalidomide-containing combination front-line therapy.

Detailed description

Patients who have achieved PR or better on a bortezomib- and lenalidomide-containing combination therapy will be randomized to receive maintenance therapy with 28-day cycles of either ixazomib alone or the combination of ixazomib and lenalidomide. If steroids were part of the patient's qualifying regimen, steroids will be administered using the same drug(s), schedule(s) and dose(s) as those of the last treatment cycle of the bortezomib-, lenalidomide- and steroid-containing regimen. Ixazomib will be administered per orem (PO) at 3 mg on days 1, 8 and 15 of 28-day cycles. Lenalidomide will be taken PO, once daily at the same dose as the last treatment on days 1 through 28 of the 28-day cycles. Patients will start the randomized maintenance therapy after receiving a minimum of 6 cycles of a bortezomib- and lenalidomide-containing combination treatment but may have received up to 8 cycles if they continued to show improvement in their response after the first 6 cycles. During cycle 1, patients will have clinical laboratory tests weekly (days 1, 8, 15 and 22) and MM disease assessments on day 22 to monitor for efficacy and potential toxicity. Beginning with cycle 2, patients will have clinical laboratory tests performed twice a month and MM disease assessments once a month. Patients will be treated until documentation of PD or if subject meets any of the treatment discontinuation criteria.

Conditions

• Newly Diagnosed Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Ixazomib	3 mg oral capsule, Days 1, 8 and 15 of 28-day cycles
DRUG	Lenalidomide	Same dose as in the front-line treatment in the last treatment cycle, taken orally, on days 1-28 of a 28-day cycle.

Timeline

• Start date: 2019-03-01
• Primary completion: 2023-10-19
• Completion: 2023-10-19
• First posted: 2018-11-07
• Last updated: 2023-10-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study