A Phase 3 trial of thalidomide-dexamethasone consolidation versus thalidomide-dexamethasone-Ixazomib consolidation for transplant eligible multiple myeloma patients undergoing a single autologous stem cell transplantation as part of front-line therapy

Phase 3

Active, not recruiting

• Conditions: Multiple Myeloma; Cancer - Myeloma

• Registration Number: ACTRN12616000772448
• Lead Sponsor: Australasian Leukaemia and Lymphoma Group (ALLG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-14
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 189

Inclusion Criteria

Each patient must meet all of the following inclusion criteria to be enrolled in the study:
1.Male or female patients 18 years or older.
2.Voluntary written informed consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
3. Patients must have a diagnosis of a symptomatic MM as per IMWG criteria and be eligible for front-line melphalan conditioned ASCT, with > 2x 10^6 CD34/Kg available for ASCT.
4.Female patients who:
- Are postmenopausal for at least 1 year before the screening visit, OR
- Are surgically sterile, OR
- If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from 4 weeks before the start of study treatment and during the entire study treatment period and through 90 days after the last dose of the study drugs, OR
- Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception).
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:
- Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR
- Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception).
5.Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
6.Patients must meet the following clinical laboratory criteria:
- Absolute neutrophil count (ANC) >= 1,000/mm^3 and platelet count >= 75,000/mm^3. Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment.
- Total bilirubin <= 1.5 x the upper limit of the normal range (ULN).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3 x ULN.
- Calculated creatinine clearance >= 30 mL/min per Cockcroft-Gault equation.

Exclusion Criteria

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
1.Female patients who are lactating or have a positive serum pregnancy test during the screening period.
2.Failure to have fully recovered (i.e., <= Grade 1 toxicity) from the reversible effects of prior chemotherapy.
3.Progressive disease post-ASCT
4.Failure of haemopoietic recovery post-ASCT
5.Major surgery within 14 days before enrolment.
6.Radiotherapy within 14 days before enrolment. If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib.
7.Central nervous system involvement with the disease under study (myeloma).
8.Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrolment.
9.Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.
10.Systemic treatment, within 14 days before the first dose of ixazomib, with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John’s wort.
11.Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive.
12.Any serious medical or psychiatric condition (including uncontrolled infection) that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol or would be a contraindication to consolidation/maintenance therapy
13.Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
14.Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing.
15.Diagnosed or treated for another malignancy within 2 years before study enrolment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
16.Patient has >= Grade 2 peripheral neuropathy, or Grade 1 with pain on clinical examination during the screening period.
17.Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial.
18.Contraindication to the use of either thalidomide, ixazomib or dexamethasone

Study & Design

• Study Type: Interventional
• Study Design: Not specified