Overview

An Effectiveness and Safety Study of Ixazomib in Combination With Lenalidomide and Dexamethasone (IRD) in Participants With Multiple Myeloma (MM) Previously Receiving a Bortezomib-based Induction Regimen (US MM-6)

Status:
Active, not recruiting
Trial end date:
2026-11-30
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine the progression-free survival (PFS) at 2 years for MM participants previously receiving a bortezomib-based induction regimen to IRD.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Treatments:
BB 1101
Bortezomib
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Glycine
Ixazomib
Lenalidomide
Thalidomide
Criteria
Inclusion Criteria:

1. Must have a diagnosis of a MM using current IMWG diagnostic criteria and have received
1 prior line of therapy.

- Participants must have completed 3 cycles of a bortezomib-based induction regimen
(as defined by current NCCN guidelines) and have no evidence of disease
progression as defined by IMWG criteria.

- Participants with light chain and free light chain (FLC) only may be enrolled if
they meet all the criteria for a diagnosis of MM.

- Participants must be considered by their physician eligible to receiving the IRD
regimen.

2. Must be transplant ineligible as determined by their physician, or if transplant
eligible, not expect to undergo transplant for at least 24 months after study
enrollment.

o Stem cell harvest and mobilization regimen is acceptable if clinically indicated,
but must first be confirmed by the Takeda Medical Monitor.

3. Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance
status 0, 1, or 2 at time of enrollment.

4. Female participants 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 the time of signing the informed consent
form 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 participant (periodic abstinence [example, calendar,
ovulation, symptothermal, post-ovulation methods] and withdrawal are not
acceptable methods of contraception).

5. Male participants, even if surgically sterilized (that is, 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 participant. (Periodic abstinence (example, calendar,
ovulation, symptothermal, post-ovulation methods] and withdrawal are not
acceptable methods of contraception).

Exclusion Criteria:

1. Participation in other interventional 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. Non-interventional trials (that is,
observational trials) are permitted at any time point.

2. Failure to have fully recovered (that is, less than or equal to [<=] Grade 1 toxicity)
from the reversible effects of prior chemotherapy.

3. Major surgery within 14 days before enrollment.

4. Radiotherapy within 14 days before enrollment (if the involved field is small, 7 days
will be considered a sufficient interval between treatment and administration of the
ixazomib).

5. Central nervous system involvement.

6. Infection requiring systemic antibiotic therapy or other serious infection within 14
days before study enrollment.

7. 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.

8. Systemic treatment, within 14 days before the first dose of ixazomib, with strong
cytochrome P450 3A (CYP3A) inducers (rifampin, rifapentine, rifabutin, carbamazepine,
phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort.

9. Ongoing or active systemic infection, active hepatitis B or C virus infection, or
known human immunodeficiency virus positive.

10. Diagnosed or treated for another malignancy within 2 years before study enrollment or
previously diagnosed with another malignancy and have any evidence of residual
disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type
are not excluded if they have undergone complete resection.

11. Has greater than or equal to (>=) Grade 2 peripheral neuropathy, or Grade 1 with pain
on clinical examination during the screening period.

12. Have previously been treated with ixazomib, or participated in a study with ixazomib
whether treated with ixazomib or not.

13. PD on first-line therapy.