A Study of Ixazomib+Daratumumab+Dexamethasone (IDd) in Relapsed and/or Refractory Multiple Myeloma (RRMM)

Completed · Phase 2

Conditions studied: Multiple Myeloma

In brief

The purpose of this study is to evaluate the percentage of participants with a response of very good partial response (VGPR) or better to IDd treatment.

Key facts

Study ID: NCT03439293
Run by: Takeda
People needed: 61
Starts: 2018-03-13
Expected to finish: 2023-06-26
Last updated by the study team: 2024-07-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Have measurable disease by at least 1 of the following measurements:
serum M-protein >=1 gram per liter (g/dL) (>=10 g/L).
urine M-protein >=200 mg/24 hours.
Have documented evidence of PD on or after their last regimen as defined by IMWG criteria. All participants must have received between 1 to 3 prior therapies for MM (a prior therapy is defined as 2 or more cycles of therapy given as a treatment plan for MM [example, a single-agent or combination therapy or a sequence of planned treatments such as induction therapy followed by autologous stem cell transplant (SCT) and then consolidation and/or maintenance therapy]).
Have achieved a response (partial response (PR) or better) to at least 1 prior therapy.
Have an Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2.
Must meet the following laboratory criteria:
Absolute neutrophil count (ANC) >=1000 per cubic millimeter (/mm\^3).
Platelet count >=75,000/mm\^3.
Total bilirubin less than or equal to (<=) 1.5*the upper limit of the normal range (ULN) (except for Gilbert syndrome: direct bilirubin <=2*ULN).
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=3*ULN.
Calculated creatinine clearance >=50 mL/min.

You may not qualify if…

Have undergone prior allogenic bone marrow transplantation.
Have received prior ixazomib at any time or daratumumab or other anti-CD38 therapies, except as part of initial therapy if this was stopped to move on to SCT and the participant did not progress on anti-CD38 treatment.
Are refractory to bortezomib or carfilzomib at the last exposure before this study (defined as participants having PD while receiving bortezomib or carfilzomib therapy or within 60 days after ending bortezomib or carfilzomib therapy).
Are planning to undergo SCT prior to PD on this study (ie, these participants should not be enrolled in order to reduce disease burden prior to transplant).
Are receiving systemic treatment with strong Cytochrome P450 3A4 (CYP3A) inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital, St. John's wort) within 14 days before randomization.
Has received autologous SCT within 12 weeks before the date of study treatment.
With known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal. Note: FEV1 testing is required for participants suspected of having COPD and participants must be excluded if FEV1 is <50% of predicted normal.
Participants with Grade 2 or higher residual toxicities from prior therapy (including Grade 2 or higher peripheral neuropathy or any grade neuropathy with pain; excluding alopecia). This includes recovery from any major surgery. Note: Participants with planned surgical to be conducted under local anesthesia may participate. Kyphoplasty or vertebroplasty are not considered major surgery.
Has uncontrolled clinically significant cardiac disease, including myocardial infarction within 6 months before date of study entry or unstable or uncontrolled angina, congestive heart failure, New York Heart Association (NYHA) Class III-IV, uncontrolled cardiac arrhythmia (Grade 2 or higher).
With ongoing or active systemic infection requiring intravenous IV medical management ; participants with known human immunodeficiency virus- Ribonucleic acid (HIV-RNA) positivity; participants with hepatitis B virus (HBV) surface antigen or core antibody positivity; and participants with known hepatitis C virus-RNA positivity. Note: Participants who have positive hepatitis B core antibody can be enrolled but must have hepatitis B virus- deoxyribonucleic acid (DNA) negative. Participants who have positive hepatitis C antibody can be enrolled but must have hepatitis C virus-RNA negativity.
Note: Participants who are already enrolled at the time of Amendment 02 should have local HBV testing performed as soon as possible for HBV surface antigen, e antigen, core antibody, and DNA. If any of these tests is positive, consult a physician with expertise in managing HBV for guidance regarding stopping daratumumab, starting HBV antiviral therapy, and remaining on study.
Diagnosed or treated for another malignancy within 2 years before randomization 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.

Where it is running

Pacific Cancer Medical Center — Anaheim, California, United States
Colorado Blood Cancer Institute — Denver, Colorado, United States
SCRI - Florida Cancer Specialists - Panhandle — Tallahassee, Florida, United States
Research Medical Center - Kansas City — Kansas City, Missouri, United States
SCRI - Tennessee Oncology - Nashville - Centennial — Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
Fakultni Nemocnice Olomouc — Olomouc, Olomouc Region, Czechia
Fakultni Nemocnice Kralovske Vinohrady — Prague, Prague, Czechia
Fakultni Nemocnice Ostrava — Ostrava - Poruba, Severomoravsky KRAJ, Czechia
Fakultni Nemocnice Brno — Brno, Czechia
Onkologicka klinika Vseobecna fakultni nemocnice v Praze a 1 — Prague, Czechia
Centre Hospitalier Lyon Sud — Pierre-Bénite, Auvergne-Rhône-Alpes, France
Hopital Claude Huriez — Lille, Hauts-de-France, France
Hopital Hotel Dieu — Nantes, Pays de la Loire Region, France
Hopital Saint-Antoine — Paris, Île-de-France Region, France
Evaggelismos General Hospital — Athens, Attica, Greece
Alexandra General Hospital of Athens — Athens, Attica, Greece
University General Hospital of Patras Panagia I Voithia — Patras, Peloponnese, Greece
Vrije Universiteit Medisch Centrum — Amsterdam, North Holland, Netherlands
Medisch Centrum Leeuwarden — Leeuwarden, Provincie Friesland, Netherlands
Albert Schweitzer Ziekenhuis Dordwijk — Dordrecht, South Holland, Netherlands
Erasmus Medisch Centrum — Rotterdam, South Holland, Netherlands
Universitair Medisch Centrum Utrecht — Utrecht, Netherlands
Szpital Uniwersytecki w Krakowie — Krakow, Lesser Poland Voivodeship, Poland
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza — Brzozów, Podkarpackie Voivodeship, Poland

Full record on ClinicalTrials.gov

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