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

Browse trials for

• Multiple Myeloma 3,627
• Neoplasms, Plasma Cell 2,308

Keywords

• Drug Therapy
• Ixazomib
• Daratumumab
• Dexamethasone

Study arms

• Experimental
  Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg

  Ixazomib, 4 mg, capsules, orally, on Days 1, 8 and 15 of each 28-day cycle along with daratumumab, 16 mg/kg, intravenously (IV), on Days 1, 8, 15 and 22 of Cycles 1 and 2, on Days 1 and 15 (every 2 weeks) for Cycles 3 to 6 and on Day 1 (every 4 weeks) for Cycle 7 and beyond along with dexamethasone, 20 mg, tablets, orally on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day cycle until progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or up to 5 years.

  Drug: Ixazomib · Drug: Daratumumab · Drug: Dexamethasone

Interventions

• DrugIxazomib

  Ixazomib capsule.

  Also known as: NINLARO

• DrugDaratumumab

  Daratumumab IV infusion.

• DrugDexamethasone

  Dexamethasone tablets.

Primary outcomes

1. Percentage of Participants With Very Good Partial Response (VGPR) or Better (Complete Response + VGPR)

   Response was assessed using International Myeloma Working Group (IMWG) Criteria. VGPR is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 milligram (mg) per 24 hours. The percentage of participants were rounded off to the single decimal point.

   Time frame: Up to 5 years

Secondary outcomes

1. Progression-free Survival (PFS)

   PFS is defined as time from date of first dose of drug to date of first documentation of progressive disease (PD) or death from any cause, whichever occurs first. Participant without documentation of PD or death were censored at the date of last response assessment that is stable disease (SD) or better. PD is defined as increase of 25% of lowest response value in one or more of following criteria: serum M-component (absolute increase ≥0.5 g/dl); or urine M-component (absolute increase ≥200 mg/24-hour); difference between involved and uninvolved FLC levels (absolute increase \>10 mg/dl); or bone marrow plasma cell percentage (absolute plasma cell percentage ≥10%); development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma; or development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder. SD is defined as not meeting criteria for other responses.

   Time frame: Up to 5 years

2. Time to Progression (TTP)

   TTP is defined as the time from the first dose of any study drug treatment to the date of the first documented PD. PD is defined as increase of 25% of lowest response value in one or more of following criteria: serum M-component (absolute increase ≥0.5 g/dl); or urine M-component (absolute increase ≥200 mg/24-hour); difference between involved and uninvolved FLC levels (absolute increase \>10 mg/dl); or bone marrow plasma cell percentage (absolute plasma cell percentage ≥10%); development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma; or development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.

   Time frame: Up to 5 years

3. Overall Survival (OS)

   OS is defined as the time from the date of first dose of any study drug treatment to the date of death. Participant without documentation of death at the time of analysis will be censored at the last visit at which s/he was known to be alive.

   Time frame: Up to 5 years

4. Overall Response Rate (ORR)

   ORR is defined as percentage of participants with complete response (CR), VGPR and partial response (PR). CR: Negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow; normal free light chain (FLC) ratio of 0.26-1.65; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum M-protein + urine M-protein level \<100 mg/24 hours; and PR: \>=50% reduction of serum M protein and reduction in 24-hour urinary M protein by \>=90%/to \<200 mg/24 hours; In addition, if present at baseline, \>=50% reduction in size of soft tissue plasmacytomas; no known evidence of progressive/new bone lesions. The percentage of participants were rounded off to the single decimal point.

   Time frame: Up to 5 years

5. Time To Response (TTR)

   TTR is defined as the time from first dose of any study drug treatment to the date of first documentation of PR or better. PR is defined as \>=50% reduction of serum M protein and reduction in 24-hour urinary M protein by \>=90%/to \<200 mg/24 hours; In addition, if present at baseline, \>=50% reduction in size of soft tissue plasmacytomas; no known evidence of progressive/new bone lesions.

   Time frame: Up to 5 years

6. Duration of Response (DOR)

   DOR is defined as the time from the date of first documentation of PR or better to the date of the first documented PD among participants who responded to the treatment.

   Time frame: Up to 5 years

Baseline characteristics

Study documents

• Study protocol · Mar 30, 2022
• Statistical analysis plan · Nov 6, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement

Supporting information: Study protocol, Sap, Icf, Csr