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Phase 2 N=32 Treatment

Ixazomib Plus Pomalidomide and Dexamethasone in Treating Patients With Relapsed or Relapsed/Refractory Multiple Myeloma

Refractory Plasma Cell Myeloma · Recurrent Plasma Cell Myeloma

Enrolled (actual)
32
Serious AEs
46.9%
Results posted
Sep 2021
Primary outcome: Primary: Number of Patients With Dose-Limiting Toxicities (Phase I) — 1; 1 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
ixazomib citrate (Drug); dexamethasone (Drug); pomalidomide (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
City of Hope Medical Center
Primary completion
May 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Patients With Dose-Limiting Toxicities (Phase I)
1; 1
PRIMARY
Overall Response Rate at the Recommended Phase II Dose (RP2D)
48
PRIMARY
Maximum Tolerated Dose (MTD) of MLN9708 (Phase I)
4
SECONDARY
Duration of Response at the Recommended Phase II Dose (RP2D)
9.2
SECONDARY
Clinical Benefit Response Rate at the Recommended Phase II Dose (RP2D)
76
SECONDARY
One-Year Overall Survival at the Recommended Phase II Dose (RP2D)
82
SECONDARY
One-Year Progression-Free Survival at the Recommend Phase II Dose (RP2D)
34

Summary

This phase I/II trial studies the side effects and best dose of ixazomib and to see how well it works when given together with pomalidomide and dexamethasone in treating patients with relapsed or relapsed/refractory multiple myeloma. Ixazomib may stop the growth of cancer by interfering with proteasomes (the protein breakdown mechanism in the cells). Pomalidomide and dexamethasone can modify and regulate the immune system and may stop cancer cells from growing. Giving ixazomib with pomalidomide and dexamethasone may be an effective treatment for relapsed or relapsed/refractory multiple myeloma.

Eligibility Criteria

Inclusion Criteria

  • 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of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
  • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days prior to and again within 24 hours of starting pomalidomide or MLN9708 and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide or MLN9708 through 90 days after the last dose of study drug; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy from the time of signing the informed consent form through 90 days after the last dose of study drug; all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure
  • All patients enrolled into this trial, must be registered in and must comply with all requirements of the POMALYST (pomalidomide) Risk Evaluation and Mitigation Strategy (REMS) program
  • Patients must have a diagnosis of relapsed or relapsed and refractory multiple myeloma with a minimum of one prior regimen and a maximum of 5 prior regimens
  • Patients must have had therapy with a proteasome inhibitor and lenalidomide and be refractory to lenalidomide according to the International Myeloma Working Group (IMWG) criteria definition of refractory disease (progressive disease on or within 60 days of stopping lenalidomide)
  • Patients must have measurable disease defined as one of the following:
  • Serum M protein >= 0.5 g/dL
  • Urine M protein >= 200 mg/24 hours
  • Serum free light chain >= 10 mg/dL provided the free light chain (FLC) ratio is abnormal
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
  • Absolute neutrophil count (ANC) >= 1,000/mm^3
  • Platelet count >= 75, 000/uL for patients in whom = 50,000/uL for patients in whom >= 50% of bone marrow nucleated cells are plasma cells; platelet transfusions are not allowed within 3 days of last platelet assessment to confirm eligibility
  • Total bilirubin = = 45 mL/min

Exclusion Criteria

  • Female patients who are pregnant or breastfeeding or have a positive serum pregnancy test during the screening period
  • Failure to have fully recovered (ie, = grade 2 peripheral neuropathy on clinical examination during the screening period
  • Participation in other clinical trials, including those with other investigational agents not included in this trial, within 21 days of the start of this trial and throughout the duration of this trial (for all other standard therapies, no treatment within 14 days of the start of this trial)
  • Patients who are pomalidomide refractory, defined as patients who progress on or within 60 days of pomalidomide when given as a single agent or with dexamethasone
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02119468). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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