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Proteasome Inhibitor

Schedule I (dinaciclib, bortezomib, dexamethasone) for Multiple Myeloma

Phase 1
Waitlist Available
Led By Shaji Kumar
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights
Approved for 60 Other Conditions
No Placebo-Only Group

Summary

This phase I trial studies the side effects and best dose of dinaciclib and bortezomib when given together with dexamethasone in treating patients with multiple myeloma that has returned after a period of improvement. Dinaciclib and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving dinaciclib and bortezomib together with dexamethasone may kill more cancer cells.

Eligible Conditions
  • Multiple Myeloma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
MTD of dinaciclib and bortezomib when given together with dexamethasone, based on the incidence of dose-limiting toxicity (DLT), graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Secondary study objectives
Incidence of adverse events, graded according to NCT CTCAE version 4.0
Overall response rate
Time to progression
+2 more

Awards & Highlights

Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Schedule II (dinaciclib, bortezomib, dexamethasone)Experimental Treatment4 Interventions
Patients receive dinaciclib IV over 2 hours on day 1; bortezomib SC on days 1 and 8; and dexamethasone PO QD on days 1, 2, 8, and 9. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group II: Schedule I (dinaciclib, bortezomib, dexamethasone)Experimental Treatment4 Interventions
Patients receive dinaciclib IV over 2 hours and bortezomib SC or IV (if patients do not tolerate SC injection) on days 1, 8, and 15 and dexamethasone PO QD on days 1, 2, 8, 9, 15, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bortezomib D-mannitol
FDA approved
Dexamethasone
FDA approved
Dinaciclib
Not yet FDA approved

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,928 Previous Clinical Trials
41,018,098 Total Patients Enrolled
594 Trials studying Multiple Myeloma
191,405 Patients Enrolled for Multiple Myeloma
Shaji KumarPrincipal InvestigatorMayo Clinic
15 Previous Clinical Trials
1,711 Total Patients Enrolled
15 Trials studying Multiple Myeloma
1,711 Patients Enrolled for Multiple Myeloma
~3 spots leftby Nov 2025
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