Phase 2
N=58
Combination Plerixafor (AMD3100)and Bortezomib in Relapsed or Relapsed/Refractory Multiple Myeloma
Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT00903968 ↗Enrolled (actual)
58
Serious AEs
36.1%
Results posted
Sep 2017
Primary outcome: Primary: Plerixafor Maximum Tolerated Dose (MTD) [Phase I] — 320 ug/kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Plerixafor (Drug); bortezomib (Drug); Dexamethasone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plerixafor Maximum Tolerated Dose (MTD) [Phase I] |
320 | — |
| PRIMARY Bortezomib Maximum Tolerated Dose (MTD) [Phase I] |
1.3 | — |
| PRIMARY Number of Participants With Dose Limiting Toxicity (DLT) [Phase I] |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Response Rate of Plerixafor, Bortezomib, and Dexamethasone in Relapsed or Relapsed/ Refractory Multiple Myeloma (ORR) [Phase I and Phase II] |
0; 0; 1; 0; 0; 0 | — |
| SECONDARY Time to Progression (TTP) [Phase II] |
12.6 | — |
| SECONDARY Duration of Response (DOR) [Phase II] |
12.9 | — |
Summary
The purpose of this research study is to determine the safety of plerixafor and bortezomib, and the highest dose that can be given to people safely. Plerixafor appears to stop myeloma cells from attaching to bone marrow and has been used in other phase I studies for mobilization of stem cells for patients with myeloma and lymphoma. We have shown that the combination of plerixafor and bortezomib is very effective in killing myeloma cells in the laboratory more than the effect of each drug alone.
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- Must have received prior 1-5 therapies for their myeloma and have relapsed or refractory multiple myeloma. Prior therapy with bortezomib is allowed as long as they were not refractory to bortezomib
- Monoclonal protein serum of 1gm/dL or greater or monoclonal light chain in the urine protein electrophoresis of 200 mg/24 hours or greater, or measurable light chains by free light chain assay of 10 mg/dL or greater, or measurable plasmacytoma
- ECOG Performance Status 0, 1, or 2
- Laboratory values as outlined in the protocol
Exclusion Criteria
- Uncontrolled infection
- Cytotoxic chemotherapy < 3 weeks, or biologic or targeted novel therapy < 2 weeks, or corticosteroids < 2 weeks prior to registration. Patients may be receiving chronic corticosteroids if they are being given for disorders other than myeloma
- Pregnant women
- Nursing women
- Men or women of child-bearing potential who are unwilling to employ adequate contraception
- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational
- Known to be HIV positive
- Radiation therapy < 2 weeks prior to registration
Data sourced from ClinicalTrials.gov (NCT00903968). 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.