A Phase I/II Study of BI-505 in Conjunction With Autologous Stem Cell Transplant in Multiple Myeloma

B

BioInvent International

Status and phase

Terminated
Phase 2
Phase 1

Conditions

Multiple Myeloma

Treatments

Biological: BI-505
Other: High dose melphalan
Other: Autologous stem cell transplantation

Study type

Interventional

Funder types

Industry

Identifiers

NCT02756728
15-BI-505-03

Details and patient eligibility

About

The purpose of this study is to investigate the safety and efficacy of administering BI-505 in conjunction with high dose melphalan and stem cell transplantation in multiple myeloma patients.

Full description

N/A study is closed

Enrollment

5 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • A diagnosis of multiple myeloma by 2014 IMWG criteria and have been recommended to undergo HDM + ASCT as a standard-of-care therapy for their multiple myeloma.
  • Subjects must have adequate vital organ function and functional status for HDM + ASCT
  • Subjects must have collected and cryopreserved ≥4x106 hematopoietic stem cells per kg of actual body weight that are suitable for use in autologous stem cell transplantation in the judgment of the investigator.
  • At the time of enrollment, subjects must have had at least a partial response, as defined by IMWG criteria and in comparison to baseline/pre-treatment parameters, to an induction regimen containing lenalidomide and/or bortezomib.

Subjects must have measurable disease according to one of the following criteria:

  • Serum M-spike ≥0.1 g/dl
  • Urine M-spike >200 mg in a 24-hour urine collection
  • Involved serum free light chain above the upper limit of normal and a serum free light chain ratio outside the normal range.
  • At the time of enrollment, subjects must be within 12 months of the first dose of initial/induction therapy, and the anticipated day of ASCT must be within 12 months of the first dose of initial/induction therapy

Exclusion criteria

  • Prior allogeneic or autologous hematopoietic stem cell transplant
  • Current active infections, including HIV and hepatitis C and B
  • Autoimmune disease requiring ongoing immunosuppressive therapy.
  • History of atrial fibrillation or flutter, including paroxysmal atrial fibrillation or flutter.
  • History of transient ischemic attack or stroke.
  • At the time of enrollment, subjects must not have required multi-agent continuous-infusion cytotoxic chemotherapy (e.g., regimens such as D-PACE) as part of their initial/induction therapy.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

5 participants in 2 patient groups

HDM+ASCT
Active Comparator group
Description:
Standard of care; High dose Melphalan + Autologous Stem Cell Transplantation
Treatment:
Other: Autologous stem cell transplantation
Other: High dose melphalan
BI-505
Experimental group
Description:
Biweekly infusions of BI-505 in addition to High dose Melphalan + Autologous Stem Cell Transplantation
Treatment:
Other: Autologous stem cell transplantation
Other: High dose melphalan
Biological: BI-505

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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