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

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:

  1. Serum M-spike ≥0.1 g/dl
  2. Urine M-spike >200 mg in a 24-hour urine collection
  3. 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