Overview

An Dose Escalation Study of BIBF 1120 Administered in Patients With Relapsed or Refractory Multiple Myeloma

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
Maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of BIBF 1120, pharmacodynamics
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Boehringer Ingelheim
Treatments:
Nintedanib
Criteria
Inclusion Criteria:

1. Patients with confirmed diagnosis of multiple myeloma, who did not respond to or
relapsed after either anthracyclines and pulsed glucocorticoids or high-dose therapy
and who are currently not eligible for transplant modalities.

2. Age 18 years or older

3. Life expectancy of at least six months

4. Patients have to give written informed consent (which must be consistent with ICH-GCP
and local legislation)

5. Eastern Cooperative Oncology Group (ECOG) performance score <2.

6. Recovery from all therapy-related toxicities from previous chemo-, immuno- or
radiotherapies.

Exclusion Criteria:

1. History of relevant surgical procedures during the last four weeks prior to treatment
with the trial drug, or active ulcers, fractures or injuries with incomplete healing

2. Active infectious disease

3. Uncontrolled, severe hypertension

4. Gastrointestinal disorders anticipated to interfere with the resorption of the study
drug

5. Serious illness or concomitant non-oncological disease considered by the investigator
to be incompatible with the protocol

6. Absolute neutrophil count less than 1000 / mm³.

7. Platelet count less than 30 000 / mm³

8. Conjugated Bilirubin greater than 2 mg / dl (> 34 μmol/L, SI unit equivalent)

9. Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater
than three times the upper limit of normal

10. Endogenous creatinine clearance (ECC) <20 ml/min

11. Women and men who are sexually active and unwilling to use a medically acceptable
method of contraception

12. Pregnancy or breastfeeding

13. Treatment with other investigational drugs or participation in another clinical trial
within the past four weeks before start of therapy or concomitantly with this trial
(except for present trial drug)

14. Patients unable to comply with the protocol

15. Active alcohol or drug abuse