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

Inclusion criteria

• 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.
• Age 18 years or older
• Life expectancy of at least six months
• Patients have to give written informed consent (which must be consistent with ICH-GCP and local legislation)
• Eastern Cooperative Oncology Group (ECOG) performance score <2.
• Recovery from all therapy-related toxicities from previous chemo-, immuno- or radiotherapies.

Exclusion criteria

• 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
• Active infectious disease
• Uncontrolled, severe hypertension
• Gastrointestinal disorders anticipated to interfere with the resorption of the study drug
• Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
• Absolute neutrophil count less than 1000 / mm³.
• Platelet count less than 30 000 / mm³
• Conjugated Bilirubin greater than 2 mg / dl (> 34 μmol/L, SI unit equivalent)
• Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than three times the upper limit of normal
• Endogenous creatinine clearance (ECC) <20 ml/min
• Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
• Pregnancy or breastfeeding
• 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)
• Patients unable to comply with the protocol
• Active alcohol or drug abuse