Daratumumab(HuMax®-CD38)Safety Study in Multiple Myeloma
Phase: Phase 1/Phase 2
Diagnosis: Multiple Myeloma
NCT ID: NCT00574288
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 10-429
Establishment of safety profile of HuMax-CD38 when given as monotherapy in patients with multiple myeloma relapsed or refractory to at least 2 different cytoreductive therapies and without further established treatment options.
Dana-Farber Cancer Institute, Brigham and Women's Hospital
Jacob Laubach, MD,
Dana-Farber Cancer Institute
Dana-Farber Cancer Institute:
Stacey Chuma, 617-632-4863,
1. Diagnosis of MM requiring systemic therapy (34): 2. Age ≥ 18 years. 3. ECOG
performance status (0-2). 4. Life expectancy > 3 months. 5. Relapsed or refractory to two
or more different prior therapies, Exclusion criteria
1. Plasma cell leukemia .
2. Known amyloidosis
3. Patients who previously have received an allogeneic stem cell transplant and receive
or have received immunosuppressive therapy within the last three months.
Patients who previously have received an allogeneic stem cell transplant and have
signs of acute or chronic graft-versus-host disease.
4. Sensory or motor neuropathy ≥ grade 3.
5. Past or current malignancy,
6. Chronic or ongoing active infectious disease
7. Clinically significant cardiac disease
8. Significant concurrent, uncontrolled medical condition including, but not limited to,
renal (except related to MM), hepatic, hematological except MM, gastrointestinal,
endocrine, pulmonary, neurological, cerebral or psychiatric disease.
9. Patients with baseline QTcF > 470 ms, as well as those with complete left bundle
branch block (defined as a QRS ≥ 120 ms in left bundle branch block form).
11. Clinical signs of meningeal involvement of MM.
12. Known severe chronic obstructive pulmonary disease or asthma defined as FEV1< 60% of
13. History of significant cerebrovascular disease.
14. Known Human Immunodeficiency Virus seropositivity.
15. Positive serology for hepatitis B
16. Screening laboratory values
17. Concomitant corticosteroid
18. Other chemotherapy that is or may be active against myeloma within 3 weeks prior to