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Details for trial 16M-06-1

Description:	Phase I, Multi-Center, Open-Label, Dose Escalation Study of HuLuc63 (Humanized anti-CS1 Monoclonal IgG1 Antibody) in Subjects with Advanced Multiple Myeloma.
Status:	Closed
Randomized?	No

Researchers

Principal Investigator	Title
Ann Mohrbacher	M.D.

Data Management

Name	Title
Lori Vergara	R.N.
Yvonne Avila	D.M.
Rebecca Amezcua	R.N.

You may participate in this study if:

	Requirement
1	18 y/o and above.
2	Diagnosis of advanced multiple myeloma after at least 2 prior treatments.
3	Measurable disease. M component in serum at least 0.5 G/dL &/or urine (= 0.2 g in 24-hour sample).
4	Not eligible for stem cell or bone marrow transplant or have refused stem cell or BM transplant or have relapsed after autologous or allogeneic stem cell or BM transplant.
5	ECOG Performance Status 0-2.
6	ALT or AST 3.0 (or less) x ULN.
7	Total bilirubin 2.0 (or less) x ULN, (unless related to MM).
8	Serum creatinine 2.0 or less. (3.0 or less, if related to MM).
9	Absolute Neutrophil Count > 1000; Platelets 75,000 or higher; Hgb 8.0 or higher. No platelet transfusion within 72 hrs of screening platelet count.
10	Serum calcium (corrected for albumin) within normal. Treatment of hypercalcemia allowed & pt may enroll if hypercalcemia returns to normal with treatment.
11	Use of appropriate contraception where applicable.
12	If a woman of childbearing potential, must have negative pregnancy test within 48 hrs prior to 1st dose.
13	2-D ECHO or MUGA showing LVEF 45% or higher, within 30 days prior to 1st dose.
14	Signed Informed Consent (including HIPAA authorization).

You may not participate in this study if:

1	Life expectancy is less than 3 months.
2	Prior malignancy except for adequately treated basal cell carcinome or squamous cell carcinoma of the skin, cervical carcinoma-in-situ, or other malignacy from which patient has been disease-free for at least 5 yrs.
3	Plasma cell leukemia (active or prior).
4	Uncontrolled medical problems such as DM, CAD, HTN, unstable angina, arrhythmias, pulmonary, hepatic, & renal disease unless renal insufficiency due to MM (serum creat > 2.0).
5	Solitary bone or solitary extramedullary plasmacytoma as only evidence of plasma cell dyscrasia.
6	Corticosteroid, Velcade or other proteosome inhibitor, thalidomide, lenalidomide (Revlimid), or melphalan within 2 wks of 1st dose. Nitrogen mustard agents within 6 wks of 1st dose.
7	Investigational drug within 4 wks or 5 half-lives (whichever is greater) of 1st dose.
8	Stem cell or BM transplant within 12 wks prior to 1st dose.
9	Biological agents, including IV immune globulin (IVIG) & monoclonal antibodies within 4 wks of 1st dose.
10	Grade 2 neuropathy.
11	Symptomatic orthostatic hypotension.
12	Evidence of amyloidosis.
13	Known active infections requiring antibiotics, antivirals, or antifungals.
14	Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse follow-up evaluation.
15	Any condition that makes patient unsuitable for study participation.
16	Hypersensitivity to recombinant proteins or excipients in the investigational agent.

For further information on, or to sign up for this study, please contact the Clinical Investigation Support Office at (323) 865-0451 or the Principal Investigator noted above.