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A Phase I/II Study of hLL1-DOX (Milatuzumab-Doxorubicin Antibody-Drug Conjugate) in Patients With Multiple Myeloma

Phase 1/Phase 2
18 Years
Not Enrolling
Multiple Myeloma

Thank you

Trial Information

A Phase I/II Study of hLL1-DOX (Milatuzumab-Doxorubicin Antibody-Drug Conjugate) in Patients With Multiple Myeloma

In this clinical research trial, hLL1-DOX will be administered on days 1, 4, 8 and 11. This
treatment cycle will be repeated every 3 weeks as long as patients continue to tolerate it,
for a maximum of 8 treatment cycles (approximately 6 months).

Inclusion Criteria:

- Able to provide signed, informed consent;

- Male or female, >/= 18 years old;

- Multiple myeloma with one or more criteria for measurable disease (serum M protein >
0.5 gm/dl, urinary M protein excretion > 200 mg/24 hours, serum free light chain
measurement >20 mg/dl,);

- Refractory or relapsed to at least two prior standard systemic anti-myeloma treatment
regimens one of which must include either thalidomide, lenalidomide or bortezomib;

- Adequate performance status (Karnofsky Scale >/= 70%);

- Life expectancy at least 6 months;

- Adequate cardiac function: MUGA scan or 2D-ECHO with LVEF 55%, EKG with no
medically relevant arrhythmia uncontrolled on medications;

- Adequate hematologic status within 2 weeks before study drug administration:

- Hemoglobin >/=8.0 g/dL and platelets >/=75,000/mm3 (both without transfusion or other
hematologic support within 7 days of laboratory testing)

- White blood count (WBC) >/= 2,000/mm3and absolute neutrophil count (ANC) >/=1,500/mm3
(both without the use of colony stimulating factors within 7 days of laboratory

- Adequate renal function: serum creatinine
- Adequate hepatic function

- AST and ALT
- Total bilirubin
Exclusion Criteria:

- 1. Pregnant or lactating women. Women of childbearing potential must have a negative
pregnancy test Pregnancy testing is not required for post-menopausal or surgically
sterilized women;

- Patients who are eligible for stem cell transplant.

- Women of childbearing potential and fertile men who are not practicing or who are
unwilling to practice birth control while enrolled in the study until at least 12
weeks after the last hLL1-dox infusion;

- Prior local radiotherapy within 14 days; chemotherapy or kyphoplasty within 21 days,
immunotherapy, plasmapheresis, or major surgery within 28 days; prior stem cell
transplant within 12 weeks.

- Must have no persistent ≥ Grade 2 toxicity from prior treatments;

- Prior treatment with any other therapeutic agents for MM or investigational agents
within 4 weeks, unless off study, and agreed by Sponsor;

- A history of allergic or adverse reactions to anthracycline/anthracenedione agents;

- Cumulative life-time anthracycline/anthracenedione exposure exceeding 300 mg/m2
(including daunorubicin, idarubicin, epirubicin or mitoxantrone);

- Known to be HIV positive, or any prior hepatitis B or C infection;

- Any history of clinically significant autoimmune disease (e.g., collagen vascular
disorders, autoimmune hepatitis, Coombs positive anemia/thrombocytopenia, etc.)

- Prior history of mediastinal or pericardial external beam radiation therapy.

- Prior history of treatment with trastuzumab, unless discussed with and agreed to by
Medical Monitor.

- Systemic infection or requiring anti-infectives within 7 days before first dose of
study drug;

- Substance abuse or other concurrent medical conditions that, in the Investigator's
opinion, could confound study interpretation or affect the patient's ability to
tolerate or complete the study.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

Safety evaluations include monitoring for infusion reactions or other acute adverse events, cardiac assessments (EKG, troponin T, BNP, MUGA scan or 2D-ECHO), vital signs, physical examination, routine safety laboratories (hematology, serum chemistries, urinalysis), serum immunoglobulins, and B- and T-cell levels, with immunogenicity analyzed by the Sponsor from human anti-milatuzumab antibody serum titers (HAHA). Antibody pharmacokinetics will be evaluated by hLL1-DOX serum levels analyzed by the Sponsor.

Outcome Time Frame:

Safety is measured during the treatment period and for a minimum of 12 weeks after the treatment period for a maximum of 2 years.

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

July 2010

Completion Date:

June 2015

Related Keywords:

  • Multiple Myeloma
  • Treatment
  • Multiple Myeloma
  • Relapsed, refractory multiple myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Hackensack University Medical CenterHackensack, New Jersey  07601
Georgia Cancer SpecialistsDecatur, Georgia  30033
University Hospital of PennsylvaniaPhiladelphia, Pennsylvania  19104
MD Anderson OrlandoOrlando, Florida  32806
MD Anderson CenterHouston, Texas  77030