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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Immunomedics, Inc.
ClinicalTrials.gov Identifier:
NCT01101594
First received: March 11, 2010
Last updated: January 22, 2014
Last verified: January 2014

March 11, 2010
January 22, 2014
July 2010
July 2013   (final data collection date for primary outcome measure)
Safety [ 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. ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01101594 on ClinicalTrials.gov Archive Site
Efficacy [ Time Frame: Efficacy is measured during and after the study drug treament period for a maximum of 2 years. ] [ Designated as safety issue: No ]
Efficacy endpoints (treatment response, duration of response and time to progression) will be evaluated using the International Myeloma Working Group Response Criteria for multiple myeloma.
Same as current
Not Provided
Not Provided
 
A Study of hLL1-DOX (Milatuzumab-Doxorubicin Antibody-Drug Conjugate) in Patients With Multiple Myeloma
A Phase I/II Study of hLL1-DOX (Milatuzumab-Doxorubicin Antibody-Drug Conjugate) in Patients With Multiple Myeloma

This study is a Ph I trial to test the safety of the study drug, hLL1-DOX at different dose levels in patients with recurrent multiple myeloma. HLL1 is also known as milatuzumab and is attached to doxorubicin in this clinical trial.

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).

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
Drug: hLL1-DOX (the doxorubicin conjugate of milatuzumab)
hLL1-DOX will be administered intravenously (through a vein) on days 1, 4, 8 & 11 every 21 days for up to 8 treatment cycles. 4 different dose levels of hLL1-DOX will be studied for safety and tolerability.
Other Names:
  • hLL1-DOX
  • Milatuzumab-DOX
  • CD74-DOX
Experimental: hLL1-DOX
4 Different dose levels of hLL1-DOX will be studied in groups of 3-6 patients. Once an optimal dose has been found, up to additional 30 patients will be studied at that dose level.
Intervention: Drug: hLL1-DOX (the doxorubicin conjugate of milatuzumab)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
July 2013
July 2013   (final data collection date for primary outcome measure)

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 testing);
  • Adequate renal function: serum creatinine </+ 2.5 mg/mL;
  • Adequate hepatic function
  • AST and ALT </= 2.5 x the ULN
  • Total bilirubin </= 1.5 x the ULN

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01101594
IM-T-hLL1-DOX-01
No
Immunomedics, Inc.
Immunomedics, Inc.
Not Provided
Not Provided
Immunomedics, Inc.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP