A Phase II Study of Dasatinib in the Treatment of Relapsed or Plateau Phase Multiple Myeloma

NCT00429949 | Completed Phase 2 Results

• 1 other identifier: 06-1159
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the response rate (Complete Response \[CR\] and Partial Response \[PR\]) to dasatinib in patients with relapsed, refractory or plateau phase multiple myeloma whose serum paraprotein levels are \>0.5g/dL or urine paraprotein levels are \>1.0g/24 hours.

Conditions

Relapsed, Refractory or Plateau Phase Multiple Myeloma

Keywords

Dasatinib; Plateau phase

Outcome Measures

Primary Outcomes (1)

• Response Rate [Complete Response (CR) and Partial Response (PR)]

  CR requires all of the following: * Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune response reconstitution does not exclude CR. * \< 5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy, if biopsy is performed. If absence of monoclonal protein is sustained for 6 weeks it is not necessary to repeat the bone marrow. * No increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response). * Disappearance of soft tissue plasmacytoma PR requires all of the following: * 50% reduction in the level of the serum monoclonal paraprotein maintained for a minimum of 6 weeks. -Reduction in 24 hr urinary light chain excretion by either \> 90% or to \< 200 mg, maintained for a minimum of 6 weeks. * 50% reduction in the size of soft tissue plas

  Completion of treatment (median duration of therapy was 51 days)

Secondary Outcomes (5)

• Time to Response

  Completion of treatment (median duration of therapy was 51 days)

• Safety and Tolerability of Dasatinib (Grade III-IV Toxicities)

  Up to 30 days following end of treatment (median duration of therapy was 51 days)

• Duration of Response

  Completion of treatment (median duration of therapy was 51 days)

• Event-free Survival (EFS) for Participants With Plateau Phase Disease

  Completion of treatment (median duration of therapy was 51 days)

• Event-free Survival (EFS) for Participants With Relapsed Disease

  Completion of treatment (median duration of therapy was 51 days)

Study Arms (1)

Dasatinib

EXPERIMENTAL

Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle. In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle.

Drug: Dasatinib

Interventions

Dasatinib DRUG

Also known as: Sprycel

Dasatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Multiple myeloma diagnosed by standard criteria with either relapsed or plateau-phase disease.
• Relapsed: At least 1 prior therapy for multiple myeloma with documented evidence of progression on the most recent treatment.
• Plateau-phase: subjects with myeloma who had a response to their most recent multiple myeloma therapy (including autologous transplantation or other investigational agents) and have residual detectable monoclonal protein in their serum or urine that has been stable for greater than or equal to 3 months (+/- 25% change in M-protein).
• Measurable levels of monoclonal protein in serum (greater than or equal to 0.5 g/dL) or urine (greater than or equal to 1.0 g/24 hr).
• Age 18 years or older.
• ECOG performance status of less than or equal to 2.
• Acceptable organ and marrow function as defined below:
• Hemoglobin of greater than or equal to 8 gm/dL
• Absolute neutrophil count of greater than or equal to 500/mm3
• Platelets of greater than or equal to 50,000/mm3
• PT and PTT of less than or equal to 1.5 times the institutional Upper Limit of Normal (ULN)
• Total bilirubin of less than or equal to 2.0 times the institutional ULN institutional ULN
• Hepatic enzymes (AST, ALT ) equal to 2.5 times the institutional ULN
• Serum Na, K+, Mg2+, Phosphate and Ca2+ greater than or equal to Lower Limit of Normal (LLN)
• Serum Creatinine of less than or equal to 1.5 times the institutional ULN

You may not qualify if:

• Receiving any of the following therapies or medications:
• Any investigational agents within 30 days.
• Drugs that are generally accepted to have a risk of causing Torsade de Pointes including:
• quinidine, procainamide, disopyramide
• amiodarone, sotalol, ibutilide, dofetilide
• erythromycin, clarithromycin
• chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide
• cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone,
• halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
• Subjects who have discontinued any of these medications must have a wash-out period of at least 7 days prior to the first dose of dasatinib.
• Medications known to be potent CYP3A4 inhibitors (See Appendix D).
• The concomitant use of H2 blockers or proton pump inhibitors with dasatinib is not recommended. The use of antacids should be considered in place of H2 blockers or proton pump inhibitors in patients receiving dasatinib therapy (See section 5.5.2.3 for important cautions regarding use of antacids.)
• Patient agrees to discontinue St. Johns Wort while receiving dasatinib therapy.
• Patient agrees that IV bisphosphonates will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia.
• Prior therapy with dasatinib

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington Universtiy in St. Louis

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Recurrence

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Ravi Vij, M.D.
• Organization: Washington University School of Medicine

rvij@dom.wustl.edu

314-454-8304

Study Officials

• Ravi Vij, M.D.

  Washington Universtiy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2007
• First Posted: February 1, 2007
• Study Start: January 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: August 29, 2014
• Results First Posted: August 29, 2014

Record last verified: 2014-08

Locations

US (1)