UARK 98-026 TT II: Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy

Browse trials for

• Multiple Myeloma 3,632
• Neoplasms, Plasma Cell 2,306

Keywords

• Multiple Myeloma
• Cancer
• Therapy
• Thalidomide
• DTPACE
• Transplant
• VAD
• DCEP
• CAD
• Consolidation
• Melphalan

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 668 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Lead sponsor

University of Arkansas is the lead sponsor of 391 studies on the registry; 39 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.

Study arms

• Active comparator
  Thalidomide

  Thalidomide 400 qod during induction.100 mg qd between transplants, post transplant pat. 200 mg qd. During year one of maintenance therapy pt will take 100mg of Thal qod and 50 mg of thal qod during second year of maintenance

  Drug: Thalidomide · Drug: Ara-C · Drug: BCNU · Drug: Cisplatin · Drug: Cytoxan · Drug: Dexamethasone · Drug: Etoposide · Drug: Filgrastim · Drug: Recombinant GM-CSF · Drug: Interferon-alpha-2b · Drug: Melphalan

• Active comparator
  No Thalidomide

  During induction, consolidation, and maintenance steps patient receives no thalidamide

  Drug: Ara-C · Drug: BCNU · Drug: Cisplatin · Drug: Cytoxan · Drug: Dexamethasone · Drug: Doxorubicin · Drug: Etoposide · Drug: Filgrastim · Drug: Recombinant GM-CSF · Drug: Interferon-alpha-2b · Drug: Melphalan · Drug: Vincristine

Interventions

• DrugThalidomide

  All patients will be randomly assigned to receive thalidomide 400 mg as an oral, once daily dose throughout induction and 100mg between transplants after platelets are greater than 50,000μl and 200 mg post transplant consolidation, and a reduced dose of 100 mg on alternating days during the first year of maintenance and 50 mg qod thereafter versus no thalidomide. Thalidomide will be held during conditioning, transplant procedure, and recovery following transplant. It may be resumed once plateletrecovery is complete after each transplant

  Also known as: Thalomid

• DrugAra-C

  Cytarabine (Ara-C) 400 mg/m2 in 250 ml D5W over one hour daily for four days (on days -5, -4, -3, -2). Start infusion 30 minutes after completion of BCNU on day -5.

  Also known as: Cytarabine

• DrugBCNU

  Carmustine (BCNU) 300 mg/m2 in 1 liter of D5W in glass bottle (protect from light) to infuse over 2 hours on day -5. Check blood pressure every 15 minutes during infusion and 30 minutes after completion

  Also known as: Carmustine

• DrugCisplatin

  Cisplatin\* 15 mg/m2/day Continuous infusion 1-4 (DCEP CYCLE 2) Cisplatin\* 7.5 mg/m2 Continuous infusion 1-4 (DPACE cycle) \*Cisplatin doses will be modified for renal insufficiency as follows: Cisplatin dose Creatinine 15 mg/m2 (full dose) \< 1.5 mg/dl 10 mg/m2 1.6 - 2.0 mg/dl 7.5 mg/m2 2.1 - 3.0 mg/dl 0 mg (hold Cisplatin) \> 3.0 mg/dl

  Also known as: cisplatinum, cis-diamminedichloroplatinum, Platinol, Platinol-AQ

• DrugCytoxan

  Cycle 2 - DCEP Cyclophosphamide 400 mg/m2/day Continuous infusion 1-4 Cycle 3 - CAD and PBSC Collection #1 Cyclophosphamide 750 mg/m2/day Continuous infusion 1-4 Cycle 4 - DCEP Cyclophosphamide 400 mg/m2/day Continuous infusion 1-4 Cytoxan/VP-16 and PBSC Collection-Cyclophosphamide 2 grams/m2 (Total dose 4 gm/m2) IV by CI 1 and 2 Post-Transplant Consolidation-Cyclophosphamide 300 mg/m2 Continuous infusion 1-4

  Also known as: Cyclophosphamide, Endoxan, Neosar, Procytox, Revimmune, cytophosphane

• DrugDexamethasone

  Induction cycle 1 VAD Dexamethasone 40 mg/day PO 1-4, 9-12, 17-20 Cycle 2 - DCEP Dexamethasone 40 mg/day PO 1-4 Cycle 3 - CAD and PBSC Collection #1 Dexamethasone 40 mg/day PO 1-4 Cycle 4 - DCEP and PBSC Collection #2 Dexamethasone 40 mg/day PO 1-4 Post-Transplant Consolidation Dexamethasone 40 mg PO 1-4 Dexamethasone Consolidation Patients that do not achieve adequate platelet recovery (defined as \< 80,000/μl) will receive consolidation with Dexamethasone 40 mg x 4 days every 28 days for 1 year Maintenance year one Dexamethasone 40 mg PO q 3 months, day 1-4, 9-12, 17-20

  Also known as: Tobradex

• DrugDoxorubicin

  Doxorubicin may be further diluted in 5% dextrose or sodium chloride injection and should be administered slowly into tubing of a freely flowing intravenous infusion with great care taken to avoid extravasation.

  Also known as: Adriamycin, hydroxydaunorubicin

• DrugEtoposide

  Etoposide (VP16) 200 mg/m2 in 500 ml D5W over one hour daily for four days (on days -5, -4, -3, -2). Start infusion 30 minutes after completion of BCNU on day -5. Start infusion at completion of cytarabine on following three days

  Also known as: Eposin, Etopophos, Vepesid, VP-16

• DrugFilgrastim

  G-CSF will be administered at a dose of 10mcg/kg or GM-CSF at a dose of 10 mcg/kg. G-CSF or GM-CSF will begin one day after completion of chemotherapy and continued during repeated apheresis and discontinued upon completion of apheresis.

  Also known as: Neupogen, Grafeel, Religrast, Nugraf, Shilgrast, Neukine, Emgrast

• DrugRecombinant GM-CSF

  GM-CSF at a dose of 10 μg/kg SC, divided in 2 doses each day, will begin one day after completion of chemotherapy and continued during repeated apheresis and discontinued upon completion of apheresis.

• DrugInterferon-alpha-2b

  AGENT DOSE ROUTE DAYS Intron-A 3 million units/m2 SQ TIW Thalidomide (for those randomized at initial registration) 50 mg QOD PO Every other day (qod

• DrugMelphalan

  Etoposide (VP16) 200 mg/m2 in 500 ml D5W over one hour daily for four days (on days -5, -4, -3, -2). Start infusion 30 minutes after completion of BCNU on day -5. Start infusion at completion of cytarabine on following three days

  Also known as: Alkeran

• DrugVincristine

  Formulation: 1 mg/1 ml, 2 mg/2 ml, and 5 mg/ 5 ml vials. Vincristine should be administered intravenously through a freely-running IV. If it extravasates, it produces a severe local reaction with skin slough. FATAL IF GIVEN INTRATHECALLY, FOR INTRAVENOUS USE ONLY.

  Also known as: Oncovin, leurocristine

Primary outcomes

1. Overall Survival

   Overall Survival at six years after initiating protocol therapy

   Time frame: 6 Years

Baseline characteristics

Publications

• Barlogie B, Tricot G, Anaissie E, Shaughnessy J, Rasmussen E, van Rhee F, Fassas A, Zangari M, Hollmig K, Pineda-Roman M, Lee C, Talamo G, Thertulien R, Kiwan E, Krishna S, Fox M, Crowley J. Thalidomide and hematopoietic-cell transplantation for multiple myeloma. N Engl J Med. 2006 Mar 9;354(10):1021-30. doi: 10.1056/NEJMoa053583. PubMed 16525139 ↗
• Vatsveen TK, Sponaas AM, Tian E, Zhang Q, Misund K, Sundan A, Borset M, Waage A, Brede G. Erythropoietin (EPO)-receptor signaling induces cell death of primary myeloma cells in vitro. J Hematol Oncol. 2016 Aug 31;9(1):75. doi: 10.1186/s13045-016-0306-x. PubMed 27581518 ↗
• Usmani SZ, Heuck C, Mitchell A, Szymonifka J, Nair B, Hoering A, Alsayed Y, Waheed S, Haider S, Restrepo A, Van Rhee F, Crowley J, Barlogie B. Extramedullary disease portends poor prognosis in multiple myeloma and is over-represented in high-risk disease even in the era of novel agents. Haematologica. 2012 Nov;97(11):1761-7. doi: 10.3324/haematol.2012.065698. Epub 2012 Jun 11. PubMed 22689675 ↗

Related links

• Myeloma Institute for Research \& Therapy website ↗