Lenalidomide & High Dose Dexamethasone for Untreated Multiple Myeloma Renal Failure Patients

NCT01270932 | Completed Phase 2 DMC

• 1 other identifier: RV-MM-PI-0505
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Primary:

• To validate the initial dosing recommendations for newly diagnosed MM (Mutiple Myeloma) patients with various degrees of renal failure using pharmacokinetic studies Secondary:
• To evaluate the safety of lenalidomide and dexamethasone as induction therapy in newly-diagnosed MM (Multiple Myeloma) patients with renal dysfunction using modified dosing guidelines
• To evaluate clinical response of lenalidomide and dexamethasone after 4 cycles using the modified dosing guidelines
• To evaluate the ability to collect stem cells after 4 cycles of lenalidomide and dexamethasone induction therapy in MM (Multiple Myeloma) patients with renal failure

Conditions

Renal Failure; Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Serum Pharmacokinetic (PK) analysis of Study drug Lenalidomide

  PK data will be analyzed and reported after completion of PK studies in all patients

  16 months

Secondary Outcomes (3)

• Evaluable for toxicity

  5 months

• Evaluable for response

  5 months

• Overall and progression free survival rates which will be calculated by the method of Kaplan and Meier.

  16 months

Study Arms (1)

Lenalidomide and Dexamethasone

EXPERIMENTAL

Lenalidomide:Daily for 21 days of a 28 day cycle Dexamethasone:Days 1-4, 9-12, 17-20 for the first cycle and then weekly dexamethasone from cycles 2-4.

Drug: Lenalidomide and Dexamethasone

Interventions

Lenalidomide and Dexamethasone DRUG

Lenalidomide:Daily for 21 days of a 28 day cycle Dexamethasone:Days 1-4, 9-12, 17-20 for the first cycle and then weekly dexamethasone from cycles 2-4.

Also known as: Revlimid for Lenalidomide, Decadron for Dexamethasone

Lenalidomide and Dexamethasone

Eligibility Criteria

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

You may not qualify if:

• Patients must fulfill all of the following criteria to be eligible for admission to the study:
• Understand and voluntarily sign an informed consent form
• Age≥18 years at the time of signing the informed consent form.
• Able to adhere to the study visit schedule and other protocol requirements.
• Previously untreated, symptomatic multiple myeloma as defined by ALL 3 criteria below:
• Monoclonal plasma cells in the bone marrow ≥10% and/or presence of a biopsy-proven plasmacytoma
• Monoclonal protein present in the serum and/or urine
• Myeloma-related organ dysfunction (at least one of the following):
• C - Calcium elevation in blood (serum calcium \>upper limit of normal) R - Renal insufficiency (serum creatinine \>177umol/L) A - Anemia (hemoglobin \<100g/L or 20g/L below normal) B - Lytic bone lesions or osteoporosis
• Eligible for autologous stem cell transplantation as per Princess Margaret Hospital criteria.
• Disease measurable by serum or urine M (monoclonal) protein, free light chain assay, bone marrow plasmacytosis or plasmacytoma.
• No prior myeloma therapy (Exception: up to 480 mg of dexamethasone is allowed within the past 28 days, as well as palliative, localized radiation therapy, without the requirement of a washout period prior enrollment).
• ECOG (Eastern Cooperative Oncology Group) performance status of ≤ 2 at study entry.
• Laboratory test results within these ranges:
• Absolute neutrophil count ≥ 1,000/mm³

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network- Princess Margaret Hosptial

Toronto, Ontario, M5G2M9, Canada

Location

Related Publications (1)

• Chen CI, Cao Y, Trudel S, Reece DE, Kukreti V, Tiedemann R, Prica A, Paul H, Le LW, Levina O, Kakar S, Lau A, Chen H, Chen E. An open-label, pharmacokinetic study of lenalidomide and dexamethasone therapy in previously untreated multiple myeloma (MM) patients with various degrees of renal impairment - validation of official dosing guidelines. Leuk Lymphoma. 2020 Aug;61(8):1860-1868. doi: 10.1080/10428194.2020.1747064. Epub 2020 May 31.

  PMID: 32476520 DERIVED

MeSH Terms

Conditions

Renal Insufficiency; Multiple Myeloma

Interventions

Lenalidomide; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Design

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

Study Record Dates

• First Submitted: December 13, 2010
• First Posted: January 5, 2011
• Study Start: November 1, 2010
• Primary Completion: December 18, 2017
• Study Completion: December 18, 2017
• Last Updated: December 29, 2017

Record last verified: 2017-12

Locations

CA (1)