Phase 2 N=77 Treatment

Combination Chemo, Peripheral Stem Cell Transplant, Biological Therapy, Pamidronate and Thalidomide for Multiple Myeloma

Multiple Myeloma and Plasma Cell Neoplasm

Bottom Line

View on ClinicalTrials.gov: NCT00004088 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2019

Primary outcome: Primary: Best Response Prior to Tandem Autologous Stem Cell Transplant — 1; 4; 62; 1 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: filgrastim (Biological); recombinant interferon alfa (Biological); busulfan (Drug); cyclophosphamide (Drug); melphalan (Drug); pamidronate disodium (Drug); thalidomide (Drug); peripheral blood stem cell transplantation (Procedure)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: City of Hope Medical Center
Primary completion: Jan 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Best Response Prior to Tandem Autologous Stem Cell Transplant	1; 4; 62; 1	—
PRIMARY Response After Tandem Autologous Stem Cell Transplant	27; 11; 24; 3	—
PRIMARY Three-year Overall Survival	0.662	—
PRIMARY Progression-free Survival	0.456	—
PRIMARY Best Response at 6 Months Post Tandem Autologous Stem Cell Transplant	18; 5; 29; 11	—
PRIMARY Best Response After Tandem Autologous Stem Cell Transplant and Maintenance	3; 1; 6; 6	—

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells. Biological therapies, such as interferon alfa, use different ways to stimulate the immune system and stop cancer cells from growing. Thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor. Pamidronate may help to reduce the side effects of treatment for multiple myeloma. PURPOSE: This phase II trial is studying combination chemotherapy, peripheral stem cell transplantation, biological therapy, pamidronate, and thalidomide to see how well they work in treating patients with stage I, stage II, or stage III multiple myeloma.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically proven stage I-III multiple myeloma
Less than 18 months since diagnosis
Smoldering myeloma allowed if there is evidence of progressive disease requiring therapy
At least 25% increase in M protein levels or Bence Jones excretion
Hemoglobin no greater than 10.5 g/dL
Hypercalcemia
Frequent infections
Rise in serum creatinine above normal on 2 separate occasions
Nonquantifiable monoclonal proteins allowed if other criteria for multiple myeloma or smoldering myeloma are met
Response/status after induction therapy:
Responding or stable disease AND no greater than 40% myelomatous involvement of bone marrow
No Waldenstrom's macroglobulinemia

PATIENT CHARACTERISTICS:

Age:

65 and under

Performance status:

Karnofsky 80-100%

Life expectancy:

Not specified

Hematopoietic:

See Disease Characteristics
Absolute neutrophil count greater than 1,500/mm^3
Platelet count greater than 100,000/mm^3

Hepatic:

Bilirubin no greater than 1.5 mg/dL
Serum glutamic axaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) less than 2.5 times upper limit of normal
Hepatitis B antigen or hepatitis C ribonucleaic acid (RNA) negative

Renal:

See Disease Characteristics
Creatinine no greater than 1.4 mg/dL
Creatinine clearance greater than 65 mL/min

Cardiovascular:

Cardiac ejection fraction at least 50% by multigated acquisition scan (MUGA) or echocardiogram

Pulmonary:

Forced-expiratory volume in one second (FEV\_1) greater than 60% of normal
Diffusing capacity for carbon monoxide (DLCO) greater than 50% of predicted lower limit

Other:

Not pregnant
Negative pregnancy test
Fertile patients must use effective contraception
Human immunodeficiency virus (HIV) negative
No other medical or psychosocial problems that would increase patient risk
No other malignancy within past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix
No known hypersensitivity to filgrastim (G-CSF) or Escherechi coli-derived proteins

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

See Disease Characteristics
No more than 3 prior chemotherapy regimens
At least 4 weeks since prior chemotherapy

Endocrine therapy:

Not specified

Radiotherapy:

At least 4 weeks since prior radiotherapy

Surgery:

Not specified

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00004088). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.